製藥廠品管實驗室GMP稽查備忘錄適用性與修訂範圍之探討

Survey on the Usefulness and Items Revision in Aide-Memoires on Inspection of Quality Control Laboratory

國際醫藥品稽查協約組織（The Pharmaceutical Inspection Co-operation Scheme，簡稱PIC／S）係由各國GMP稽查權責機關組成之國際合作組織，旨意在促進各國藥品GMP稽查一致性，該組織出版之「品管實驗室稽查備忘錄」，提供稽查員稽查品管實驗室時之參考。本研究以問卷方式調查與分析各國稽查單位對於現行的「品管實驗室稽查備忘錄」之使用適用性以及需要修訂或新增章節的建議。調查結果顯示，「PIC／S品管實驗室稽查備忘錄」在適用性評價上，獲得7.7分（滿分10分），顯示大部分稽查單位認為該文件可做為稽查時之參考。此外，「品管實驗室稽查備忘錄」之主文與補充文件合計共45個作業項目、167個重點及185個關鍵問題，其中有關分析方法確效、電子數據／電腦系統、趨勢分析、實驗室文件及資料追溯為最多稽查單位提出修訂需求之作業項目，顯示隨著法規的進展及實驗技術的演進，目前「PIC／S品管實驗室稽查備忘錄」已不敷使用，本次調查結果，將做為未來修訂該文件之參考。 The Pharmaceutical Inspection Co-operation Scheme (PIC/S) is an international co-operative arrangement which is composed of GMP regulatory authorities from all over the world for promoting the consistency of inspection procedures. The ＂Aide-Memoires on Inspection of Quality Control Laboratory＂ (Aide-Memoires) published by PIC/S is the guidance for GMP inspectors to carry an inspection on a QC Lab located at pharmaceutical manufacturers. This study is aimed at reviewing the usefulness and items need to be revised of Aide-Memoires by conducting a questionnaire survey of competent authorities from different countries. The survey results showed that the Aide-Memoires was scored 7.7 in average out of 10 in the aspect of usefulness, meaning that most GMP regulatory authorities considered the Aide- Memoires is useful guidance for QC Lab inspection. However, among 45 items, 167 notes and 185 Crucial Questions in this document, Validation of Test Methods, Electronic Documentation/Computerized Systems, Trending, Laboratory documentation and Data traceability are the top 5 items that most GMP regulatory authorities recommend for revisions. The outcome of this survey illustrated that, as the GMP requirements progressed and testing techniques improved, current ＂Aide-Memoires on Inspection of Quality Control Laboratory＂ does need to be amended. This study will benefit further amendment of Aide-Memoires.