1. data.fda.gov.tw
  2. 藥品法規條文資料集
  3. 1420574
column value
類別 化學製造管制類,藥品優良製造,藥品優良製造確效作業基準
法規性質 行政解釋
法規名稱 藥品優良製造確效作業基準
條文內容 <p style="text-align: center;"><b><span style="font-size: 13pt;"><a href="http://dohlaw.doh.gov.tw/Chi/FLAW/FLAWDAT01.asp?lsid=FL013827"><span style="font-family: 新細明體,serif; color: windowtext; text-decoration: none; text-underline: none;">藥品優良製造確效作業基準</span></a> </span></b></p><p style="text-align: center;"><span style="font-size: 10pt;">(</span><span style="font-family: 新細明體,serif; font-size: 10pt;">民國</span><span style="font-size: 10pt;"> 88 <span style="font-family: 新細明體,serif;">年</span> 04 <span style="font-family: 新細明體,serif;">月</span> 13 </span><span style="font-family: 新細明體,serif; font-size: 10pt;">日修正</span><span style="font-size: 10pt;">)</span> </p><table style="margin: auto auto auto 1.5pt; width: 100.92%;" border="0" cellpadding="0" width="100%"> <tbody> <tr> <td style="padding-bottom: 1.5pt; background-color: transparent; padding-left: 1.5pt; width: 99.3%; padding-right: 1.5pt; padding-top: 1.5pt;border-color: #f0f0f0;" colspan="2"> <p><b><span style="font-family: 新細明體,serif; font-size: 11pt;">第&nbsp;一&nbsp;編&nbsp;總則</span></b> </p> </td> </tr> <tr> <td style="padding-bottom: 1.5pt; background-color: transparent; padding-left: 1.5pt; width: 12.08%; padding-right: 1.5pt; white-space: nowrap; padding-top: 1.5pt;border-color: #f0f0f0;" valign="top"> <p><span style="font-family: 新細明體,serif; font-size: 11pt;"><a href="http://dohlaw.doh.gov.tw/Chi/FLAW/FLAWDOC01.asp?lsid=FL013827&amp;lno=1"><span style="color: windowtext; text-decoration: none; text-underline: none;">第 &nbsp;&nbsp;&nbsp;1&nbsp;&nbsp;&nbsp;&nbsp; </span><span style="color: windowtext; text-decoration: none; text-underline: none;">條</span></a> </span></p> </td> <td style="padding-bottom: 1.5pt; background-color: transparent; padding-left: 1.5pt; width: 86.86%; padding-right: 1.5pt; padding-top: 1.5pt;border-color: #f0f0f0;"> <p><span style="font-family: 細明體; font-size: 11pt;">本藥品優良製造確效作業基準 (以下簡稱本基準) ，為提升藥品品質、確 </span></p> <p><span style="font-family: 細明體; font-size: 11pt;">保藥品之有效性與安全性，進而達到國際水準，特制訂本基準。 </span></p> </td> </tr> <tr> <td style="padding-bottom: 1.5pt; background-color: transparent; padding-left: 1.5pt; width: 12.08%; padding-right: 1.5pt; white-space: nowrap; padding-top: 1.5pt;border-color: #f0f0f0;" valign="top"> <p><span style="font-family: 新細明體,serif; font-size: 11pt;"><a href="http://dohlaw.doh.gov.tw/Chi/FLAW/FLAWDOC01.asp?lsid=FL013827&amp;lno=2"><span style="color: windowtext; text-decoration: none; text-underline: none;">第 &nbsp;&nbsp;&nbsp;2&nbsp;&nbsp;&nbsp;&nbsp; </span><span style="color: windowtext; text-decoration: none; text-underline: none;">條</span></a> </span></p> </td> <td style="padding-bottom: 1.5pt; background-color: transparent; padding-left: 1.5pt; width: 86.86%; padding-right: 1.5pt; padding-top: 1.5pt;border-color: #f0f0f0;"> <p><span style="font-family: 細明體; font-size: 11pt;">藥廠應依本基準，以適當之方法，針對下列事項之適當性，進行確效：支 </span></p> <p><span style="font-family: 細明體; font-size: 11pt;">援系統 (包括供水與空氣處理系統) ，設備之安裝、操作及其性能，設備 </span></p> <p><span style="font-family: 細明體; font-size: 11pt;">之清潔，製程及各種分析方法等。未列入之其他各種運作亦應視必要性自 </span></p> <p><span style="font-family: 細明體; font-size: 11pt;">行，或由主管單位指定實施。 </span></p> </td> </tr> <tr> <td style="padding-bottom: 1.5pt; background-color: transparent; padding-left: 1.5pt; width: 12.08%; padding-right: 1.5pt; white-space: nowrap; padding-top: 1.5pt;border-color: #f0f0f0;" valign="top"> <p><span style="font-family: 新細明體,serif; font-size: 11pt;"><a href="http://dohlaw.doh.gov.tw/Chi/FLAW/FLAWDOC01.asp?lsid=FL013827&amp;lno=3"><span style="color: windowtext; text-decoration: none; text-underline: none;">第 &nbsp;&nbsp;&nbsp;3&nbsp;&nbsp;&nbsp;&nbsp; </span><span style="color: windowtext; text-decoration: none; text-underline: none;">條</span></a> </span></p> </td> <td style="padding-bottom: 1.5pt; background-color: transparent; padding-left: 1.5pt; width: 86.86%; padding-right: 1.5pt; padding-top: 1.5pt;border-color: #f0f0f0;"> <p><span style="font-family: 細明體; font-size: 11pt;">進行各種確效時，藥廠得不依據本基準所列舉之方法，而自行採用其他可 </span></p> <p><span style="font-family: 細明體; font-size: 11pt;">行之科學方法，惟應能擬達本目標。 </span></p> </td> </tr> <tr> <td style="padding-bottom: 1.5pt; background-color: transparent; padding-left: 1.5pt; width: 12.08%; padding-right: 1.5pt; white-space: nowrap; padding-top: 1.5pt;border-color: #f0f0f0;" valign="top"> <p><span style="font-family: 新細明體,serif; font-size: 11pt;"><a href="http://dohlaw.doh.gov.tw/Chi/FLAW/FLAWDOC01.asp?lsid=FL013827&amp;lno=4"><span style="color: windowtext; text-decoration: none; text-underline: none;">第 &nbsp;&nbsp;&nbsp;4&nbsp;&nbsp;&nbsp;&nbsp; </span><span style="color: windowtext; text-decoration: none; text-underline: none;">條</span></a> </span></p> </td> <td style="padding-bottom: 1.5pt; background-color: transparent; padding-left: 1.5pt; width: 86.86%; padding-right: 1.5pt; padding-top: 1.5pt;border-color: #f0f0f0;"> <p><span style="font-family: 細明體; font-size: 11pt;">本基準之專用名詞其意義如下： </span></p> <p><span style="font-family: 細明體; font-size: 11pt;">一&nbsp; 確效：係指有文件證明的行動，能證實程序、製程、機械設備、原材 </span></p> <p><span style="font-family: 細明體; font-size: 11pt;">&nbsp;&nbsp;&nbsp; </span><span style="font-family: 細明體; font-size: 11pt;">料或系統確實能持續穩定的導致預期之效果。 </span></p> <p><span style="font-family: 細明體; font-size: 11pt;">二&nbsp; 驗證：為對於設施及設備本身之性能確認有關事宜。 </span></p> <p><span style="font-family: 細明體; font-size: 11pt;">三&nbsp; 安裝驗證：為一種確認作業，旨在確認設施或設備於既訂條件下安裝 </span></p> <p><span style="font-family: 細明體; font-size: 11pt;">&nbsp;&nbsp;&nbsp; </span><span style="font-family: 細明體; font-size: 11pt;">，並能於限制條件與耐受範圍內呈現恆定性能之措施。 </span></p> <p><span style="font-family: 細明體; font-size: 11pt;">四&nbsp; 操作驗證：為一種確認作業，旨在確驗設施或設備於其操作極限範圍 </span></p> <p><span style="font-family: 細明體; font-size: 11pt;">&nbsp;&nbsp;&nbsp; </span><span style="font-family: 細明體; font-size: 11pt;">與正常範圍內能適當運轉。 </span></p> <p><span style="font-family: 細明體; font-size: 11pt;">五&nbsp; 性能驗證：為一種確認作業，為操作驗證之一種，旨在確認設備或設 </span></p> <p><span style="font-family: 細明體; font-size: 11pt;">&nbsp;&nbsp;&nbsp; </span><span style="font-family: 細明體; font-size: 11pt;">施能持續穩定的表現其應有之性能。 </span></p> <p><span style="font-family: 細明體; font-size: 11pt;">六&nbsp; 製程確效：確認產品之製造程序及其管制條件，具有良好的有效性與 </span></p> <p><span style="font-family: 細明體; font-size: 11pt;">&nbsp;&nbsp;&nbsp; </span><span style="font-family: 細明體; font-size: 11pt;">再現性。 </span></p> <p><span style="font-family: 細明體; font-size: 11pt;">七&nbsp; 產品確效：對由特定製程生產所得之產品作適當之測試，以確認產品 </span></p> <p><span style="font-family: 細明體; font-size: 11pt;">&nbsp;&nbsp;&nbsp; </span><span style="font-family: 細明體; font-size: 11pt;">於放行時，能符合所應有的特性與安全性。 </span></p> <p><span style="font-family: 細明體; font-size: 11pt;">八&nbsp; 先期性確效：為一種產品於上市前所進行之確效措施，適用於下列兩 </span></p> <p><span style="font-family: 細明體; font-size: 11pt;">&nbsp;&nbsp;&nbsp; </span><span style="font-family: 細明體; font-size: 11pt;">類產品： </span></p> <p><span style="font-family: 細明體; font-size: 11pt;">&nbsp;(</span><span style="font-family: 細明體; font-size: 11pt;">一) 新產品：新申請查驗登記之產品。 </span></p> <p><span style="font-family: 細明體; font-size: 11pt;">&nbsp;(</span><span style="font-family: 細明體; font-size: 11pt;">二) 既有產品於更改配方 (包括成分及組成) 、製造場所、製造設備、 </span></p> <p><span style="font-family: 細明體; font-size: 11pt;">&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; </span><span style="font-family: 細明體; font-size: 11pt;">製程等製造條件而可能會重大影響產品之品質特性者。 </span></p> <p><span style="font-family: 細明體; font-size: 11pt;">九&nbsp; 回溯性確效：對一特定之產品而言，利用以往生產、測試與管制之累 </span></p> <p><span style="font-family: 細明體; font-size: 11pt;">&nbsp;&nbsp;&nbsp; </span><span style="font-family: 細明體; font-size: 11pt;">積數據，對已上市產品，所作之製程確效，通常以連續十批以上產品 </span></p> <p><span style="font-family: 細明體; font-size: 11pt;">&nbsp;&nbsp;&nbsp; </span><span style="font-family: 細明體; font-size: 11pt;">之相關數據行之。 </span></p> <p><span style="font-family: 細明體; font-size: 11pt;">一○&nbsp; 併行性確效：對一特定之產品而言，依照實際生產之規模及條件， </span></p> <p><span style="font-family: 細明體; font-size: 11pt;">&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; </span><span style="font-family: 細明體; font-size: 11pt;">就所製造之連續三批該產品所作之製程確效。 </span></p> <p><span style="font-family: 細明體; font-size: 11pt;">一一&nbsp; 再確效：再確效為對一通過確效之特定產品，重行確效之措施，可 </span></p> <p><span style="font-family: 細明體; font-size: 11pt;">&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; </span><span style="font-family: 細明體; font-size: 11pt;">分下列兩種： </span></p> <p><span style="font-family: 細明體; font-size: 11pt;">&nbsp;&nbsp; (</span><span style="font-family: 細明體; font-size: 11pt;">一) 於原料、設施或設備、製造場所、或製造方法有異動時，應進行 </span></p> <p><span style="font-family: 細明體; font-size: 11pt;">&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; </span><span style="font-family: 細明體; font-size: 11pt;">之確效。 </span></p> <p><span style="font-family: 細明體; font-size: 11pt;">&nbsp;&nbsp; (</span><span style="font-family: 細明體; font-size: 11pt;">二) 當併行性確效與回溯性確效之數據不充分，而不能供趨勢分析時 </span></p> <p><span style="font-family: 細明體; font-size: 11pt;">&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; </span><span style="font-family: 細明體; font-size: 11pt;">，應進行定期再確效。 </span></p> <p><span style="font-family: 細明體; font-size: 11pt;">一二&nbsp; 確效計畫書：說明將如何進行確效之書面計畫書，內容包括予以測 </span></p> <p><span style="font-family: 細明體; font-size: 11pt;">&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; </span><span style="font-family: 細明體; font-size: 11pt;">試之指標，產品特質，生產設備，以及測試合格之判定標準。 </span></p> <p><span style="font-family: 細明體; font-size: 11pt;">一三&nbsp; 最差狀況：為最能導致製程或產品的失敗之條件，包含製程與環境 </span></p> <p><span style="font-family: 細明體; font-size: 11pt;">&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; </span><span style="font-family: 細明體; font-size: 11pt;">之最高與最低極限條件，以及處於標準操作程序內最能引起製程或 </span></p> <p><span style="font-family: 細明體; font-size: 11pt;">&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; </span><span style="font-family: 細明體; font-size: 11pt;">產品的失敗之條件。 </span></p> </td> </tr> <tr> <td style="padding-bottom: 1.5pt; background-color: transparent; padding-left: 1.5pt; width: 12.08%; padding-right: 1.5pt; white-space: nowrap; padding-top: 1.5pt;border-color: #f0f0f0;" valign="top"> <p><span style="font-family: 新細明體,serif; font-size: 11pt;"><a href="http://dohlaw.doh.gov.tw/Chi/FLAW/FLAWDOC01.asp?lsid=FL013827&amp;lno=5"><span style="color: windowtext; text-decoration: none; text-underline: none;">第 &nbsp;&nbsp;&nbsp;5&nbsp;&nbsp;&nbsp;&nbsp; </span><span style="color: windowtext; text-decoration: none; text-underline: none;">條</span></a> </span></p> </td> <td style="padding-bottom: 1.5pt; background-color: transparent; padding-left: 1.5pt; width: 86.86%; padding-right: 1.5pt; padding-top: 1.5pt;border-color: #f0f0f0;"> <p><span style="font-family: 細明體; font-size: 11pt;">藥廠應設置專責部門或由品質管理單位，負責主持確效作業，並指派專人 </span></p> <p><span style="font-family: 細明體; font-size: 11pt;">負責籌劃，協調並監督有關事務。各部門進行確效作業時，應有品質管理 </span></p> <p><span style="font-family: 細明體; font-size: 11pt;">人員配合參與。 </span></p> </td> </tr> <tr> <td style="padding-bottom: 1.5pt; background-color: transparent; padding-left: 1.5pt; width: 12.08%; padding-right: 1.5pt; white-space: nowrap; padding-top: 1.5pt;border-color: #f0f0f0;" valign="top"> <p><span style="font-family: 新細明體,serif; font-size: 11pt;"><a href="http://dohlaw.doh.gov.tw/Chi/FLAW/FLAWDOC01.asp?lsid=FL013827&amp;lno=6"><span style="color: windowtext; text-decoration: none; text-underline: none;">第 &nbsp;&nbsp;&nbsp;6&nbsp;&nbsp;&nbsp;&nbsp; </span><span style="color: windowtext; text-decoration: none; text-underline: none;">條</span></a> </span></p> </td> <td style="padding-bottom: 1.5pt; background-color: transparent; padding-left: 1.5pt; width: 86.86%; padding-right: 1.5pt; padding-top: 1.5pt;border-color: #f0f0f0;"> <p><span style="font-family: 細明體; font-size: 11pt;">藥廠訂有確效作業之整體計畫，內容包括下列事項： </span></p> <p><span style="font-family: 細明體; font-size: 11pt;">一&nbsp; 目錄。 </span></p> <p><span style="font-family: 細明體; font-size: 11pt;">二&nbsp; 確效作業概述及目標。 </span></p> <p><span style="font-family: 細明體; font-size: 11pt;">三&nbsp; 確效專責部門之組織、人事及權責。 </span></p> <p><span style="font-family: 細明體; font-size: 11pt;">四&nbsp; 所用辭彙之定義。 </span></p> <p><span style="font-family: 細明體; font-size: 11pt;">五&nbsp; 各種設施及設備之性狀描述及資料。 </span></p> <p><span style="font-family: 細明體; font-size: 11pt;">六&nbsp; 建築物書面資料。 </span></p> <p><span style="font-family: 細明體; font-size: 11pt;">七&nbsp; 各種確效作業之計畫書。 </span></p> <p><span style="font-family: 細明體; font-size: 11pt;">八&nbsp; 各種確效標準作業程序。 </span></p> <p><span style="font-family: 細明體; font-size: 11pt;">九&nbsp; 預防性維護作業及矯正作業計畫。 </span></p> <p><span style="font-family: 細明體; font-size: 11pt;">一○&nbsp; 人員培訓計畫。 </span></p> <p><span style="font-family: 細明體; font-size: 11pt;">一一&nbsp; 書面資料之保存規定。 </span></p> <p><span style="font-family: 細明體; font-size: 11pt;">一二&nbsp; 計畫書範例。 </span></p> <p><span style="font-family: 細明體; font-size: 11pt;">一三&nbsp; 確效標準作業程序範例。 </span></p> <p><span style="font-family: 細明體; font-size: 11pt;">一四&nbsp; 確效計畫之批准實施。 </span></p> </td> </tr> <tr> <td style="padding-bottom: 1.5pt; background-color: transparent; padding-left: 1.5pt; width: 12.08%; padding-right: 1.5pt; white-space: nowrap; padding-top: 1.5pt;border-color: #f0f0f0;" valign="top"> <p><span style="font-family: 新細明體,serif; font-size: 11pt;"><a href="http://dohlaw.doh.gov.tw/Chi/FLAW/FLAWDOC01.asp?lsid=FL013827&amp;lno=7"><span style="color: windowtext; text-decoration: none; text-underline: none;">第 &nbsp;&nbsp;&nbsp;7&nbsp;&nbsp;&nbsp;&nbsp; </span><span style="color: windowtext; text-decoration: none; text-underline: none;">條</span></a> </span></p> </td> <td style="padding-bottom: 1.5pt; background-color: transparent; padding-left: 1.5pt; width: 86.86%; padding-right: 1.5pt; padding-top: 1.5pt;border-color: #f0f0f0;"> <p><span style="font-family: 細明體; font-size: 11pt;">針對各項確效及驗證作業，分別制訂確效計畫書，內容包括下列各項： </span></p> <p><span style="font-family: 細明體; font-size: 11pt;">一&nbsp; 確效或驗證之項目。 </span></p> <p><span style="font-family: 細明體; font-size: 11pt;">二&nbsp; 確效或驗證之目的整體目標。 </span></p> <p><span style="font-family: 細明體; font-size: 11pt;">三&nbsp; 預定實施頻率。 </span></p> <p><span style="font-family: 細明體; font-size: 11pt;">四&nbsp; 該項確效或驗證之計畫書制訂及各次改訂日期，以及改訂事項。 </span></p> <p><span style="font-family: 細明體; font-size: 11pt;">五&nbsp; 確效或驗證方法。 </span></p> <p><span style="font-family: 細明體; font-size: 11pt;">六&nbsp; 合格標準範圍。 </span></p> <p><span style="font-family: 細明體; font-size: 11pt;">七&nbsp; 數據或資料處理方法。 </span></p> <p><span style="font-family: 細明體; font-size: 11pt;">八&nbsp; 確效或驗證書面資料之改訂程序及保管相關事項。 </span></p> <p><span style="font-family: 細明體; font-size: 11pt;">九&nbsp; 執行確效或驗證之責任單位及負責人員。 </span></p> </td> </tr> <tr> <td style="padding-bottom: 1.5pt; background-color: transparent; padding-left: 1.5pt; width: 12.08%; padding-right: 1.5pt; white-space: nowrap; padding-top: 1.5pt;border-color: #f0f0f0;" valign="top"> <p><span style="font-family: 新細明體,serif; font-size: 11pt;"><a href="http://dohlaw.doh.gov.tw/Chi/FLAW/FLAWDOC01.asp?lsid=FL013827&amp;lno=8"><span style="color: windowtext; text-decoration: none; text-underline: none;">第 &nbsp;&nbsp;&nbsp;8&nbsp;&nbsp;&nbsp;&nbsp; </span><span style="color: windowtext; text-decoration: none; text-underline: none;">條</span></a> </span></p> </td> <td style="padding-bottom: 1.5pt; background-color: transparent; padding-left: 1.5pt; width: 86.86%; padding-right: 1.5pt; padding-top: 1.5pt;border-color: #f0f0f0;"> <p><span style="font-family: 細明體; font-size: 11pt;">各種確效或驗證計畫書應由權責單位及人員核定。針對各種確效或驗證作 </span></p> <p><span style="font-family: 細明體; font-size: 11pt;">業應有因應之標準作業程序。各種標準作業程序應載有制訂人、核定人、 </span></p> <p><span style="font-family: 細明體; font-size: 11pt;">制訂日期及核定日期。 </span></p> </td> </tr> <tr> <td style="padding-bottom: 1.5pt; background-color: transparent; padding-left: 1.5pt; width: 12.08%; padding-right: 1.5pt; white-space: nowrap; padding-top: 1.5pt;border-color: #f0f0f0;" valign="top"> <p><span style="font-family: 新細明體,serif; font-size: 11pt;"><a href="http://dohlaw.doh.gov.tw/Chi/FLAW/FLAWDOC01.asp?lsid=FL013827&amp;lno=9"><span style="color: windowtext; text-decoration: none; text-underline: none;">第 &nbsp;&nbsp;&nbsp;9&nbsp;&nbsp;&nbsp;&nbsp; </span><span style="color: windowtext; text-decoration: none; text-underline: none;">條</span></a> </span></p> </td> <td style="padding-bottom: 1.5pt; background-color: transparent; padding-left: 1.5pt; width: 86.86%; padding-right: 1.5pt; padding-top: 1.5pt;border-color: #f0f0f0;"> <p><span style="font-family: 細明體; font-size: 11pt;">確效作業之結果應包括與確效計畫書各項對應之各種資料及數據，各別確 </span></p> <p><span style="font-family: 細明體; font-size: 11pt;">效作業特別之指標資料及數據，於各該章中另再指定之。 </span></p> <p><span style="font-family: 細明體; font-size: 11pt;">確效作業之研究結果應彙集成檔。經過批准的確效報告中，應書明所確效 </span></p> <p><span style="font-family: 細明體; font-size: 11pt;">之事項是否符合確效標準，並以科學數據證明有關符合既訂標準之推判。 </span></p> </td> </tr> <tr> <td style="padding-bottom: 1.5pt; background-color: transparent; padding-left: 1.5pt; width: 99.3%; padding-right: 1.5pt; padding-top: 1.5pt;border-color: #f0f0f0;" colspan="2"> <p><b><span style="font-family: 新細明體,serif; font-size: 11pt;">第&nbsp;二&nbsp;編&nbsp;設施、設備</span></b> </p> </td> </tr> <tr> <td style="padding-bottom: 1.5pt; background-color: transparent; padding-left: 1.5pt; width: 99.3%; padding-right: 1.5pt; padding-top: 1.5pt;border-color: #f0f0f0;" colspan="2"> <p><b><span style="font-family: 新細明體,serif; font-size: 11pt;">&nbsp;&nbsp;&nbsp;</span></b><b><span style="font-family: 新細明體,serif; font-size: 11pt;">第&nbsp;一&nbsp;章&nbsp;設施與設備之確效</span></b> </p> </td> </tr> <tr> <td style="padding-bottom: 1.5pt; background-color: transparent; padding-left: 1.5pt; width: 99.3%; padding-right: 1.5pt; padding-top: 1.5pt;border-color: #f0f0f0;" colspan="2"> <p><b><span style="font-family: 新細明體,serif; font-size: 11pt;">&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;</span></b><b><span style="font-family: 新細明體,serif; font-size: 11pt;">第&nbsp;一&nbsp;節&nbsp;安裝驗證</span></b> </p> </td> </tr> <tr> <td style="padding-bottom: 1.5pt; background-color: transparent; padding-left: 1.5pt; width: 12.08%; padding-right: 1.5pt; white-space: nowrap; padding-top: 1.5pt;border-color: #f0f0f0;" valign="top"> <p><span style="font-family: 新細明體,serif; font-size: 11pt;"><a href="http://dohlaw.doh.gov.tw/Chi/FLAW/FLAWDOC01.asp?lsid=FL013827&amp;lno=10"><span style="color: windowtext; text-decoration: none; text-underline: none;">第 &nbsp;&nbsp;10&nbsp;&nbsp;&nbsp;&nbsp; </span><span style="color: windowtext; text-decoration: none; text-underline: none;">條</span></a> </span></p> </td> <td style="padding-bottom: 1.5pt; background-color: transparent; padding-left: 1.5pt; width: 86.86%; padding-right: 1.5pt; padding-top: 1.5pt;border-color: #f0f0f0;"> <p><span style="font-family: 細明體; font-size: 11pt;">藥廠於設置一設施或安裝設備時，應進行安全驗證，以確定該設施或設備 </span></p> <p><span style="font-family: 細明體; font-size: 11pt;">符合原設計規格與條件。 </span></p> </td> </tr> <tr> <td style="padding-bottom: 1.5pt; background-color: transparent; padding-left: 1.5pt; width: 12.08%; padding-right: 1.5pt; white-space: nowrap; padding-top: 1.5pt;border-color: #f0f0f0;" valign="top"> <p><span style="font-family: 新細明體,serif; font-size: 11pt;"><a href="http://dohlaw.doh.gov.tw/Chi/FLAW/FLAWDOC01.asp?lsid=FL013827&amp;lno=11"><span style="color: windowtext; text-decoration: none; text-underline: none;">第 &nbsp;&nbsp;11&nbsp;&nbsp;&nbsp;&nbsp; </span><span style="color: windowtext; text-decoration: none; text-underline: none;">條</span></a> </span></p> </td> <td style="padding-bottom: 1.5pt; background-color: transparent; padding-left: 1.5pt; width: 86.86%; padding-right: 1.5pt; padding-top: 1.5pt;border-color: #f0f0f0;"> <p><span style="font-family: 細明體; font-size: 11pt;">本項驗證作業計畫書，得以圖示、表列等方式輔佐文字說明。 </span></p> </td> </tr> <tr> <td style="padding-bottom: 1.5pt; background-color: transparent; padding-left: 1.5pt; width: 12.08%; padding-right: 1.5pt; white-space: nowrap; padding-top: 1.5pt;border-color: #f0f0f0;" valign="top"> <p><span style="font-family: 新細明體,serif; font-size: 11pt;"><a href="http://dohlaw.doh.gov.tw/Chi/FLAW/FLAWDOC01.asp?lsid=FL013827&amp;lno=12"><span style="color: windowtext; text-decoration: none; text-underline: none;">第 &nbsp;&nbsp;12&nbsp;&nbsp;&nbsp;&nbsp; </span><span style="color: windowtext; text-decoration: none; text-underline: none;">條</span></a> </span></p> </td> <td style="padding-bottom: 1.5pt; background-color: transparent; padding-left: 1.5pt; width: 86.86%; padding-right: 1.5pt; padding-top: 1.5pt;border-color: #f0f0f0;"> <p><span style="font-family: 細明體; font-size: 11pt;">本項驗證作業計畫書包括下列事項： </span></p> <p><span style="font-family: 細明體; font-size: 11pt;">一&nbsp; 驗證頻率及名稱。 </span></p> <p><span style="font-family: 細明體; font-size: 11pt;">二&nbsp; 本驗證作業概述及相關背景說明。 </span></p> <p><span style="font-family: 細明體; font-size: 11pt;">三&nbsp; 各種有關之識別資料，包括該設施或設備之編號，及標準作業程序之 </span></p> <p><span style="font-family: 細明體; font-size: 11pt;">&nbsp;&nbsp;&nbsp; </span><span style="font-family: 細明體; font-size: 11pt;">編號等。 </span></p> <p><span style="font-family: 細明體; font-size: 11pt;">四&nbsp; 該項設施或設備安置之目的。 </span></p> <p><span style="font-family: 細明體; font-size: 11pt;">五&nbsp; 該項設施或設備之材資、設計及結構。 </span></p> <p><span style="font-family: 細明體; font-size: 11pt;">六&nbsp; 運轉或維護該項設施或設備所須之支援事項及擬提供配合之內容。 </span></p> <p><span style="font-family: 細明體; font-size: 11pt;">七&nbsp; 合格標準。 </span></p> <p><span style="font-family: 細明體; font-size: 11pt;">八&nbsp; 計畫書之制訂人、核定人及制訂、核定日期。 </span></p> </td> </tr> <tr> <td style="padding-bottom: 1.5pt; background-color: transparent; padding-left: 1.5pt; width: 12.08%; padding-right: 1.5pt; white-space: nowrap; padding-top: 1.5pt;border-color: #f0f0f0;" valign="top"> <p><span style="font-family: 新細明體,serif; font-size: 11pt;"><a href="http://dohlaw.doh.gov.tw/Chi/FLAW/FLAWDOC01.asp?lsid=FL013827&amp;lno=13"><span style="color: windowtext; text-decoration: none; text-underline: none;">第 &nbsp;&nbsp;13&nbsp;&nbsp;&nbsp;&nbsp; </span><span style="color: windowtext; text-decoration: none; text-underline: none;">條</span></a> </span></p> </td> <td style="padding-bottom: 1.5pt; background-color: transparent; padding-left: 1.5pt; width: 86.86%; padding-right: 1.5pt; padding-top: 1.5pt;border-color: #f0f0f0;"> <p><span style="font-family: 細明體; font-size: 11pt;">完成安裝驗證後，應彙整所有數據資料，判斷是否合格，並由權責單位及 </span></p> <p><span style="font-family: 細明體; font-size: 11pt;">有關人員核可後再進行操作驗證。 </span></p> </td> </tr> <tr> <td style="padding-bottom: 1.5pt; background-color: transparent; padding-left: 1.5pt; width: 99.3%; padding-right: 1.5pt; padding-top: 1.5pt;border-color: #f0f0f0;" colspan="2"> <p><b><span style="font-family: 新細明體,serif; font-size: 11pt;">&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;</span></b><b><span style="font-family: 新細明體,serif; font-size: 11pt;">第&nbsp;二&nbsp;節&nbsp;操作驗證與性能驗證</span></b> </p> </td> </tr> <tr> <td style="padding-bottom: 1.5pt; background-color: transparent; padding-left: 1.5pt; width: 12.08%; padding-right: 1.5pt; white-space: nowrap; padding-top: 1.5pt;border-color: #f0f0f0;" valign="top"> <p><span style="font-family: 新細明體,serif; font-size: 11pt;"><a href="http://dohlaw.doh.gov.tw/Chi/FLAW/FLAWDOC01.asp?lsid=FL013827&amp;lno=14"><span style="color: windowtext; text-decoration: none; text-underline: none;">第 &nbsp;&nbsp;14&nbsp;&nbsp;&nbsp;&nbsp; </span><span style="color: windowtext; text-decoration: none; text-underline: none;">條</span></a> </span></p> </td> <td style="padding-bottom: 1.5pt; background-color: transparent; padding-left: 1.5pt; width: 86.86%; padding-right: 1.5pt; padding-top: 1.5pt;border-color: #f0f0f0;"> <p><span style="font-family: 細明體; font-size: 11pt;">設施或設備於安裝驗證合格後，應執行該設施或設備之操作驗證，以確定 </span></p> <p><span style="font-family: 細明體; font-size: 11pt;">該設施或設備於其操作正常範圍內能適當運轉，必要時得以極限範圍適當 </span></p> <p><span style="font-family: 細明體; font-size: 11pt;">運轉之。 </span></p> </td> </tr> <tr> <td style="padding-bottom: 1.5pt; background-color: transparent; padding-left: 1.5pt; width: 12.08%; padding-right: 1.5pt; white-space: nowrap; padding-top: 1.5pt;border-color: #f0f0f0;" valign="top"> <p><span style="font-family: 新細明體,serif; font-size: 11pt;"><a href="http://dohlaw.doh.gov.tw/Chi/FLAW/FLAWDOC01.asp?lsid=FL013827&amp;lno=15"><span style="color: windowtext; text-decoration: none; text-underline: none;">第 &nbsp;&nbsp;15&nbsp;&nbsp;&nbsp;&nbsp; </span><span style="color: windowtext; text-decoration: none; text-underline: none;">條</span></a> </span></p> </td> <td style="padding-bottom: 1.5pt; background-color: transparent; padding-left: 1.5pt; width: 86.86%; padding-right: 1.5pt; padding-top: 1.5pt;border-color: #f0f0f0;"> <p><span style="font-family: 細明體; font-size: 11pt;">本項驗證作業之方法應依各設施或設備之本質分別訂定。驗證之試驗內容 </span></p> <p><span style="font-family: 細明體; font-size: 11pt;">應能表現該設施或設備是否適當適轉。 </span></p> </td> </tr> <tr> <td style="padding-bottom: 1.5pt; background-color: transparent; padding-left: 1.5pt; width: 12.08%; padding-right: 1.5pt; white-space: nowrap; padding-top: 1.5pt;border-color: #f0f0f0;" valign="top"> <p><span style="font-family: 新細明體,serif; font-size: 11pt;"><a href="http://dohlaw.doh.gov.tw/Chi/FLAW/FLAWDOC01.asp?lsid=FL013827&amp;lno=16"><span style="color: windowtext; text-decoration: none; text-underline: none;">第 &nbsp;&nbsp;16&nbsp;&nbsp;&nbsp;&nbsp; </span><span style="color: windowtext; text-decoration: none; text-underline: none;">條</span></a> </span></p> </td> <td style="padding-bottom: 1.5pt; background-color: transparent; padding-left: 1.5pt; width: 86.86%; padding-right: 1.5pt; padding-top: 1.5pt;border-color: #f0f0f0;"> <p><span style="font-family: 細明體; font-size: 11pt;">驗證計畫書包括下列事項： </span></p> <p><span style="font-family: 細明體; font-size: 11pt;">一&nbsp; 驗證頻率及名稱。 </span></p> <p><span style="font-family: 細明體; font-size: 11pt;">二&nbsp; 驗證作業概述及相關背景說明。 </span></p> <p><span style="font-family: 細明體; font-size: 11pt;">三&nbsp; 各種有關之識別資料，包括該設施或設備之財產編號，及標準作業程 </span></p> <p><span style="font-family: 細明體; font-size: 11pt;">&nbsp;&nbsp;&nbsp; </span><span style="font-family: 細明體; font-size: 11pt;">序之編號等。 </span></p> <p><span style="font-family: 細明體; font-size: 11pt;">四&nbsp; 目視檢查項目。 </span></p> <p><span style="font-family: 細明體; font-size: 11pt;">五&nbsp; 各種開關及指示燈之功能檢查。 </span></p> <p><span style="font-family: 細明體; font-size: 11pt;">六&nbsp; 與產品品質相關之各種感應器、探針、壓力針、記錄器、空氣流速計 </span></p> <p><span style="font-family: 細明體; font-size: 11pt;">&nbsp;&nbsp;&nbsp; </span><span style="font-family: 細明體; font-size: 11pt;">、流通方向、壓力及溫度等之功能檢查及校正。 </span></p> <p><span style="font-family: 細明體; font-size: 11pt;">七&nbsp; 濾器之功能與有效性試驗。 </span></p> <p><span style="font-family: 細明體; font-size: 11pt;">八&nbsp; 清潔方法。 </span></p> <p><span style="font-family: 細明體; font-size: 11pt;">九&nbsp; 驗證用儀器。 </span></p> <p><span style="font-family: 細明體; font-size: 11pt;">一○&nbsp; 驗證之合格標準。 </span></p> <p><span style="font-family: 細明體; font-size: 11pt;">一一&nbsp; 採用之統計學試驗設計與數據處理方法。 </span></p> <p><span style="font-family: 細明體; font-size: 11pt;">一二&nbsp; 依試驗結果之建議事項。 </span></p> <p><span style="font-family: 細明體; font-size: 11pt;">一三&nbsp; 例行再驗證之時間表及須作非例行再驗證之指標。 </span></p> <p><span style="font-family: 細明體; font-size: 11pt;">一四&nbsp; 計畫書之制訂人、核定人及制訂、核定日期。 </span></p> </td> </tr> <tr> <td style="padding-bottom: 1.5pt; background-color: transparent; padding-left: 1.5pt; width: 12.08%; padding-right: 1.5pt; white-space: nowrap; padding-top: 1.5pt;border-color: #f0f0f0;" valign="top"> <p><span style="font-family: 新細明體,serif; font-size: 11pt;"><a href="http://dohlaw.doh.gov.tw/Chi/FLAW/FLAWDOC01.asp?lsid=FL013827&amp;lno=17"><span style="color: windowtext; text-decoration: none; text-underline: none;">第 &nbsp;&nbsp;17&nbsp;&nbsp;&nbsp;&nbsp; </span><span style="color: windowtext; text-decoration: none; text-underline: none;">條</span></a> </span></p> </td> <td style="padding-bottom: 1.5pt; background-color: transparent; padding-left: 1.5pt; width: 86.86%; padding-right: 1.5pt; padding-top: 1.5pt;border-color: #f0f0f0;"> <p><span style="font-family: 細明體; font-size: 11pt;">必要時在空轉或負載下進行設施或設備之性能驗證，以確認該設施或設備 </span></p> <p><span style="font-family: 細明體; font-size: 11pt;">之基本性能。 </span></p> </td> </tr> <tr> <td style="padding-bottom: 1.5pt; background-color: transparent; padding-left: 1.5pt; width: 12.08%; padding-right: 1.5pt; white-space: nowrap; padding-top: 1.5pt;border-color: #f0f0f0;" valign="top"> <p><span style="font-family: 新細明體,serif; font-size: 11pt;"><a href="http://dohlaw.doh.gov.tw/Chi/FLAW/FLAWDOC01.asp?lsid=FL013827&amp;lno=18"><span style="color: windowtext; text-decoration: none; text-underline: none;">第 &nbsp;&nbsp;18&nbsp;&nbsp;&nbsp;&nbsp; </span><span style="color: windowtext; text-decoration: none; text-underline: none;">條</span></a> </span></p> </td> <td style="padding-bottom: 1.5pt; background-color: transparent; padding-left: 1.5pt; width: 86.86%; padding-right: 1.5pt; padding-top: 1.5pt;border-color: #f0f0f0;"> <p><span style="font-family: 細明體; font-size: 11pt;">本項驗證作業之驗證報告書中，得以試驗結果輔佐文字說明。 </span></p> </td> </tr> <tr> <td style="padding-bottom: 1.5pt; background-color: transparent; padding-left: 1.5pt; width: 99.3%; padding-right: 1.5pt; padding-top: 1.5pt;border-color: #f0f0f0;" colspan="2"> <p><b><span style="font-family: 新細明體,serif; font-size: 11pt;">&nbsp;&nbsp;&nbsp;</span></b><b><span style="font-family: 新細明體,serif; font-size: 11pt;">第&nbsp;二&nbsp;章&nbsp;設備清潔方法之確效</span></b> </p> </td> </tr> <tr> <td style="padding-bottom: 1.5pt; background-color: transparent; padding-left: 1.5pt; width: 12.08%; padding-right: 1.5pt; white-space: nowrap; padding-top: 1.5pt;border-color: #f0f0f0;" valign="top"> <p><span style="font-family: 新細明體,serif; font-size: 11pt;"><a href="http://dohlaw.doh.gov.tw/Chi/FLAW/FLAWDOC01.asp?lsid=FL013827&amp;lno=19"><span style="color: windowtext; text-decoration: none; text-underline: none;">第 &nbsp;&nbsp;19&nbsp;&nbsp;&nbsp;&nbsp; </span><span style="color: windowtext; text-decoration: none; text-underline: none;">條</span></a> </span></p> </td> <td style="padding-bottom: 1.5pt; background-color: transparent; padding-left: 1.5pt; width: 86.86%; padding-right: 1.5pt; padding-top: 1.5pt;border-color: #f0f0f0;"> <p><span style="font-family: 細明體; font-size: 11pt;">本章所稱清潔方法係指將設備上之殘留物去除之方法與過程。 </span></p> </td> </tr> <tr> <td style="padding-bottom: 1.5pt; background-color: transparent; padding-left: 1.5pt; width: 12.08%; padding-right: 1.5pt; white-space: nowrap; padding-top: 1.5pt;border-color: #f0f0f0;" valign="top"> <p><span style="font-family: 新細明體,serif; font-size: 11pt;"><a href="http://dohlaw.doh.gov.tw/Chi/FLAW/FLAWDOC01.asp?lsid=FL013827&amp;lno=20"><span style="color: windowtext; text-decoration: none; text-underline: none;">第 &nbsp;&nbsp;20&nbsp;&nbsp;&nbsp;&nbsp; </span><span style="color: windowtext; text-decoration: none; text-underline: none;">條</span></a> </span></p> </td> <td style="padding-bottom: 1.5pt; background-color: transparent; padding-left: 1.5pt; width: 86.86%; padding-right: 1.5pt; padding-top: 1.5pt;border-color: #f0f0f0;"> <p><span style="font-family: 細明體; font-size: 11pt;">製藥有關各種設備應於每次使用過後以適當方法清潔之。針對各種清潔方 </span></p> <p><span style="font-family: 細明體; font-size: 11pt;">法應分別訂有標準作業程序確實遵守之，於每次操作時以書面紀錄記載清 </span></p> <p><span style="font-family: 細明體; font-size: 11pt;">潔過程之執行情形。 </span></p> </td> </tr> <tr> <td style="padding-bottom: 1.5pt; background-color: transparent; padding-left: 1.5pt; width: 12.08%; padding-right: 1.5pt; white-space: nowrap; padding-top: 1.5pt;border-color: #f0f0f0;" valign="top"> <p><span style="font-family: 新細明體,serif; font-size: 11pt;"><a href="http://dohlaw.doh.gov.tw/Chi/FLAW/FLAWDOC01.asp?lsid=FL013827&amp;lno=21"><span style="color: windowtext; text-decoration: none; text-underline: none;">第 &nbsp;&nbsp;21&nbsp;&nbsp;&nbsp;&nbsp; </span><span style="color: windowtext; text-decoration: none; text-underline: none;">條</span></a> </span></p> </td> <td style="padding-bottom: 1.5pt; background-color: transparent; padding-left: 1.5pt; width: 86.86%; padding-right: 1.5pt; padding-top: 1.5pt;border-color: #f0f0f0;"> <p><span style="font-family: 細明體; font-size: 11pt;">在產製各批同種產品、改產製不同產品或改變清潔方法時，均應將清潔時 </span></p> <p><span style="font-family: 細明體; font-size: 11pt;">之各種差異事項列載於記錄中。 </span></p> </td> </tr> <tr> <td style="padding-bottom: 1.5pt; background-color: transparent; padding-left: 1.5pt; width: 12.08%; padding-right: 1.5pt; white-space: nowrap; padding-top: 1.5pt;border-color: #f0f0f0;" valign="top"> <p><span style="font-family: 新細明體,serif; font-size: 11pt;"><a href="http://dohlaw.doh.gov.tw/Chi/FLAW/FLAWDOC01.asp?lsid=FL013827&amp;lno=22"><span style="color: windowtext; text-decoration: none; text-underline: none;">第 &nbsp;&nbsp;22&nbsp;&nbsp;&nbsp;&nbsp; </span><span style="color: windowtext; text-decoration: none; text-underline: none;">條</span></a> </span></p> </td> <td style="padding-bottom: 1.5pt; background-color: transparent; padding-left: 1.5pt; width: 86.86%; padding-right: 1.5pt; padding-top: 1.5pt;border-color: #f0f0f0;"> <p><span style="font-family: 細明體; font-size: 11pt;">各種清潔方法應以確效作業驗證其適當性。執行確效作業前應先擬具確效 </span></p> <p><span style="font-family: 細明體; font-size: 11pt;">計畫書，內容應包括取樣法、檢測方法、標的物及其濃度上限等，經藥廠 </span></p> <p><span style="font-family: 細明體; font-size: 11pt;">內權責單位及主管人員之核定後實施。 </span></p> </td> </tr> <tr> <td style="padding-bottom: 1.5pt; background-color: transparent; padding-left: 1.5pt; width: 12.08%; padding-right: 1.5pt; white-space: nowrap; padding-top: 1.5pt;border-color: #f0f0f0;" valign="top"> <p><span style="font-family: 新細明體,serif; font-size: 11pt;"><a href="http://dohlaw.doh.gov.tw/Chi/FLAW/FLAWDOC01.asp?lsid=FL013827&amp;lno=23"><span style="color: windowtext; text-decoration: none; text-underline: none;">第 &nbsp;&nbsp;23&nbsp;&nbsp;&nbsp;&nbsp; </span><span style="color: windowtext; text-decoration: none; text-underline: none;">條</span></a> </span></p> </td> <td style="padding-bottom: 1.5pt; background-color: transparent; padding-left: 1.5pt; width: 86.86%; padding-right: 1.5pt; padding-top: 1.5pt;border-color: #f0f0f0;"> <p><span style="font-family: 細明體; font-size: 11pt;">確效時應依核定之確效標準作業計畫擬定確效標準作業程序，再據而進行 </span></p> <p><span style="font-family: 細明體; font-size: 11pt;">之；該標準作業程序上應載有負責執行之單位及人員、確效作業之核定、 </span></p> <p><span style="font-family: 細明體; font-size: 11pt;">清潔程度之判定標準及再確效日期。 </span></p> </td> </tr> <tr> <td style="padding-bottom: 1.5pt; background-color: transparent; padding-left: 1.5pt; width: 12.08%; padding-right: 1.5pt; white-space: nowrap; padding-top: 1.5pt;border-color: #f0f0f0;" valign="top"> <p><span style="font-family: 新細明體,serif; font-size: 11pt;"><a href="http://dohlaw.doh.gov.tw/Chi/FLAW/FLAWDOC01.asp?lsid=FL013827&amp;lno=24"><span style="color: windowtext; text-decoration: none; text-underline: none;">第 &nbsp;&nbsp;24&nbsp;&nbsp;&nbsp;&nbsp; </span><span style="color: windowtext; text-decoration: none; text-underline: none;">條</span></a> </span></p> </td> <td style="padding-bottom: 1.5pt; background-color: transparent; padding-left: 1.5pt; width: 86.86%; padding-right: 1.5pt; padding-top: 1.5pt;border-color: #f0f0f0;"> <p><span style="font-family: 細明體; font-size: 11pt;">清潔方法之確效應能確實證明清潔過程之有效性。 </span></p> </td> </tr> <tr> <td style="padding-bottom: 1.5pt; background-color: transparent; padding-left: 1.5pt; width: 12.08%; padding-right: 1.5pt; white-space: nowrap; padding-top: 1.5pt;border-color: #f0f0f0;" valign="top"> <p><span style="font-family: 新細明體,serif; font-size: 11pt;"><a href="http://dohlaw.doh.gov.tw/Chi/FLAW/FLAWDOC01.asp?lsid=FL013827&amp;lno=25"><span style="color: windowtext; text-decoration: none; text-underline: none;">第 &nbsp;&nbsp;25&nbsp;&nbsp;&nbsp;&nbsp; </span><span style="color: windowtext; text-decoration: none; text-underline: none;">條</span></a> </span></p> </td> <td style="padding-bottom: 1.5pt; background-color: transparent; padding-left: 1.5pt; width: 86.86%; padding-right: 1.5pt; padding-top: 1.5pt;border-color: #f0f0f0;"> <p><span style="font-family: 細明體; font-size: 11pt;">確效作業應得藉由直接表面取樣或洗滌取樣等適當之採樣法行之。 </span></p> </td> </tr> <tr> <td style="padding-bottom: 1.5pt; background-color: transparent; padding-left: 1.5pt; width: 12.08%; padding-right: 1.5pt; white-space: nowrap; padding-top: 1.5pt;border-color: #f0f0f0;" valign="top"> <p><span style="font-family: 新細明體,serif; font-size: 11pt;"><a href="http://dohlaw.doh.gov.tw/Chi/FLAW/FLAWDOC01.asp?lsid=FL013827&amp;lno=26"><span style="color: windowtext; text-decoration: none; text-underline: none;">第 &nbsp;&nbsp;26&nbsp;&nbsp;&nbsp;&nbsp; </span><span style="color: windowtext; text-decoration: none; text-underline: none;">條</span></a> </span></p> </td> <td style="padding-bottom: 1.5pt; background-color: transparent; padding-left: 1.5pt; width: 86.86%; padding-right: 1.5pt; padding-top: 1.5pt;border-color: #f0f0f0;"> <p><span style="font-family: 細明體; font-size: 11pt;">確效作業時，檢體之分析方法應具備專一性及適當之靈敏度。分析之目標 </span></p> <p><span style="font-family: 細明體; font-size: 11pt;">應以檢測殘留物或污染物為準。 </span></p> </td> </tr> <tr> <td style="padding-bottom: 1.5pt; background-color: transparent; padding-left: 1.5pt; width: 12.08%; padding-right: 1.5pt; white-space: nowrap; padding-top: 1.5pt;border-color: #f0f0f0;" valign="top"> <p><span style="font-family: 新細明體,serif; font-size: 11pt;"><a href="http://dohlaw.doh.gov.tw/Chi/FLAW/FLAWDOC01.asp?lsid=FL013827&amp;lno=27"><span style="color: windowtext; text-decoration: none; text-underline: none;">第 &nbsp;&nbsp;27&nbsp;&nbsp;&nbsp;&nbsp; </span><span style="color: windowtext; text-decoration: none; text-underline: none;">條</span></a> </span></p> </td> <td style="padding-bottom: 1.5pt; background-color: transparent; padding-left: 1.5pt; width: 86.86%; padding-right: 1.5pt; padding-top: 1.5pt;border-color: #f0f0f0;"> <p><span style="font-family: 細明體; font-size: 11pt;">清潔方法經確效後，得用間接測試方法如導電度法作線上長期監控。任何 </span></p> <p><span style="font-family: 細明體; font-size: 11pt;">間接檢測方法必須輔以設備狀況之相關資料。每次確效時應將間接檢測之 </span></p> <p><span style="font-family: 細明體; font-size: 11pt;">書面記錄列為參考資料。 </span></p> </td> </tr> <tr> <td style="padding-bottom: 1.5pt; background-color: transparent; padding-left: 1.5pt; width: 12.08%; padding-right: 1.5pt; white-space: nowrap; padding-top: 1.5pt;border-color: #f0f0f0;" valign="top"> <p><span style="font-family: 新細明體,serif; font-size: 11pt;"><a href="http://dohlaw.doh.gov.tw/Chi/FLAW/FLAWDOC01.asp?lsid=FL013827&amp;lno=28"><span style="color: windowtext; text-decoration: none; text-underline: none;">第 &nbsp;&nbsp;28&nbsp;&nbsp;&nbsp;&nbsp; </span><span style="color: windowtext; text-decoration: none; text-underline: none;">條</span></a> </span></p> </td> <td style="padding-bottom: 1.5pt; background-color: transparent; padding-left: 1.5pt; width: 86.86%; padding-right: 1.5pt; padding-top: 1.5pt;border-color: #f0f0f0;"> <p><span style="font-family: 細明體; font-size: 11pt;">確效作業之結果必須彙集成檔。經過批准的確效報告中應書明所確效之清 </span></p> <p><span style="font-family: 細明體; font-size: 11pt;">潔方法是否符合確效標準，並以科學數據證明有關符合既訂標準之推判。 </span></p> </td> </tr> <tr> <td style="padding-bottom: 1.5pt; background-color: transparent; padding-left: 1.5pt; width: 12.08%; padding-right: 1.5pt; white-space: nowrap; padding-top: 1.5pt;border-color: #f0f0f0;" valign="top"> <p><span style="font-family: 新細明體,serif; font-size: 11pt;"><a href="http://dohlaw.doh.gov.tw/Chi/FLAW/FLAWDOC01.asp?lsid=FL013827&amp;lno=29"><span style="color: windowtext; text-decoration: none; text-underline: none;">第 &nbsp;&nbsp;29&nbsp;&nbsp;&nbsp;&nbsp; </span><span style="color: windowtext; text-decoration: none; text-underline: none;">條</span></a> </span></p> </td> <td style="padding-bottom: 1.5pt; background-color: transparent; padding-left: 1.5pt; width: 86.86%; padding-right: 1.5pt; padding-top: 1.5pt;border-color: #f0f0f0;"> <p><span style="font-family: 細明體; font-size: 11pt;">鑑於設備與產品的變異範圍巨大，本基準不設定統一之規格或方法供決定 </span></p> <p><span style="font-family: 細明體; font-size: 11pt;">清潔方法是否有效。各藥廠應依本身所有之設備及製劑之特性、藥品原料 </span></p> <p><span style="font-family: 細明體; font-size: 11pt;">及賦形劑之本質、清潔劑之物理化學性質及毒性、與化學分析法之靈敏度 </span></p> <p><span style="font-family: 細明體; font-size: 11pt;">等，分別基於科學背景而適當制訂之。 </span></p> </td> </tr> <tr> <td style="padding-bottom: 1.5pt; background-color: transparent; padding-left: 1.5pt; width: 99.3%; padding-right: 1.5pt; padding-top: 1.5pt;border-color: #f0f0f0;" colspan="2"> <p><b><span style="font-family: 新細明體,serif; font-size: 11pt;">&nbsp;&nbsp;&nbsp;</span></b><b><span style="font-family: 新細明體,serif; font-size: 11pt;">第&nbsp;三&nbsp;章&nbsp;純化水系統之確效</span></b> </p> </td> </tr> <tr> <td style="padding-bottom: 1.5pt; background-color: transparent; padding-left: 1.5pt; width: 12.08%; padding-right: 1.5pt; white-space: nowrap; padding-top: 1.5pt;border-color: #f0f0f0;" valign="top"> <p><span style="font-family: 新細明體,serif; font-size: 11pt;"><a href="http://dohlaw.doh.gov.tw/Chi/FLAW/FLAWDOC01.asp?lsid=FL013827&amp;lno=30"><span style="color: windowtext; text-decoration: none; text-underline: none;">第 &nbsp;&nbsp;30&nbsp;&nbsp;&nbsp;&nbsp; </span><span style="color: windowtext; text-decoration: none; text-underline: none;">條</span></a> </span></p> </td> <td style="padding-bottom: 1.5pt; background-color: transparent; padding-left: 1.5pt; width: 86.86%; padding-right: 1.5pt; padding-top: 1.5pt;border-color: #f0f0f0;"> <p><span style="font-family: 細明體; font-size: 11pt;">本章所稱純化水處理系統，係指藥廠內為製造各種高純度純化水 (含純淨 </span></p> <p><span style="font-family: 細明體; font-size: 11pt;">水及注射用水) 供製藥作業使用之設備。一般用水及實驗室用水之製造不 </span></p> <p><span style="font-family: 細明體; font-size: 11pt;">在本基準規定範圍之內。 </span></p> </td> </tr> <tr> <td style="padding-bottom: 1.5pt; background-color: transparent; padding-left: 1.5pt; width: 12.08%; padding-right: 1.5pt; white-space: nowrap; padding-top: 1.5pt;border-color: #f0f0f0;" valign="top"> <p><span style="font-family: 新細明體,serif; font-size: 11pt;"><a href="http://dohlaw.doh.gov.tw/Chi/FLAW/FLAWDOC01.asp?lsid=FL013827&amp;lno=31"><span style="color: windowtext; text-decoration: none; text-underline: none;">第 &nbsp;&nbsp;31&nbsp;&nbsp;&nbsp;&nbsp; </span><span style="color: windowtext; text-decoration: none; text-underline: none;">條</span></a> </span></p> </td> <td style="padding-bottom: 1.5pt; background-color: transparent; padding-left: 1.5pt; width: 86.86%; padding-right: 1.5pt; padding-top: 1.5pt;border-color: #f0f0f0;"> <p><span style="font-family: 細明體; font-size: 11pt;">純化水處理系統應能持續穩定的供應既訂等級之純化水。純化水處理系統 </span></p> <p><span style="font-family: 細明體; font-size: 11pt;">之操作，應訂有標準作業程序以供遵循。每次操作應有書面紀錄記載系統 </span></p> <p><span style="font-family: 細明體; font-size: 11pt;">之運轉情況，各異常狀況，應逐一記錄，並報請權責單位人員處理，處理 </span></p> <p><span style="font-family: 細明體; font-size: 11pt;">情形亦應詳細記錄之。 </span></p> </td> </tr> <tr> <td style="padding-bottom: 1.5pt; background-color: transparent; padding-left: 1.5pt; width: 12.08%; padding-right: 1.5pt; white-space: nowrap; padding-top: 1.5pt;border-color: #f0f0f0;" valign="top"> <p><span style="font-family: 新細明體,serif; font-size: 11pt;"><a href="http://dohlaw.doh.gov.tw/Chi/FLAW/FLAWDOC01.asp?lsid=FL013827&amp;lno=32"><span style="color: windowtext; text-decoration: none; text-underline: none;">第 &nbsp;&nbsp;32&nbsp;&nbsp;&nbsp;&nbsp; </span><span style="color: windowtext; text-decoration: none; text-underline: none;">條</span></a> </span></p> </td> <td style="padding-bottom: 1.5pt; background-color: transparent; padding-left: 1.5pt; width: 86.86%; padding-right: 1.5pt; padding-top: 1.5pt;border-color: #f0f0f0;"> <p><span style="font-family: 細明體; font-size: 11pt;">藥廠應定期檢測純化水處理系統，驗證所製得之純化水是否合於既訂規格 </span></p> <p><span style="font-family: 細明體; font-size: 11pt;">，以供特定目的之用。為檢測純化水處理系統，應依藥品優良製造規範訂 </span></p> <p><span style="font-family: 細明體; font-size: 11pt;">有檢測之標準作業程序，據而執行。每次檢測後應將結果予以書面記錄。 </span></p> </td> </tr> <tr> <td style="padding-bottom: 1.5pt; background-color: transparent; padding-left: 1.5pt; width: 12.08%; padding-right: 1.5pt; white-space: nowrap; padding-top: 1.5pt;border-color: #f0f0f0;" valign="top"> <p><span style="font-family: 新細明體,serif; font-size: 11pt;"><a href="http://dohlaw.doh.gov.tw/Chi/FLAW/FLAWDOC01.asp?lsid=FL013827&amp;lno=33"><span style="color: windowtext; text-decoration: none; text-underline: none;">第 &nbsp;&nbsp;33&nbsp;&nbsp;&nbsp;&nbsp; </span><span style="color: windowtext; text-decoration: none; text-underline: none;">條</span></a> </span></p> </td> <td style="padding-bottom: 1.5pt; background-color: transparent; padding-left: 1.5pt; width: 86.86%; padding-right: 1.5pt; padding-top: 1.5pt;border-color: #f0f0f0;"> <p><span style="font-family: 細明體; font-size: 11pt;">純化水處理系統應以確效作業驗證其適當性。執行確效作業前應先擬具確 </span></p> <p><span style="font-family: 細明體; font-size: 11pt;">效計畫書，內容應包括取樣法、檢測方法、合格標準範圍等，經藥廠內權 </span></p> <p><span style="font-family: 細明體; font-size: 11pt;">責單位人員之核定後實施。 </span></p> </td> </tr> <tr> <td style="padding-bottom: 1.5pt; background-color: transparent; padding-left: 1.5pt; width: 12.08%; padding-right: 1.5pt; white-space: nowrap; padding-top: 1.5pt;border-color: #f0f0f0;" valign="top"> <p><span style="font-family: 新細明體,serif; font-size: 11pt;"><a href="http://dohlaw.doh.gov.tw/Chi/FLAW/FLAWDOC01.asp?lsid=FL013827&amp;lno=34"><span style="color: windowtext; text-decoration: none; text-underline: none;">第 &nbsp;&nbsp;34&nbsp;&nbsp;&nbsp;&nbsp; </span><span style="color: windowtext; text-decoration: none; text-underline: none;">條</span></a> </span></p> </td> <td style="padding-bottom: 1.5pt; background-color: transparent; padding-left: 1.5pt; width: 86.86%; padding-right: 1.5pt; padding-top: 1.5pt;border-color: #f0f0f0;"> <p><span style="font-family: 細明體; font-size: 11pt;">確效時應依核定之確效標準作業計畫，擬定確效標準作業程序，再據而進 </span></p> <p><span style="font-family: 細明體; font-size: 11pt;">行之；該標準作業程序上，應載有負責執行之單位及人員、確效作業之核 </span></p> <p><span style="font-family: 細明體; font-size: 11pt;">定、是否合格之判定標準及再確效日期。 </span></p> </td> </tr> <tr> <td style="padding-bottom: 1.5pt; background-color: transparent; padding-left: 1.5pt; width: 12.08%; padding-right: 1.5pt; white-space: nowrap; padding-top: 1.5pt;border-color: #f0f0f0;" valign="top"> <p><span style="font-family: 新細明體,serif; font-size: 11pt;"><a href="http://dohlaw.doh.gov.tw/Chi/FLAW/FLAWDOC01.asp?lsid=FL013827&amp;lno=35"><span style="color: windowtext; text-decoration: none; text-underline: none;">第 &nbsp;&nbsp;35&nbsp;&nbsp;&nbsp;&nbsp; </span><span style="color: windowtext; text-decoration: none; text-underline: none;">條</span></a> </span></p> </td> <td style="padding-bottom: 1.5pt; background-color: transparent; padding-left: 1.5pt; width: 86.86%; padding-right: 1.5pt; padding-top: 1.5pt;border-color: #f0f0f0;"> <p><span style="font-family: 細明體; font-size: 11pt;">純化水處理系統之確效範圍，包括系統在防制微生物污染以及可溶性及不 </span></p> <p><span style="font-family: 細明體; font-size: 11pt;">溶性雜質摻雜等之能力之評估。系統是否通過確效，除與所供之水質能合 </span></p> <p><span style="font-family: 細明體; font-size: 11pt;">乎各該適用之水質規格外，尚應包括系統是否能長期持續穩定供給合格之 </span></p> <p><span style="font-family: 細明體; font-size: 11pt;">純化水。 </span></p> </td> </tr> <tr> <td style="padding-bottom: 1.5pt; background-color: transparent; padding-left: 1.5pt; width: 12.08%; padding-right: 1.5pt; white-space: nowrap; padding-top: 1.5pt;border-color: #f0f0f0;" valign="top"> <p><span style="font-family: 新細明體,serif; font-size: 11pt;"><a href="http://dohlaw.doh.gov.tw/Chi/FLAW/FLAWDOC01.asp?lsid=FL013827&amp;lno=36"><span style="color: windowtext; text-decoration: none; text-underline: none;">第 &nbsp;&nbsp;36&nbsp;&nbsp;&nbsp;&nbsp; </span><span style="color: windowtext; text-decoration: none; text-underline: none;">條</span></a> </span></p> </td> <td style="padding-bottom: 1.5pt; background-color: transparent; padding-left: 1.5pt; width: 86.86%; padding-right: 1.5pt; padding-top: 1.5pt;border-color: #f0f0f0;"> <p><span style="font-family: 細明體; font-size: 11pt;">確效純化水處理系統時，得用適當之挑戰測試，但測試進行中，不得造成 </span></p> <p><span style="font-family: 細明體; font-size: 11pt;">系統之微生物污染。故應定期取樣測試微生物含量，並在系統之適當特定 </span></p> <p><span style="font-family: 細明體; font-size: 11pt;">位置安裝監測儀器，以確保系統之正常運轉。 </span></p> </td> </tr> <tr> <td style="padding-bottom: 1.5pt; background-color: transparent; padding-left: 1.5pt; width: 12.08%; padding-right: 1.5pt; white-space: nowrap; padding-top: 1.5pt;border-color: #f0f0f0;" valign="top"> <p><span style="font-family: 新細明體,serif; font-size: 11pt;"><a href="http://dohlaw.doh.gov.tw/Chi/FLAW/FLAWDOC01.asp?lsid=FL013827&amp;lno=37"><span style="color: windowtext; text-decoration: none; text-underline: none;">第 &nbsp;&nbsp;37&nbsp;&nbsp;&nbsp;&nbsp; </span><span style="color: windowtext; text-decoration: none; text-underline: none;">條</span></a> </span></p> </td> <td style="padding-bottom: 1.5pt; background-color: transparent; padding-left: 1.5pt; width: 86.86%; padding-right: 1.5pt; padding-top: 1.5pt;border-color: #f0f0f0;"> <p><span style="font-family: 細明體; font-size: 11pt;">確效純化水處理系統所須之書面資料，包括系統概要和系統流程圖。流程 </span></p> <p><span style="font-family: 細明體; font-size: 11pt;">圖之涵蓋範圍，應包括由採水點至使用點間之所有相關設備，並包括取樣 </span></p> <p><span style="font-family: 細明體; font-size: 11pt;">點。藥廠應隨時保持上列資料與實物之一致性，每年度並至少複核一次， </span></p> <p><span style="font-family: 細明體; font-size: 11pt;">以確保其正確性與所有變更設計的合理性。 </span></p> <p><span style="font-family: 細明體; font-size: 11pt;">本條所述各種資料，均應隨同確效作業所得數據及文字記述，彙總於確效 </span></p> <p><span style="font-family: 細明體; font-size: 11pt;">報告中。 </span></p> </td> </tr> <tr> <td style="padding-bottom: 1.5pt; background-color: transparent; padding-left: 1.5pt; width: 12.08%; padding-right: 1.5pt; white-space: nowrap; padding-top: 1.5pt;border-color: #f0f0f0;" valign="top"> <p><span style="font-family: 新細明體,serif; font-size: 11pt;"><a href="http://dohlaw.doh.gov.tw/Chi/FLAW/FLAWDOC01.asp?lsid=FL013827&amp;lno=38"><span style="color: windowtext; text-decoration: none; text-underline: none;">第</span><span style="color: windowtext; text-decoration: none; text-underline: none;"> &nbsp;&nbsp;38&nbsp;&nbsp;&nbsp;&nbsp; </span><span style="color: windowtext; text-decoration: none; text-underline: none;">條</span></a> </span></p> </td> <td style="padding-bottom: 1.5pt; background-color: transparent; padding-left: 1.5pt; width: 86.86%; padding-right: 1.5pt; padding-top: 1.5pt;border-color: #f0f0f0;"> <p><span style="font-family: 細明體; font-size: 11pt;">進行純化水確效作業前，應先依流程圖檢查所有系統和管路之正確性，然 </span></p> <p><span style="font-family: 細明體; font-size: 11pt;">後再開始確效，並依據既訂之操作條件、清潔消毒作業程序與頻率進行之 </span></p> <p><span style="font-family: 細明體; font-size: 11pt;">。 </span></p> </td> </tr> <tr> <td style="padding-bottom: 1.5pt; background-color: transparent; padding-left: 1.5pt; width: 12.08%; padding-right: 1.5pt; white-space: nowrap; padding-top: 1.5pt;border-color: #f0f0f0;" valign="top"> <p><span style="font-family: 新細明體,serif; font-size: 11pt;"><a href="http://dohlaw.doh.gov.tw/Chi/FLAW/FLAWDOC01.asp?lsid=FL013827&amp;lno=39"><span style="color: windowtext; text-decoration: none; text-underline: none;">第 &nbsp;&nbsp;39&nbsp;&nbsp;&nbsp;&nbsp; </span><span style="color: windowtext; text-decoration: none; text-underline: none;">條</span></a> </span></p> </td> <td style="padding-bottom: 1.5pt; background-color: transparent; padding-left: 1.5pt; width: 86.86%; padding-right: 1.5pt; padding-top: 1.5pt;border-color: #f0f0f0;"> <p><span style="font-family: 細明體; font-size: 11pt;">確效作業分三個階段： </span></p> <p><span style="font-family: 細明體; font-size: 11pt;">一&nbsp; 第一階段：每日在每個純化作業設計單元和每個使用點採樣檢驗，持 </span></p> <p><span style="font-family: 細明體; font-size: 11pt;">&nbsp;&nbsp;&nbsp; </span><span style="font-family: 細明體; font-size: 11pt;">續二至四個星期。在使用點採樣之作業，必須模擬正常取水作業，例 </span></p> <p><span style="font-family: 細明體; font-size: 11pt;">&nbsp;&nbsp;&nbsp; </span><span style="font-family: 細明體; font-size: 11pt;">如使用水管取水、取水前的沖洗水管作業。二至四個星期結束前，必 </span></p> <p><span style="font-family: 細明體; font-size: 11pt;">&nbsp;&nbsp;&nbsp; </span><span style="font-family: 細明體; font-size: 11pt;">須將純化水處理系統的確效標準作業程序編定完畢。 </span></p> <p><span style="font-family: 細明體; font-size: 11pt;">二&nbsp; 第二階段：驗證供水系統於正常操作條件下，可以穩定持續供應適當 </span></p> <p><span style="font-family: 細明體; font-size: 11pt;">&nbsp;&nbsp;&nbsp; </span><span style="font-family: 細明體; font-size: 11pt;">品質的水。確效的取樣方式與第一階段相同，包括所列之取樣點和期 </span></p> <p><span style="font-family: 細明體; font-size: 11pt;">&nbsp;&nbsp;&nbsp; </span><span style="font-family: 細明體; font-size: 11pt;">間。 </span></p> <p><span style="font-family: 細明體; font-size: 11pt;">三&nbsp; 第三階段：驗證該供水系統於正常操作條件下，使用長時間後，仍能 </span></p> <p><span style="font-family: 細明體; font-size: 11pt;">&nbsp;&nbsp;&nbsp; </span><span style="font-family: 細明體; font-size: 11pt;">穩定持續供應適當品質的純化水。確效作業必須包括原水水質的變異 </span></p> <p><span style="font-family: 細明體; font-size: 11pt;">&nbsp;&nbsp;&nbsp; </span><span style="font-family: 細明體; font-size: 11pt;">。取樣方式與第一階段相同；注射用水系統的取樣必須每天至少取一 </span></p> <p><span style="font-family: 細明體; font-size: 11pt;">&nbsp;&nbsp;&nbsp; </span><span style="font-family: 細明體; font-size: 11pt;">點，每週所有使用點均能被測試。當整年資料齊備後，確效即告完成 </span></p> <p><span style="font-family: 細明體; font-size: 11pt;">&nbsp;&nbsp;&nbsp; </span><span style="font-family: 細明體; font-size: 11pt;">。 </span></p> </td> </tr> <tr> <td style="padding-bottom: 1.5pt; background-color: transparent; padding-left: 1.5pt; width: 12.08%; padding-right: 1.5pt; white-space: nowrap; padding-top: 1.5pt;border-color: #f0f0f0;" valign="top"> <p><span style="font-family: 新細明體,serif; font-size: 11pt;"><a href="http://dohlaw.doh.gov.tw/Chi/FLAW/FLAWDOC01.asp?lsid=FL013827&amp;lno=40"><span style="color: windowtext; text-decoration: none; text-underline: none;">第 &nbsp;&nbsp;40&nbsp;&nbsp;&nbsp;&nbsp; </span><span style="color: windowtext; text-decoration: none; text-underline: none;">條</span></a> </span></p> </td> <td style="padding-bottom: 1.5pt; background-color: transparent; padding-left: 1.5pt; width: 86.86%; padding-right: 1.5pt; padding-top: 1.5pt;border-color: #f0f0f0;"> <p><span style="font-family: 細明體; font-size: 11pt;">以上階段性確效作業並非為唯一之確效方法，但其中已包括了對純化水處 </span></p> <p><span style="font-family: 細明體; font-size: 11pt;">理系統確效時應具備之項目。藥廠得以其他適當方法進行確效，但是除了 </span></p> <p><span style="font-family: 細明體; font-size: 11pt;">所採用之方法須具備科學基礎外，應符合下列各點： </span></p> <p><span style="font-family: 細明體; font-size: 11pt;">一&nbsp; 備有充足之資料，以支持確效標準作業程序之適當性。 </span></p> <p><span style="font-family: 細明體; font-size: 11pt;">二&nbsp; 備有適當之數據資料，以證明該確效標準作業程序具有效性，並能持 </span></p> <p><span style="font-family: 細明體; font-size: 11pt;">&nbsp;&nbsp;&nbsp; </span><span style="font-family: 細明體; font-size: 11pt;">續製出符合既訂標準的純化水。 </span></p> <p><span style="font-family: 細明體; font-size: 11pt;">三&nbsp; 備有適當之資料以證明週期性的原水水質差異，不會影響供水系統之 </span></p> <p><span style="font-family: 細明體; font-size: 11pt;">&nbsp;&nbsp;&nbsp; </span><span style="font-family: 細明體; font-size: 11pt;">作業及所製出之水質。 </span></p> </td> </tr> <tr> <td style="padding-bottom: 1.5pt; background-color: transparent; padding-left: 1.5pt; width: 12.08%; padding-right: 1.5pt; white-space: nowrap; padding-top: 1.5pt;border-color: #f0f0f0;" valign="top"> <p><span style="font-family: 新細明體,serif; font-size: 11pt;"><a href="http://dohlaw.doh.gov.tw/Chi/FLAW/FLAWDOC01.asp?lsid=FL013827&amp;lno=41"><span style="color: windowtext; text-decoration: none; text-underline: none;">第 &nbsp;&nbsp;41&nbsp;&nbsp;&nbsp;&nbsp; </span><span style="color: windowtext; text-decoration: none; text-underline: none;">條</span></a> </span></p> </td> <td style="padding-bottom: 1.5pt; background-color: transparent; padding-left: 1.5pt; width: 86.86%; padding-right: 1.5pt; padding-top: 1.5pt;border-color: #f0f0f0;"> <p><span style="font-family: 細明體; font-size: 11pt;">確效作業時所涉及之微生物試驗、各種水質檢驗之操作及各相關規格，悉 </span></p> <p><span style="font-family: 細明體; font-size: 11pt;">依各該事項之檢驗法、規格及有關之確效規定處理之。 </span></p> </td> </tr> <tr> <td style="padding-bottom: 1.5pt; background-color: transparent; padding-left: 1.5pt; width: 12.08%; padding-right: 1.5pt; white-space: nowrap; padding-top: 1.5pt;border-color: #f0f0f0;" valign="top"> <p><span style="font-family: 新細明體,serif; font-size: 11pt;"><a href="http://dohlaw.doh.gov.tw/Chi/FLAW/FLAWDOC01.asp?lsid=FL013827&amp;lno=42"><span style="color: windowtext; text-decoration: none; text-underline: none;">第 &nbsp;&nbsp;42&nbsp;&nbsp;&nbsp;&nbsp; </span><span style="color: windowtext; text-decoration: none; text-underline: none;">條</span></a> </span></p> </td> <td style="padding-bottom: 1.5pt; background-color: transparent; padding-left: 1.5pt; width: 86.86%; padding-right: 1.5pt; padding-top: 1.5pt;border-color: #f0f0f0;"> <p><span style="font-family: 細明體; font-size: 11pt;">完成確效後，應將所得資料彙總並作總結報告，該報告必須有純化水處理 </span></p> <p><span style="font-family: 細明體; font-size: 11pt;">系統操作單位和品質管理單位主管之簽核。 </span></p> </td> </tr> <tr> <td style="padding-bottom: 1.5pt; background-color: transparent; padding-left: 1.5pt; width: 99.3%; padding-right: 1.5pt; padding-top: 1.5pt;border-color: #f0f0f0;" colspan="2"> <p><b><span style="font-family: 新細明體,serif; font-size: 11pt;">&nbsp;&nbsp;&nbsp;</span></b><b><span style="font-family: 新細明體,serif; font-size: 11pt;">第&nbsp;四&nbsp;章&nbsp;空氣調節系統之確效</span></b> </p> </td> </tr> <tr> <td style="padding-bottom: 1.5pt; background-color: transparent; padding-left: 1.5pt; width: 12.08%; padding-right: 1.5pt; white-space: nowrap; padding-top: 1.5pt;border-color: #f0f0f0;" valign="top"> <p><span style="font-family: 新細明體,serif; font-size: 11pt;"><a href="http://dohlaw.doh.gov.tw/Chi/FLAW/FLAWDOC01.asp?lsid=FL013827&amp;lno=43"><span style="color: windowtext; text-decoration: none; text-underline: none;">第 &nbsp;&nbsp;43&nbsp;&nbsp;&nbsp;&nbsp; </span><span style="color: windowtext; text-decoration: none; text-underline: none;">條</span></a> </span></p> </td> <td style="padding-bottom: 1.5pt; background-color: transparent; padding-left: 1.5pt; width: 86.86%; padding-right: 1.5pt; padding-top: 1.5pt;border-color: #f0f0f0;"> <p><span style="font-family: 細明體; font-size: 11pt;">本章所指之空氣調節系統係指用於調節作業場所之溫度及濕度，並去除或 </span></p> <p><span style="font-family: 細明體; font-size: 11pt;">阻隔微粒物質與微生物等污染源之設施。 </span></p> </td> </tr> <tr> <td style="padding-bottom: 1.5pt; background-color: transparent; padding-left: 1.5pt; width: 12.08%; padding-right: 1.5pt; white-space: nowrap; padding-top: 1.5pt;border-color: #f0f0f0;" valign="top"> <p><span style="font-family: 新細明體,serif; font-size: 11pt;"><a href="http://dohlaw.doh.gov.tw/Chi/FLAW/FLAWDOC01.asp?lsid=FL013827&amp;lno=44"><span style="color: windowtext; text-decoration: none; text-underline: none;">第 &nbsp;&nbsp;44&nbsp;&nbsp;&nbsp;&nbsp; </span><span style="color: windowtext; text-decoration: none; text-underline: none;">條</span></a> </span></p> </td> <td style="padding-bottom: 1.5pt; background-color: transparent; padding-left: 1.5pt; width: 86.86%; padding-right: 1.5pt; padding-top: 1.5pt;border-color: #f0f0f0;"> <p><span style="font-family: 細明體; font-size: 11pt;">確效空氣調節系統之目的在於確定該系統能持續穩定的控制作業場所之空 </span></p> <p><span style="font-family: 細明體; font-size: 11pt;">氣品質，俾使製成之藥品能維持於既訂之品質且不受污染。 </span></p> </td> </tr> <tr> <td style="padding-bottom: 1.5pt; background-color: transparent; padding-left: 1.5pt; width: 12.08%; padding-right: 1.5pt; white-space: nowrap; padding-top: 1.5pt;border-color: #f0f0f0;" valign="top"> <p><span style="font-family: 新細明體,serif; font-size: 11pt;"><a href="http://dohlaw.doh.gov.tw/Chi/FLAW/FLAWDOC01.asp?lsid=FL013827&amp;lno=45"><span style="color: windowtext; text-decoration: none; text-underline: none;">第 &nbsp;&nbsp;45&nbsp;&nbsp;&nbsp;&nbsp; </span><span style="color: windowtext; text-decoration: none; text-underline: none;">條</span></a> </span></p> </td> <td style="padding-bottom: 1.5pt; background-color: transparent; padding-left: 1.5pt; width: 86.86%; padding-right: 1.5pt; padding-top: 1.5pt;border-color: #f0f0f0;"> <p><span style="font-family: 細明體; font-size: 11pt;">藥廠應於空氣調節系統訂有定期維護及確效措施，並按計畫實施。 </span></p> </td> </tr> <tr> <td style="padding-bottom: 1.5pt; background-color: transparent; padding-left: 1.5pt; width: 12.08%; padding-right: 1.5pt; white-space: nowrap; padding-top: 1.5pt;border-color: #f0f0f0;" valign="top"> <p><span style="font-family: 新細明體,serif; font-size: 11pt;"><a href="http://dohlaw.doh.gov.tw/Chi/FLAW/FLAWDOC01.asp?lsid=FL013827&amp;lno=46"><span style="color: windowtext; text-decoration: none; text-underline: none;">第 &nbsp;&nbsp;46&nbsp;&nbsp;&nbsp;&nbsp; </span><span style="color: windowtext; text-decoration: none; text-underline: none;">條</span></a> </span></p> </td> <td style="padding-bottom: 1.5pt; background-color: transparent; padding-left: 1.5pt; width: 86.86%; padding-right: 1.5pt; padding-top: 1.5pt;border-color: #f0f0f0;"> <p><span style="font-family: 細明體; font-size: 11pt;">空氣調節系統確效計畫書中應配備有空氣調節系統之管線配置圖，圖中明 </span></p> <p><span style="font-family: 細明體; font-size: 11pt;">示管線之位置及空氣流向、各濾器之位置、空調開關位置、各場所之進風 </span></p> <p><span style="font-family: 細明體; font-size: 11pt;">口及出風口位置等。 </span></p> </td> </tr> <tr> <td style="padding-bottom: 1.5pt; background-color: transparent; padding-left: 1.5pt; width: 12.08%; padding-right: 1.5pt; white-space: nowrap; padding-top: 1.5pt;border-color: #f0f0f0;" valign="top"> <p><span style="font-family: 新細明體,serif; font-size: 11pt;"><a href="http://dohlaw.doh.gov.tw/Chi/FLAW/FLAWDOC01.asp?lsid=FL013827&amp;lno=47"><span style="color: windowtext; text-decoration: none; text-underline: none;">第 &nbsp;&nbsp;47&nbsp;&nbsp;&nbsp;&nbsp; </span><span style="color: windowtext; text-decoration: none; text-underline: none;">條</span></a> </span></p> </td> <td style="padding-bottom: 1.5pt; background-color: transparent; padding-left: 1.5pt; width: 86.86%; padding-right: 1.5pt; padding-top: 1.5pt;border-color: #f0f0f0;"> <p><span style="font-family: 細明體; font-size: 11pt;">空氣調節系統之確效包括下列各項之驗證： </span></p> <p><span style="font-family: 細明體; font-size: 11pt;">一&nbsp; 溫度。 </span></p> <p><span style="font-family: 細明體; font-size: 11pt;">二&nbsp; 濕度。 </span></p> <p><span style="font-family: 細明體; font-size: 11pt;">三&nbsp; 風量。 </span></p> <p><span style="font-family: 細明體; font-size: 11pt;">四&nbsp; 換氣數。 </span></p> <p><span style="font-family: 細明體; font-size: 11pt;">五&nbsp; 風速。 </span></p> <p><span style="font-family: 細明體; font-size: 11pt;">六&nbsp; 壓差。 </span></p> <p><span style="font-family: 細明體; font-size: 11pt;">七&nbsp; 過濾效率。 </span></p> </td> </tr> <tr> <td style="padding-bottom: 1.5pt; background-color: transparent; padding-left: 1.5pt; width: 12.08%; padding-right: 1.5pt; white-space: nowrap; padding-top: 1.5pt;border-color: #f0f0f0;" valign="top"> <p><span style="font-family: 新細明體,serif; font-size: 11pt;"><a href="http://dohlaw.doh.gov.tw/Chi/FLAW/FLAWDOC01.asp?lsid=FL013827&amp;lno=48"><span style="color: windowtext; text-decoration: none; text-underline: none;">第 &nbsp;&nbsp;48&nbsp;&nbsp;&nbsp;&nbsp; </span><span style="color: windowtext; text-decoration: none; text-underline: none;">條</span></a> </span></p> </td> <td style="padding-bottom: 1.5pt; background-color: transparent; padding-left: 1.5pt; width: 86.86%; padding-right: 1.5pt; padding-top: 1.5pt;border-color: #f0f0f0;"> <p><span style="font-family: 細明體; font-size: 11pt;">溫度控制之驗證應以經過校正之溫度計記錄之，亦得以校正過之自動記錄 </span></p> <p><span style="font-family: 細明體; font-size: 11pt;">器連續記錄。 </span></p> </td> </tr> <tr> <td style="padding-bottom: 1.5pt; background-color: transparent; padding-left: 1.5pt; width: 12.08%; padding-right: 1.5pt; white-space: nowrap; padding-top: 1.5pt;border-color: #f0f0f0;" valign="top"> <p><span style="font-family: 新細明體,serif; font-size: 11pt;"><a href="http://dohlaw.doh.gov.tw/Chi/FLAW/FLAWDOC01.asp?lsid=FL013827&amp;lno=49"><span style="color: windowtext; text-decoration: none; text-underline: none;">第 &nbsp;&nbsp;49&nbsp;&nbsp;&nbsp;&nbsp; </span><span style="color: windowtext; text-decoration: none; text-underline: none;">條</span></a> </span></p> </td> <td style="padding-bottom: 1.5pt; background-color: transparent; padding-left: 1.5pt; width: 86.86%; padding-right: 1.5pt; padding-top: 1.5pt;border-color: #f0f0f0;"> <p><span style="font-family: 細明體; font-size: 11pt;">濕度控制之驗證得以校正過之自動記錄器記錄之。 </span></p> </td> </tr> <tr> <td style="padding-bottom: 1.5pt; background-color: transparent; padding-left: 1.5pt; width: 12.08%; padding-right: 1.5pt; white-space: nowrap; padding-top: 1.5pt;border-color: #f0f0f0;" valign="top"> <p><span style="font-family: 新細明體,serif; font-size: 11pt;"><a href="http://dohlaw.doh.gov.tw/Chi/FLAW/FLAWDOC01.asp?lsid=FL013827&amp;lno=50"><span style="color: windowtext; text-decoration: none; text-underline: none;">第 &nbsp;&nbsp;50&nbsp;&nbsp;&nbsp;&nbsp; </span><span style="color: windowtext; text-decoration: none; text-underline: none;">條</span></a> </span></p> </td> <td style="padding-bottom: 1.5pt; background-color: transparent; padding-left: 1.5pt; width: 86.86%; padding-right: 1.5pt; padding-top: 1.5pt;border-color: #f0f0f0;"> <p><span style="font-family: 細明體; font-size: 11pt;">風量控制之驗證得在進風口與出風口處以校正過之風量計或風速計測量。 </span></p> </td> </tr> <tr> <td style="padding-bottom: 1.5pt; background-color: transparent; padding-left: 1.5pt; width: 12.08%; padding-right: 1.5pt; white-space: nowrap; padding-top: 1.5pt;border-color: #f0f0f0;" valign="top"> <p><span style="font-family: 新細明體,serif; font-size: 11pt;"><a href="http://dohlaw.doh.gov.tw/Chi/FLAW/FLAWDOC01.asp?lsid=FL013827&amp;lno=51"><span style="color: windowtext; text-decoration: none; text-underline: none;">第 &nbsp;&nbsp;51&nbsp;&nbsp;&nbsp;&nbsp; </span><span style="color: windowtext; text-decoration: none; text-underline: none;">條</span></a> </span></p> </td> <td style="padding-bottom: 1.5pt; background-color: transparent; padding-left: 1.5pt; width: 86.86%; padding-right: 1.5pt; padding-top: 1.5pt;border-color: #f0f0f0;"> <p><span style="font-family: 細明體; font-size: 11pt;">層流設備之風速驗證，得以校正過之風量計或風速計測量之。 </span></p> </td> </tr> <tr> <td style="padding-bottom: 1.5pt; background-color: transparent; padding-left: 1.5pt; width: 12.08%; padding-right: 1.5pt; white-space: nowrap; padding-top: 1.5pt;border-color: #f0f0f0;" valign="top"> <p><span style="font-family: 新細明體,serif; font-size: 11pt;"><a href="http://dohlaw.doh.gov.tw/Chi/FLAW/FLAWDOC01.asp?lsid=FL013827&amp;lno=52"><span style="color: windowtext; text-decoration: none; text-underline: none;">第 &nbsp;&nbsp;52&nbsp;&nbsp;&nbsp;&nbsp; </span><span style="color: windowtext; text-decoration: none; text-underline: none;">條</span></a> </span></p> </td> <td style="padding-bottom: 1.5pt; background-color: transparent; padding-left: 1.5pt; width: 86.86%; padding-right: 1.5pt; padding-top: 1.5pt;border-color: #f0f0f0;"> <p><span style="font-family: 細明體; font-size: 11pt;">壓差之驗證得以適當方法行之。 </span></p> </td> </tr> <tr> <td style="padding-bottom: 1.5pt; background-color: transparent; padding-left: 1.5pt; width: 12.08%; padding-right: 1.5pt; white-space: nowrap; padding-top: 1.5pt;border-color: #f0f0f0;" valign="top"> <p><span style="font-family: 新細明體,serif; font-size: 11pt;"><a href="http://dohlaw.doh.gov.tw/Chi/FLAW/FLAWDOC01.asp?lsid=FL013827&amp;lno=53"><span style="color: windowtext; text-decoration: none; text-underline: none;">第 &nbsp;&nbsp;53&nbsp;&nbsp;&nbsp;&nbsp; </span><span style="color: windowtext; text-decoration: none; text-underline: none;">條</span></a> </span></p> </td> <td style="padding-bottom: 1.5pt; background-color: transparent; padding-left: 1.5pt; width: 86.86%; padding-right: 1.5pt; padding-top: 1.5pt;border-color: #f0f0f0;"> <p><span style="font-family: 細明體; font-size: 11pt;">必要時 (如無菌製劑) 宜將作業場所內之空氣流動型態之測試納入確效作 </span></p> <p><span style="font-family: 細明體; font-size: 11pt;">業。 </span></p> </td> </tr> <tr> <td style="padding-bottom: 1.5pt; background-color: transparent; padding-left: 1.5pt; width: 12.08%; padding-right: 1.5pt; white-space: nowrap; padding-top: 1.5pt;border-color: #f0f0f0;" valign="top"> <p><span style="font-family: 新細明體,serif; font-size: 11pt;"><a href="http://dohlaw.doh.gov.tw/Chi/FLAW/FLAWDOC01.asp?lsid=FL013827&amp;lno=54"><span style="color: windowtext; text-decoration: none; text-underline: none;">第 &nbsp;&nbsp;54&nbsp;&nbsp;&nbsp;&nbsp; </span><span style="color: windowtext; text-decoration: none; text-underline: none;">條</span></a> </span></p> </td> <td style="padding-bottom: 1.5pt; background-color: transparent; padding-left: 1.5pt; width: 86.86%; padding-right: 1.5pt; padding-top: 1.5pt;border-color: #f0f0f0;"> <p><span style="font-family: 細明體; font-size: 11pt;">過濾效率之驗證對象為高效率空氣過濾器，得以適當方法行之。 </span></p> </td> </tr> <tr> <td style="padding-bottom: 1.5pt; background-color: transparent; padding-left: 1.5pt; width: 12.08%; padding-right: 1.5pt; white-space: nowrap; padding-top: 1.5pt;border-color: #f0f0f0;" valign="top"> <p><span style="font-family: 新細明體,serif; font-size: 11pt;"><a href="http://dohlaw.doh.gov.tw/Chi/FLAW/FLAWDOC01.asp?lsid=FL013827&amp;lno=55"><span style="color: windowtext; text-decoration: none; text-underline: none;">第 &nbsp;&nbsp;55&nbsp;&nbsp;&nbsp;&nbsp; </span><span style="color: windowtext; text-decoration: none; text-underline: none;">條</span></a> </span></p> </td> <td style="padding-bottom: 1.5pt; background-color: transparent; padding-left: 1.5pt; width: 86.86%; padding-right: 1.5pt; padding-top: 1.5pt;border-color: #f0f0f0;"> <p><span style="font-family: 細明體; font-size: 11pt;">環境之監控應包括測定空氣中所含之微粒物質與設備、設施表面及空氣中 </span></p> <p><span style="font-family: 細明體; font-size: 11pt;">之微生物，以及無菌作業場所之人員可能造成之污染。微粒物質得用適當 </span></p> <p><span style="font-family: 細明體; font-size: 11pt;">之微粒計數器測定之，生菌數得用落菌法、空氣取樣法或表面擦拭取樣法 </span></p> <p><span style="font-family: 細明體; font-size: 11pt;">測定之。測定時應分別於該環境之使用中及非使用中進行。 </span></p> </td> </tr> <tr> <td style="padding-bottom: 1.5pt; background-color: transparent; padding-left: 1.5pt; width: 12.08%; padding-right: 1.5pt; white-space: nowrap; padding-top: 1.5pt;border-color: #f0f0f0;" valign="top"> <p><span style="font-family: 新細明體,serif; font-size: 11pt;"><a href="http://dohlaw.doh.gov.tw/Chi/FLAW/FLAWDOC01.asp?lsid=FL013827&amp;lno=56"><span style="color: windowtext; text-decoration: none; text-underline: none;">第 &nbsp;&nbsp;56&nbsp;&nbsp;&nbsp;&nbsp; </span><span style="color: windowtext; text-decoration: none; text-underline: none;">條</span></a> </span></p> </td> <td style="padding-bottom: 1.5pt; background-color: transparent; padding-left: 1.5pt; width: 86.86%; padding-right: 1.5pt; padding-top: 1.5pt;border-color: #f0f0f0;"> <p><span style="font-family: 細明體; font-size: 11pt;">為利於第四十八條至第五十五條所列之各項運作，空調設施上之適當部位 </span></p> <p><span style="font-family: 細明體; font-size: 11pt;">及空調室內，應備有取樣點以供安裝各測量儀器為原則。 </span></p> </td> </tr> <tr> <td style="padding-bottom: 1.5pt; background-color: transparent; padding-left: 1.5pt; width: 12.08%; padding-right: 1.5pt; white-space: nowrap; padding-top: 1.5pt;border-color: #f0f0f0;" valign="top"> <p><span style="font-family: 新細明體,serif; font-size: 11pt;"><a href="http://dohlaw.doh.gov.tw/Chi/FLAW/FLAWDOC01.asp?lsid=FL013827&amp;lno=57"><span style="color: windowtext; text-decoration: none; text-underline: none;">第 &nbsp;&nbsp;57&nbsp;&nbsp;&nbsp;&nbsp; </span><span style="color: windowtext; text-decoration: none; text-underline: none;">條</span></a> </span></p> </td> <td style="padding-bottom: 1.5pt; background-color: transparent; padding-left: 1.5pt; width: 86.86%; padding-right: 1.5pt; padding-top: 1.5pt;border-color: #f0f0f0;"> <p><span style="font-family: 細明體; font-size: 11pt;">空氣調節系統之確效頻率應依藥廠所在地之環境而定，至少每年一次。 </span></p> </td> </tr> <tr> <td style="padding-bottom: 1.5pt; background-color: transparent; padding-left: 1.5pt; width: 12.08%; padding-right: 1.5pt; white-space: nowrap; padding-top: 1.5pt;border-color: #f0f0f0;" valign="top"> <p><span style="font-family: 新細明體,serif; font-size: 11pt;"><a href="http://dohlaw.doh.gov.tw/Chi/FLAW/FLAWDOC01.asp?lsid=FL013827&amp;lno=58"><span style="color: windowtext; text-decoration: none; text-underline: none;">第 &nbsp;&nbsp;58&nbsp;&nbsp;&nbsp;&nbsp; </span><span style="color: windowtext; text-decoration: none; text-underline: none;">條</span></a> </span></p> </td> <td style="padding-bottom: 1.5pt; background-color: transparent; padding-left: 1.5pt; width: 86.86%; padding-right: 1.5pt; padding-top: 1.5pt;border-color: #f0f0f0;"> <p><span style="font-family: 細明體; font-size: 11pt;">空氣調節系統之確效數據應彙整成檔，送權責單位核定。確效時如發現有 </span></p> <p><span style="font-family: 細明體; font-size: 11pt;">異常現象，應立即處理改善；如為污染有關事宜，應即停止有關之製造工 </span></p> <p><span style="font-family: 細明體; font-size: 11pt;">作，迄改善後再復工。異常現象均應納入檔案以便追蹤檢討。 </span></p> </td> </tr> <tr> <td style="padding-bottom: 1.5pt; background-color: transparent; padding-left: 1.5pt; width: 99.3%; padding-right: 1.5pt; padding-top: 1.5pt;border-color: #f0f0f0;" colspan="2"> <p><b><span style="font-family: 新細明體,serif; font-size: 11pt;">第&nbsp;三&nbsp;編&nbsp;人員</span></b> </p> </td> </tr> <tr> <td style="padding-bottom: 1.5pt; background-color: transparent; padding-left: 1.5pt; width: 12.08%; padding-right: 1.5pt; white-space: nowrap; padding-top: 1.5pt;border-color: #f0f0f0;" valign="top"> <p><span style="font-family: 新細明體,serif; font-size: 11pt;"><a href="http://dohlaw.doh.gov.tw/Chi/FLAW/FLAWDOC01.asp?lsid=FL013827&amp;lno=59"><span style="color: windowtext; text-decoration: none; text-underline: none;">第 &nbsp;&nbsp;59&nbsp;&nbsp;&nbsp;&nbsp; </span><span style="color: windowtext; text-decoration: none; text-underline: none;">條</span></a> </span></p> </td> <td style="padding-bottom: 1.5pt; background-color: transparent; padding-left: 1.5pt; width: 86.86%; padding-right: 1.5pt; padding-top: 1.5pt;border-color: #f0f0f0;"> <p><span style="font-family: 細明體; font-size: 11pt;">藥廠各部門應配置足夠之專業及作業人員以執行、督導每一成品之製造、 </span></p> <p><span style="font-family: 細明體; font-size: 11pt;">加工、包裝與儲存。此等人員參與指定工作之資格及能力應予確認。 </span></p> </td> </tr> <tr> <td style="padding-bottom: 1.5pt; background-color: transparent; padding-left: 1.5pt; width: 12.08%; padding-right: 1.5pt; white-space: nowrap; padding-top: 1.5pt;border-color: #f0f0f0;" valign="top"> <p><span style="font-family: 新細明體,serif; font-size: 11pt;"><a href="http://dohlaw.doh.gov.tw/Chi/FLAW/FLAWDOC01.asp?lsid=FL013827&amp;lno=60"><span style="color: windowtext; text-decoration: none; text-underline: none;">第 &nbsp;&nbsp;60&nbsp;&nbsp;&nbsp;&nbsp; </span><span style="color: windowtext; text-decoration: none; text-underline: none;">條</span></a> </span></p> </td> <td style="padding-bottom: 1.5pt; background-color: transparent; padding-left: 1.5pt; width: 86.86%; padding-right: 1.5pt; padding-top: 1.5pt;border-color: #f0f0f0;"> <p><span style="font-family: 細明體; font-size: 11pt;">本編所述之品質管理人員係品質管制及品質保證單位之技術及專業人員。 </span></p> </td> </tr> <tr> <td style="padding-bottom: 1.5pt; background-color: transparent; padding-left: 1.5pt; width: 12.08%; padding-right: 1.5pt; white-space: nowrap; padding-top: 1.5pt;border-color: #f0f0f0;" valign="top"> <p><span style="font-family: 新細明體,serif; font-size: 11pt;"><a href="http://dohlaw.doh.gov.tw/Chi/FLAW/FLAWDOC01.asp?lsid=FL013827&amp;lno=61"><span style="color: windowtext; text-decoration: none; text-underline: none;">第 &nbsp;&nbsp;61&nbsp;&nbsp;&nbsp;&nbsp; </span><span style="color: windowtext; text-decoration: none; text-underline: none;">條</span></a> </span></p> </td> <td style="padding-bottom: 1.5pt; background-color: transparent; padding-left: 1.5pt; width: 86.86%; padding-right: 1.5pt; padding-top: 1.5pt;border-color: #f0f0f0;"> <p><span style="font-family: 細明體; font-size: 11pt;">對於新進之專業與作業人員應訂有書面職前教育訓練計畫、教育內容及考 </span></p> <p><span style="font-family: 細明體; font-size: 11pt;">核辦法。對於不能通過考核之新進人員，亦應訂有加強教育及再考核之辦 </span></p> <p><span style="font-family: 細明體; font-size: 11pt;">法。 </span></p> </td> </tr> <tr> <td style="padding-bottom: 1.5pt; background-color: transparent; padding-left: 1.5pt; width: 12.08%; padding-right: 1.5pt; white-space: nowrap; padding-top: 1.5pt;border-color: #f0f0f0;" valign="top"> <p><span style="font-family: 新細明體,serif; font-size: 11pt;"><a href="http://dohlaw.doh.gov.tw/Chi/FLAW/FLAWDOC01.asp?lsid=FL013827&amp;lno=62"><span style="color: windowtext; text-decoration: none; text-underline: none;">第 &nbsp;&nbsp;62&nbsp;&nbsp;&nbsp;&nbsp; </span><span style="color: windowtext; text-decoration: none; text-underline: none;">條</span></a> </span></p> </td> <td style="padding-bottom: 1.5pt; background-color: transparent; padding-left: 1.5pt; width: 86.86%; padding-right: 1.5pt; padding-top: 1.5pt;border-color: #f0f0f0;"> <p><span style="font-family: 細明體; font-size: 11pt;">對於在職人員應訂有書面定期再教育之計畫、教育內容及考核辦法。 </span></p> </td> </tr> <tr> <td style="padding-bottom: 1.5pt; background-color: transparent; padding-left: 1.5pt; width: 12.08%; padding-right: 1.5pt; white-space: nowrap; padding-top: 1.5pt;border-color: #f0f0f0;" valign="top"> <p><span style="font-family: 新細明體,serif; font-size: 11pt;"><a href="http://dohlaw.doh.gov.tw/Chi/FLAW/FLAWDOC01.asp?lsid=FL013827&amp;lno=63"><span style="color: windowtext; text-decoration: none; text-underline: none;">第 &nbsp;&nbsp;63&nbsp;&nbsp;&nbsp;&nbsp; </span><span style="color: windowtext; text-decoration: none; text-underline: none;">條</span></a> </span></p> </td> <td style="padding-bottom: 1.5pt; background-color: transparent; padding-left: 1.5pt; width: 86.86%; padding-right: 1.5pt; padding-top: 1.5pt;border-color: #f0f0f0;"> <p><span style="font-family: 細明體; font-size: 11pt;">對於特殊作業 (如無菌作業) 之人員應訂有特定之教育訓練與考核辦法， </span></p> <p><span style="font-family: 細明體; font-size: 11pt;">合格後方可參加該項作業。對於專業人員應配合工作性質實施特定專長之 </span></p> <p><span style="font-family: 細明體; font-size: 11pt;">教育訓練與考核。 </span></p> </td> </tr> <tr> <td style="padding-bottom: 1.5pt; background-color: transparent; padding-left: 1.5pt; width: 12.08%; padding-right: 1.5pt; white-space: nowrap; padding-top: 1.5pt;border-color: #f0f0f0;" valign="top"> <p><span style="font-family: 新細明體,serif; font-size: 11pt;"><a href="http://dohlaw.doh.gov.tw/Chi/FLAW/FLAWDOC01.asp?lsid=FL013827&amp;lno=64"><span style="color: windowtext; text-decoration: none; text-underline: none;">第 &nbsp;&nbsp;64&nbsp;&nbsp;&nbsp;&nbsp; </span><span style="color: windowtext; text-decoration: none; text-underline: none;">條</span></a> </span></p> </td> <td style="padding-bottom: 1.5pt; background-color: transparent; padding-left: 1.5pt; width: 86.86%; padding-right: 1.5pt; padding-top: 1.5pt;border-color: #f0f0f0;"> <p><span style="font-family: 細明體; font-size: 11pt;">第六十一至第六十三條所列之各項教育訓練與考核應訂有書面計畫與辦法 </span></p> <p><span style="font-family: 細明體; font-size: 11pt;">，經權責單位核定後實施，修改時亦同；核定日期及修訂日期均應明記於 </span></p> <p><span style="font-family: 細明體; font-size: 11pt;">其上。 </span></p> </td> </tr> <tr> <td style="padding-bottom: 1.5pt; background-color: transparent; padding-left: 1.5pt; width: 12.08%; padding-right: 1.5pt; white-space: nowrap; padding-top: 1.5pt;border-color: #f0f0f0;" valign="top"> <p><span style="font-family: 新細明體,serif; font-size: 11pt;"><a href="http://dohlaw.doh.gov.tw/Chi/FLAW/FLAWDOC01.asp?lsid=FL013827&amp;lno=65"><span style="color: windowtext; text-decoration: none; text-underline: none;">第 &nbsp;&nbsp;65&nbsp;&nbsp;&nbsp;&nbsp; </span><span style="color: windowtext; text-decoration: none; text-underline: none;">條</span></a> </span></p> </td> <td style="padding-bottom: 1.5pt; background-color: transparent; padding-left: 1.5pt; width: 86.86%; padding-right: 1.5pt; padding-top: 1.5pt;border-color: #f0f0f0;"> <p><span style="font-family: 細明體; font-size: 11pt;">對於品質管理人員應備有其人事資料檔，檔案中應包括下列事項： </span></p> <p><span style="font-family: 細明體; font-size: 11pt;">一&nbsp; 學經歷。 </span></p> <p><span style="font-family: 細明體; font-size: 11pt;">二&nbsp; 受訓之結業證書或憑證，其內載有學員參加受訓合格結業之敘述 (技 </span></p> <p><span style="font-family: 細明體; font-size: 11pt;">&nbsp;&nbsp;&nbsp; </span><span style="font-family: 細明體; font-size: 11pt;">術員部份) 。 </span></p> <p><span style="font-family: 細明體; font-size: 11pt;">三&nbsp; 每次完成一課程或接受特別訓練之紀錄。 </span></p> <p><span style="font-family: 細明體; font-size: 11pt;">四&nbsp; 再考核紀錄。 </span></p> </td> </tr> <tr> <td style="padding-bottom: 1.5pt; background-color: transparent; padding-left: 1.5pt; width: 12.08%; padding-right: 1.5pt; white-space: nowrap; padding-top: 1.5pt;border-color: #f0f0f0;" valign="top"> <p><span style="font-family: 新細明體,serif; font-size: 11pt;"><a href="http://dohlaw.doh.gov.tw/Chi/FLAW/FLAWDOC01.asp?lsid=FL013827&amp;lno=66"><span style="color: windowtext; text-decoration: none; text-underline: none;">第 &nbsp;&nbsp;66&nbsp;&nbsp;&nbsp;&nbsp; </span><span style="color: windowtext; text-decoration: none; text-underline: none;">條</span></a> </span></p> </td> <td style="padding-bottom: 1.5pt; background-color: transparent; padding-left: 1.5pt; width: 86.86%; padding-right: 1.5pt; padding-top: 1.5pt;border-color: #f0f0f0;"> <p><span style="font-family: 細明體; font-size: 11pt;">新進與升遷之品質管理人員應於適當時間，以適當方法再考核其能力。 </span></p> </td> </tr> <tr> <td style="padding-bottom: 1.5pt; background-color: transparent; padding-left: 1.5pt; width: 12.08%; padding-right: 1.5pt; white-space: nowrap; padding-top: 1.5pt;border-color: #f0f0f0;" valign="top"> <p><span style="font-family: 新細明體,serif; font-size: 11pt;"><a href="http://dohlaw.doh.gov.tw/Chi/FLAW/FLAWDOC01.asp?lsid=FL013827&amp;lno=67"><span style="color: windowtext; text-decoration: none; text-underline: none;">第 &nbsp;&nbsp;67&nbsp;&nbsp;&nbsp;&nbsp; </span><span style="color: windowtext; text-decoration: none; text-underline: none;">條</span></a> </span></p> </td> <td style="padding-bottom: 1.5pt; background-color: transparent; padding-left: 1.5pt; width: 86.86%; padding-right: 1.5pt; padding-top: 1.5pt;border-color: #f0f0f0;"> <p><span style="font-family: 細明體; font-size: 11pt;">實施各項教育訓練後，應有書面紀錄記載實施內容及結果以供追蹤檢討。 </span></p> </td> </tr> <tr> <td style="padding-bottom: 1.5pt; background-color: transparent; padding-left: 1.5pt; width: 99.3%; padding-right: 1.5pt; padding-top: 1.5pt;border-color: #f0f0f0;" colspan="2"> <p><b><span style="font-family: 新細明體,serif; font-size: 11pt;">第&nbsp;四&nbsp;編&nbsp;製程確效</span></b> </p> </td> </tr> <tr> <td style="padding-bottom: 1.5pt; background-color: transparent; padding-left: 1.5pt; width: 12.08%; padding-right: 1.5pt; white-space: nowrap; padding-top: 1.5pt;border-color: #f0f0f0;" valign="top"> <p><span style="font-family: 新細明體,serif; font-size: 11pt;"><a href="http://dohlaw.doh.gov.tw/Chi/FLAW/FLAWDOC01.asp?lsid=FL013827&amp;lno=68"><span style="color: windowtext; text-decoration: none; text-underline: none;">第 &nbsp;&nbsp;68&nbsp;&nbsp;&nbsp;&nbsp; </span><span style="color: windowtext; text-decoration: none; text-underline: none;">條</span></a> </span></p> </td> <td style="padding-bottom: 1.5pt; background-color: transparent; padding-left: 1.5pt; width: 86.86%; padding-right: 1.5pt; padding-top: 1.5pt;border-color: #f0f0f0;"> <p><span style="font-family: 細明體; font-size: 11pt;">製程確效為針對一特定產品之製程建立書面證據之措施，以確保該製程能 </span></p> <p><span style="font-family: 細明體; font-size: 11pt;">持續穩定的產製出符合既訂規格與品質特性之產品。 </span></p> </td> </tr> <tr> <td style="padding-bottom: 1.5pt; background-color: transparent; padding-left: 1.5pt; width: 12.08%; padding-right: 1.5pt; white-space: nowrap; padding-top: 1.5pt;border-color: #f0f0f0;" valign="top"> <p><span style="font-family: 新細明體,serif; font-size: 11pt;"><a href="http://dohlaw.doh.gov.tw/Chi/FLAW/FLAWDOC01.asp?lsid=FL013827&amp;lno=69"><span style="color: windowtext; text-decoration: none; text-underline: none;">第 &nbsp;&nbsp;69&nbsp;&nbsp;&nbsp;&nbsp; </span><span style="color: windowtext; text-decoration: none; text-underline: none;">條</span></a> </span></p> </td> <td style="padding-bottom: 1.5pt; background-color: transparent; padding-left: 1.5pt; width: 86.86%; padding-right: 1.5pt; padding-top: 1.5pt;border-color: #f0f0f0;"> <p><span style="font-family: 細明體; font-size: 11pt;">執行製程確效前，其使用之設施與設備等應以已通過驗證為原則。 </span></p> </td> </tr> <tr> <td style="padding-bottom: 1.5pt; background-color: transparent; padding-left: 1.5pt; width: 12.08%; padding-right: 1.5pt; white-space: nowrap; padding-top: 1.5pt;border-color: #f0f0f0;" valign="top"> <p><span style="font-family: 新細明體,serif; font-size: 11pt;"><a href="http://dohlaw.doh.gov.tw/Chi/FLAW/FLAWDOC01.asp?lsid=FL013827&amp;lno=70"><span style="color: windowtext; text-decoration: none; text-underline: none;">第 &nbsp;&nbsp;70&nbsp;&nbsp;&nbsp;&nbsp; </span><span style="color: windowtext; text-decoration: none; text-underline: none;">條</span></a> </span></p> </td> <td style="padding-bottom: 1.5pt; background-color: transparent; padding-left: 1.5pt; width: 86.86%; padding-right: 1.5pt; padding-top: 1.5pt;border-color: #f0f0f0;"> <p><span style="font-family: 細明體; font-size: 11pt;">執行製程確效前應備有經權責單位主管核定之書面確效計畫書。確效計畫 </span></p> <p><span style="font-family: 細明體; font-size: 11pt;">書中除應包括第一編第七條之各項規定外，應明示各該製程之關鍵性參數 </span></p> <p><span style="font-family: 細明體; font-size: 11pt;">、評估方法、預訂之確效及測試方法、預計要收集的數據種類及合格標準 </span></p> <p><span style="font-family: 細明體; font-size: 11pt;">範圍等。 </span></p> </td> </tr> <tr> <td style="padding-bottom: 1.5pt; background-color: transparent; padding-left: 1.5pt; width: 12.08%; padding-right: 1.5pt; white-space: nowrap; padding-top: 1.5pt;border-color: #f0f0f0;" valign="top"> <p><span style="font-family: 新細明體,serif; font-size: 11pt;"><a href="http://dohlaw.doh.gov.tw/Chi/FLAW/FLAWDOC01.asp?lsid=FL013827&amp;lno=71"><span style="color: windowtext; text-decoration: none; text-underline: none;">第 &nbsp;&nbsp;71&nbsp;&nbsp;&nbsp;&nbsp; </span><span style="color: windowtext; text-decoration: none; text-underline: none;">條</span></a> </span></p> </td> <td style="padding-bottom: 1.5pt; background-color: transparent; padding-left: 1.5pt; width: 86.86%; padding-right: 1.5pt; padding-top: 1.5pt;border-color: #f0f0f0;"> <p><span style="font-family: 細明體; font-size: 11pt;">先期性確效包括設備之安裝驗證及性能驗證，製程確效。 </span></p> </td> </tr> <tr> <td style="padding-bottom: 1.5pt; background-color: transparent; padding-left: 1.5pt; width: 12.08%; padding-right: 1.5pt; white-space: nowrap; padding-top: 1.5pt;border-color: #f0f0f0;" valign="top"> <p><span style="font-family: 新細明體,serif; font-size: 11pt;"><a href="http://dohlaw.doh.gov.tw/Chi/FLAW/FLAWDOC01.asp?lsid=FL013827&amp;lno=72"><span style="color: windowtext; text-decoration: none; text-underline: none;">第 &nbsp;&nbsp;72&nbsp;&nbsp;&nbsp;&nbsp; </span><span style="color: windowtext; text-decoration: none; text-underline: none;">條</span></a> </span></p> </td> <td style="padding-bottom: 1.5pt; background-color: transparent; padding-left: 1.5pt; width: 86.86%; padding-right: 1.5pt; padding-top: 1.5pt;border-color: #f0f0f0;"> <p><span style="font-family: 細明體; font-size: 11pt;">執行先期性確效作業時應先驗證與評估各有關設備能在製程規定的操作上 </span></p> <p><span style="font-family: 細明體; font-size: 11pt;">下限適當的操作。本階段的確效事宜包括設備之設計，訂定校正、維護與 </span></p> <p><span style="font-family: 細明體; font-size: 11pt;">調整之有關規定，確認會影響製程與產品之關鍵性設備指標。由這些作業 </span></p> <p><span style="font-family: 細明體; font-size: 11pt;">所得之資料應使用於建立書面的製程條件，包括設備的校正、維護、監測 </span></p> <p><span style="font-family: 細明體; font-size: 11pt;">與控制。 </span></p> </td> </tr> <tr> <td style="padding-bottom: 1.5pt; background-color: transparent; padding-left: 1.5pt; width: 12.08%; padding-right: 1.5pt; white-space: nowrap; padding-top: 1.5pt;border-color: #f0f0f0;" valign="top"> <p><span style="font-family: 新細明體,serif; font-size: 11pt;"><a href="http://dohlaw.doh.gov.tw/Chi/FLAW/FLAWDOC01.asp?lsid=FL013827&amp;lno=73"><span style="color: windowtext; text-decoration: none; text-underline: none;">第 &nbsp;&nbsp;73&nbsp;&nbsp;&nbsp;&nbsp; </span><span style="color: windowtext; text-decoration: none; text-underline: none;">條</span></a> </span></p> </td> <td style="padding-bottom: 1.5pt; background-color: transparent; padding-left: 1.5pt; width: 86.86%; padding-right: 1.5pt; padding-top: 1.5pt;border-color: #f0f0f0;"> <p><span style="font-family: 細明體; font-size: 11pt;">性能驗證的目的是以嚴格的測試來證明製程的有效性與再現性，在進入確 </span></p> <p><span style="font-family: 細明體; font-size: 11pt;">效的性能驗證階段時，製程規格業已建立而且本質上已透過實驗室或其他 </span></p> <p><span style="font-family: 細明體; font-size: 11pt;">試驗方法證明為可接受者，而且設備已基於適宜的安裝驗證判定為可接受 </span></p> <p><span style="font-family: 細明體; font-size: 11pt;">者。 </span></p> </td> </tr> <tr> <td style="padding-bottom: 1.5pt; background-color: transparent; padding-left: 1.5pt; width: 12.08%; padding-right: 1.5pt; white-space: nowrap; padding-top: 1.5pt;border-color: #f0f0f0;" valign="top"> <p><span style="font-family: 新細明體,serif; font-size: 11pt;"><a href="http://dohlaw.doh.gov.tw/Chi/FLAW/FLAWDOC01.asp?lsid=FL013827&amp;lno=74"><span style="color: windowtext; text-decoration: none; text-underline: none;">第 &nbsp;&nbsp;74&nbsp;&nbsp;&nbsp;&nbsp; </span><span style="color: windowtext; text-decoration: none; text-underline: none;">條</span></a> </span></p> </td> <td style="padding-bottom: 1.5pt; background-color: transparent; padding-left: 1.5pt; width: 86.86%; padding-right: 1.5pt; padding-top: 1.5pt;border-color: #f0f0f0;"> <p><span style="font-family: 細明體; font-size: 11pt;">先期性確效應能模擬實際的生產條件，必要時應包括最差狀況在內。 </span></p> </td> </tr> <tr> <td style="padding-bottom: 1.5pt; background-color: transparent; padding-left: 1.5pt; width: 12.08%; padding-right: 1.5pt; white-space: nowrap; padding-top: 1.5pt;border-color: #f0f0f0;" valign="top"> <p><span style="font-family: 新細明體,serif; font-size: 11pt;"><a href="http://dohlaw.doh.gov.tw/Chi/FLAW/FLAWDOC01.asp?lsid=FL013827&amp;lno=75"><span style="color: windowtext; text-decoration: none; text-underline: none;">第 &nbsp;&nbsp;75&nbsp;&nbsp;&nbsp;&nbsp; </span><span style="color: windowtext; text-decoration: none; text-underline: none;">條</span></a> </span></p> </td> <td style="padding-bottom: 1.5pt; background-color: transparent; padding-left: 1.5pt; width: 86.86%; padding-right: 1.5pt; padding-top: 1.5pt;border-color: #f0f0f0;"> <p><span style="font-family: 細明體; font-size: 11pt;">先期性確效一製程時，應先確定選擇供評估之指標並將其控制，然後在控 </span></p> <p><span style="font-family: 細明體; font-size: 11pt;">制之製程條件下製造數批產品，測試是否符合規格。至少有連續三批能符 </span></p> <p><span style="font-family: 細明體; font-size: 11pt;">合規格時，該製程即通過確效。 </span></p> <p><span style="font-family: 細明體; font-size: 11pt;">關鍵性的製程指標應予以監控及記載。將監控過程所收集的數據加以分析 </span></p> <p><span style="font-family: 細明體; font-size: 11pt;">，可建立各個製程指標的變異性以及設備與製程之控制是否可確保產品符 </span></p> <p><span style="font-family: 細明體; font-size: 11pt;">合規格。 </span></p> </td> </tr> <tr> <td style="padding-bottom: 1.5pt; background-color: transparent; padding-left: 1.5pt; width: 12.08%; padding-right: 1.5pt; white-space: nowrap; padding-top: 1.5pt;border-color: #f0f0f0;" valign="top"> <p><span style="font-family: 新細明體,serif; font-size: 11pt;"><a href="http://dohlaw.doh.gov.tw/Chi/FLAW/FLAWDOC01.asp?lsid=FL013827&amp;lno=76"><span style="color: windowtext; text-decoration: none; text-underline: none;">第 &nbsp;&nbsp;76&nbsp;&nbsp;&nbsp;&nbsp; </span><span style="color: windowtext; text-decoration: none; text-underline: none;">條</span></a> </span></p> </td> <td style="padding-bottom: 1.5pt; background-color: transparent; padding-left: 1.5pt; width: 86.86%; padding-right: 1.5pt; padding-top: 1.5pt;border-color: #f0f0f0;"> <p><span style="font-family: 細明體; font-size: 11pt;">對於各種劑型之先期性製程確效應妥當選擇與各該劑型確效事項有關之關 </span></p> <p><span style="font-family: 細明體; font-size: 11pt;">鍵性參數進行。 </span></p> </td> </tr> <tr> <td style="padding-bottom: 1.5pt; background-color: transparent; padding-left: 1.5pt; width: 12.08%; padding-right: 1.5pt; white-space: nowrap; padding-top: 1.5pt;border-color: #f0f0f0;" valign="top"> <p><span style="font-family: 新細明體,serif; font-size: 11pt;"><a href="http://dohlaw.doh.gov.tw/Chi/FLAW/FLAWDOC01.asp?lsid=FL013827&amp;lno=77"><span style="color: windowtext; text-decoration: none; text-underline: none;">第 &nbsp;&nbsp;77&nbsp;&nbsp;&nbsp;&nbsp; </span><span style="color: windowtext; text-decoration: none; text-underline: none;">條</span></a> </span></p> </td> <td style="padding-bottom: 1.5pt; background-color: transparent; padding-left: 1.5pt; width: 86.86%; padding-right: 1.5pt; padding-top: 1.5pt;border-color: #f0f0f0;"> <p><span style="font-family: 細明體; font-size: 11pt;">無菌製劑確效前應執行下列關鍵性驗證： </span></p> <p><span style="font-family: 細明體; font-size: 11pt;">一&nbsp; 與無菌製劑作業場所有關之空氣供應及空氣調節系統。 </span></p> <p><span style="font-family: 細明體; font-size: 11pt;">二&nbsp; 純淨水及注射用水供應系統。 </span></p> <p><span style="font-family: 細明體; font-size: 11pt;">三&nbsp; 滅菌設備。 </span></p> <p><span style="font-family: 細明體; font-size: 11pt;">四&nbsp; 無菌製劑之充填及密封系統。 </span></p> <p><span style="font-family: 細明體; font-size: 11pt;">五&nbsp; 清潔法與衛生事宜。 </span></p> </td> </tr> <tr> <td style="padding-bottom: 1.5pt; background-color: transparent; padding-left: 1.5pt; width: 12.08%; padding-right: 1.5pt; white-space: nowrap; padding-top: 1.5pt;border-color: #f0f0f0;" valign="top"> <p><span style="font-family: 新細明體,serif; font-size: 11pt;"><a href="http://dohlaw.doh.gov.tw/Chi/FLAW/FLAWDOC01.asp?lsid=FL013827&amp;lno=78"><span style="color: windowtext; text-decoration: none; text-underline: none;">第 &nbsp;&nbsp;78&nbsp;&nbsp;&nbsp;&nbsp; </span><span style="color: windowtext; text-decoration: none; text-underline: none;">條</span></a> </span></p> </td> <td style="padding-bottom: 1.5pt; background-color: transparent; padding-left: 1.5pt; width: 86.86%; padding-right: 1.5pt; padding-top: 1.5pt;border-color: #f0f0f0;"> <p><span style="font-family: 細明體; font-size: 11pt;">無菌製劑作業場所之環境監控應予確效以確保能持續穩定的符合各該場所 </span></p> <p><span style="font-family: 細明體; font-size: 11pt;">之環境要求。 </span></p> </td> </tr> <tr> <td style="padding-bottom: 1.5pt; background-color: transparent; padding-left: 1.5pt; width: 12.08%; padding-right: 1.5pt; white-space: nowrap; padding-top: 1.5pt;border-color: #f0f0f0;" valign="top"> <p><span style="font-family: 新細明體,serif; font-size: 11pt;"><a href="http://dohlaw.doh.gov.tw/Chi/FLAW/FLAWDOC01.asp?lsid=FL013827&amp;lno=79"><span style="color: windowtext; text-decoration: none; text-underline: none;">第 &nbsp;&nbsp;79&nbsp;&nbsp;&nbsp;&nbsp; </span><span style="color: windowtext; text-decoration: none; text-underline: none;">條</span></a> </span></p> </td> <td style="padding-bottom: 1.5pt; background-color: transparent; padding-left: 1.5pt; width: 86.86%; padding-right: 1.5pt; padding-top: 1.5pt;border-color: #f0f0f0;"> <p><span style="font-family: 細明體; font-size: 11pt;">無菌製劑之滅菌確效有關事宜悉依八十四年十二月二十二日衛署藥字第八 </span></p> <p><span style="font-family: 細明體; font-size: 11pt;">四○七八七三五號函「滅菌過程確效指導手冊」之規定進行。 </span></p> </td> </tr> <tr> <td style="padding-bottom: 1.5pt; background-color: transparent; padding-left: 1.5pt; width: 12.08%; padding-right: 1.5pt; white-space: nowrap; padding-top: 1.5pt;border-color: #f0f0f0;" valign="top"> <p><span style="font-family: 新細明體,serif; font-size: 11pt;"><a href="http://dohlaw.doh.gov.tw/Chi/FLAW/FLAWDOC01.asp?lsid=FL013827&amp;lno=80"><span style="color: windowtext; text-decoration: none; text-underline: none;">第 &nbsp;&nbsp;80&nbsp;&nbsp;&nbsp;&nbsp; </span><span style="color: windowtext; text-decoration: none; text-underline: none;">條</span></a> </span></p> </td> <td style="padding-bottom: 1.5pt; background-color: transparent; padding-left: 1.5pt; width: 86.86%; padding-right: 1.5pt; padding-top: 1.5pt;border-color: #f0f0f0;"> <p><span style="font-family: 細明體; font-size: 11pt;">藥廠在其品質確保之程序中應建立有可供回溯性確效用之關鍵性指標項目 </span></p> <p><span style="font-family: 細明體; font-size: 11pt;">。 </span></p> </td> </tr> <tr> <td style="padding-bottom: 1.5pt; background-color: transparent; padding-left: 1.5pt; width: 12.08%; padding-right: 1.5pt; white-space: nowrap; padding-top: 1.5pt;border-color: #f0f0f0;" valign="top"> <p><span style="font-family: 新細明體,serif; font-size: 11pt;"><a href="http://dohlaw.doh.gov.tw/Chi/FLAW/FLAWDOC01.asp?lsid=FL013827&amp;lno=81"><span style="color: windowtext; text-decoration: none; text-underline: none;">第 &nbsp;&nbsp;81&nbsp;&nbsp;&nbsp;&nbsp; </span><span style="color: windowtext; text-decoration: none; text-underline: none;">條</span></a> </span></p> </td> <td style="padding-bottom: 1.5pt; background-color: transparent; padding-left: 1.5pt; width: 86.86%; padding-right: 1.5pt; padding-top: 1.5pt;border-color: #f0f0f0;"> <p><span style="font-family: 細明體; font-size: 11pt;">已上市之產品應就生產之連續批次執行回溯性確效。若品質嚴重不穩定須 </span></p> <p><span style="font-family: 細明體; font-size: 11pt;">改變配方、製程、製造設備等時，應於變更時執行先期性確效。如品質僅 </span></p> <p><span style="font-family: 細明體; font-size: 11pt;">呈現輕微不穩定而只須對配方、製程、製造設備等作輕微之異動時，得執 </span></p> <p><span style="font-family: 細明體; font-size: 11pt;">行併行性確效。 </span></p> </td> </tr> <tr> <td style="padding-bottom: 1.5pt; background-color: transparent; padding-left: 1.5pt; width: 12.08%; padding-right: 1.5pt; white-space: nowrap; padding-top: 1.5pt;border-color: #f0f0f0;" valign="top"> <p><span style="font-family: 新細明體,serif; font-size: 11pt;"><a href="http://dohlaw.doh.gov.tw/Chi/FLAW/FLAWDOC01.asp?lsid=FL013827&amp;lno=82"><span style="color: windowtext; text-decoration: none; text-underline: none;">第 &nbsp;&nbsp;82&nbsp;&nbsp;&nbsp;&nbsp; </span><span style="color: windowtext; text-decoration: none; text-underline: none;">條</span></a> </span></p> </td> <td style="padding-bottom: 1.5pt; background-color: transparent; padding-left: 1.5pt; width: 86.86%; padding-right: 1.5pt; padding-top: 1.5pt;border-color: #f0f0f0;"> <p><span style="font-family: 細明體; font-size: 11pt;">藥廠應建立能隨時進行確效作業之系統，以因應臨時在包裝、配方、設備 </span></p> <p><span style="font-family: 細明體; font-size: 11pt;">、或製程上有所改變而對產品之有效性或特性有所影響，以及對產品特性 </span></p> <p><span style="font-family: 細明體; font-size: 11pt;">有所改變之任何可能狀況。 </span></p> </td> </tr> <tr> <td style="padding-bottom: 1.5pt; background-color: transparent; padding-left: 1.5pt; width: 99.3%; padding-right: 1.5pt; padding-top: 1.5pt;border-color: #f0f0f0;" colspan="2"> <p><b><span style="font-family: 新細明體,serif; font-size: 11pt;">第&nbsp;五&nbsp;編&nbsp;分析確效</span></b> </p> </td> </tr> <tr> <td style="padding-bottom: 1.5pt; background-color: transparent; padding-left: 1.5pt; width: 12.08%; padding-right: 1.5pt; white-space: nowrap; padding-top: 1.5pt;border-color: #f0f0f0;" valign="top"> <p><span style="font-family: 新細明體,serif; font-size: 11pt;"><a href="http://dohlaw.doh.gov.tw/Chi/FLAW/FLAWDOC01.asp?lsid=FL013827&amp;lno=83"><span style="color: windowtext; text-decoration: none; text-underline: none;">第 &nbsp;&nbsp;83&nbsp;&nbsp;&nbsp;&nbsp; </span><span style="color: windowtext; text-decoration: none; text-underline: none;">條</span></a> </span></p> </td> <td style="padding-bottom: 1.5pt; background-color: transparent; padding-left: 1.5pt; width: 86.86%; padding-right: 1.5pt; padding-top: 1.5pt;border-color: #f0f0f0;"> <p><span style="font-family: 細明體; font-size: 11pt;">藥廠之品質管理部門應備有下列書面資料以配合確效作業： </span></p> <p><span style="font-family: 細明體; font-size: 11pt;">一&nbsp; 標準實驗室規範或基本操作規範。 </span></p> <p><span style="font-family: 細明體; font-size: 11pt;">二&nbsp; 標準試驗法。 </span></p> <p><span style="font-family: 細明體; font-size: 11pt;">三&nbsp; 對照標準品之標定與管理標準作業程序。 </span></p> <p><span style="font-family: 細明體; font-size: 11pt;">四&nbsp; 設備操作規範。 </span></p> <p><span style="font-family: 細明體; font-size: 11pt;">五&nbsp; 實驗室筆記本。 </span></p> <p><span style="font-family: 細明體; font-size: 11pt;">六&nbsp; 設備校正及維護日誌簿。 </span></p> <p><span style="font-family: 細明體; font-size: 11pt;">七&nbsp; 分析結果偏離規格時之處理方法。 </span></p> </td> </tr> <tr> <td style="padding-bottom: 1.5pt; background-color: transparent; padding-left: 1.5pt; width: 12.08%; padding-right: 1.5pt; white-space: nowrap; padding-top: 1.5pt;border-color: #f0f0f0;" valign="top"> <p><span style="font-family: 新細明體,serif; font-size: 11pt;"><a href="http://dohlaw.doh.gov.tw/Chi/FLAW/FLAWDOC01.asp?lsid=FL013827&amp;lno=84"><span style="color: windowtext; text-decoration: none; text-underline: none;">第 &nbsp;&nbsp;84&nbsp;&nbsp;&nbsp;&nbsp; </span><span style="color: windowtext; text-decoration: none; text-underline: none;">條</span></a> </span></p> </td> <td style="padding-bottom: 1.5pt; background-color: transparent; padding-left: 1.5pt; width: 86.86%; padding-right: 1.5pt; padding-top: 1.5pt;border-color: #f0f0f0;"> <p><span style="font-family: 細明體; font-size: 11pt;">各種分析方法之系統適當性、準確度、精密度、最低檢測濃度、最低定量 </span></p> <p><span style="font-family: 細明體; font-size: 11pt;">濃度、專一性、線性及再現性等，均視各該分析方法之本質、目的與需要 </span></p> <p><span style="font-family: 細明體; font-size: 11pt;">分別建立，並視各該分析方法分別確效之；執行時並記錄成檔。 </span></p> </td> </tr> <tr> <td style="padding-bottom: 1.5pt; background-color: transparent; padding-left: 1.5pt; width: 12.08%; padding-right: 1.5pt; white-space: nowrap; padding-top: 1.5pt;border-color: #f0f0f0;" valign="top"> <p><span style="font-family: 新細明體,serif; font-size: 11pt;"><a href="http://dohlaw.doh.gov.tw/Chi/FLAW/FLAWDOC01.asp?lsid=FL013827&amp;lno=85"><span style="color: windowtext; text-decoration: none; text-underline: none;">第 &nbsp;&nbsp;85&nbsp;&nbsp;&nbsp;&nbsp; </span><span style="color: windowtext; text-decoration: none; text-underline: none;">條</span></a> </span></p> </td> <td style="padding-bottom: 1.5pt; background-color: transparent; padding-left: 1.5pt; width: 86.86%; padding-right: 1.5pt; padding-top: 1.5pt;border-color: #f0f0f0;"> <p><span style="font-family: 細明體; font-size: 11pt;">新購置之分析儀器應執行安裝、操作與性能驗證，器具應視其本質必要時 </span></p> <p><span style="font-family: 細明體; font-size: 11pt;">執行之。 </span></p> </td> </tr> <tr> <td style="padding-bottom: 1.5pt; background-color: transparent; padding-left: 1.5pt; width: 12.08%; padding-right: 1.5pt; white-space: nowrap; padding-top: 1.5pt;border-color: #f0f0f0;" valign="top"> <p><span style="font-family: 新細明體,serif; font-size: 11pt;"><a href="http://dohlaw.doh.gov.tw/Chi/FLAW/FLAWDOC01.asp?lsid=FL013827&amp;lno=86"><span style="color: windowtext; text-decoration: none; text-underline: none;">第 &nbsp;&nbsp;86&nbsp;&nbsp;&nbsp;&nbsp; </span><span style="color: windowtext; text-decoration: none; text-underline: none;">條</span></a> </span></p> </td> <td style="padding-bottom: 1.5pt; background-color: transparent; padding-left: 1.5pt; width: 86.86%; padding-right: 1.5pt; padding-top: 1.5pt;border-color: #f0f0f0;"> <p><span style="font-family: 細明體; font-size: 11pt;">各種既有之儀器、器具、計量器、及記錄器之校正，應依據書面計畫適當 </span></p> <p><span style="font-family: 細明體; font-size: 11pt;">定期執行之。該書面計畫之內容包括： </span></p> <p><span style="font-family: 細明體; font-size: 11pt;">一&nbsp; 特別指示事項。 </span></p> <p><span style="font-family: 細明體; font-size: 11pt;">二&nbsp; 時間表。 </span></p> <p><span style="font-family: 細明體; font-size: 11pt;">三&nbsp; 準確度、精密度範圍。 </span></p> <p><span style="font-family: 細明體; font-size: 11pt;">四&nbsp; 不能符合準確度、精密度範圍之因應措施等。 </span></p> </td> </tr> <tr> <td style="padding-bottom: 1.5pt; background-color: transparent; padding-left: 1.5pt; width: 12.08%; padding-right: 1.5pt; white-space: nowrap; padding-top: 1.5pt;border-color: #f0f0f0;" valign="top"> <p><span style="font-family: 新細明體,serif; font-size: 11pt;"><a href="http://dohlaw.doh.gov.tw/Chi/FLAW/FLAWDOC01.asp?lsid=FL013827&amp;lno=87"><span style="color: windowtext; text-decoration: none; text-underline: none;">第 &nbsp;&nbsp;87&nbsp;&nbsp;&nbsp;&nbsp; </span><span style="color: windowtext; text-decoration: none; text-underline: none;">條</span></a> </span></p> </td> <td style="padding-bottom: 1.5pt; background-color: transparent; padding-left: 1.5pt; width: 86.86%; padding-right: 1.5pt; padding-top: 1.5pt;border-color: #f0f0f0;"> <p><span style="font-family: 細明體; font-size: 11pt;">安定性有關事宜因另行規定，惟有關之恆溫恆濕裝置應符合安裝、操作及 </span></p> <p><span style="font-family: 細明體; font-size: 11pt;">性能驗證有關規定。 </span></p> </td> </tr> <tr> <td style="padding-bottom: 1.5pt; background-color: transparent; padding-left: 1.5pt; width: 99.3%; padding-right: 1.5pt; padding-top: 1.5pt;border-color: #f0f0f0;" colspan="2"> <p><b><span style="font-family: 新細明體,serif; font-size: 11pt;">第&nbsp;六&nbsp;編&nbsp;附則</span></b> </p> </td> </tr> <tr> <td style="padding-bottom: 1.5pt; background-color: transparent; padding-left: 1.5pt; width: 12.08%; padding-right: 1.5pt; white-space: nowrap; padding-top: 1.5pt;border-color: #f0f0f0;" valign="top"> <p><span style="font-family: 新細明體,serif; font-size: 11pt;"><a href="http://dohlaw.doh.gov.tw/Chi/FLAW/FLAWDOC01.asp?lsid=FL013827&amp;lno=88"><span style="color: windowtext; text-decoration: none; text-underline: none;">第 &nbsp;&nbsp;88&nbsp;&nbsp;&nbsp;&nbsp; </span><span style="color: windowtext; text-decoration: none; text-underline: none;">條</span></a> </span></p> </td> <td style="padding-bottom: 1.5pt; background-color: transparent; padding-left: 1.5pt; width: 86.86%; padding-right: 1.5pt; padding-top: 1.5pt;border-color: #f0f0f0;"> <p><span style="font-family: 細明體; font-size: 11pt;">下列各項藥品不適用於本基準，其製程確效方法另訂： </span></p> <p><span style="font-family: 細明體; font-size: 11pt;">一&nbsp; 原料血漿及血液製劑中間產品，無法以明確之批次紀錄記載者。 </span></p> <p><span style="font-family: 細明體; font-size: 11pt;">二&nbsp; 訂有經過確效之中間階段檢定基準之藥品且經主管機關核准不須執行 </span></p> <p><span style="font-family: 細明體; font-size: 11pt;">&nbsp;&nbsp;&nbsp; </span><span style="font-family: 細明體; font-size: 11pt;">確效者。 </span></p> <p><span style="font-family: 細明體; font-size: 11pt;">三&nbsp; 經中央衛生主管機關明令公告免予執行確效之藥品。 </span></p> </td> </tr> <tr> <td style="padding-bottom: 1.5pt; background-color: transparent; padding-left: 1.5pt; width: 12.08%; padding-right: 1.5pt; white-space: nowrap; padding-top: 1.5pt;border-color: #f0f0f0;" valign="top"> <p><span style="font-family: 新細明體,serif; font-size: 11pt;"><a href="http://dohlaw.doh.gov.tw/Chi/FLAW/FLAWDOC01.asp?lsid=FL013827&amp;lno=89"><span style="color: windowtext; text-decoration: none; text-underline: none;">第 &nbsp;&nbsp;89&nbsp;&nbsp;&nbsp;&nbsp; </span><span style="color: windowtext; text-decoration: none; text-underline: none;">條</span></a> </span></p> </td> <td style="padding-bottom: 1.5pt; background-color: transparent; padding-left: 1.5pt; width: 86.86%; padding-right: 1.5pt; padding-top: 1.5pt;border-color: #f0f0f0;"> <p><span style="font-family: 細明體; font-size: 11pt;">各種確效及驗證作業完成後，各合格事項應以適當方法及措施予以監控維 </span></p> <p><span style="font-family: 細明體; font-size: 11pt;">持。當此等方法或措施有須更改時，應由確效權責單位先對擬改用之監控 </span></p> <p><span style="font-family: 細明體; font-size: 11pt;">方法進行評估，如可能對產品品質有顯著影響時，應進行再確效。 </span></p> </td> </tr> </tbody></table>
發佈日期 2013-12-05
附件檔案