第一届台湾药学联合学术研讨会.PDFVIP

【臺灣藥學聯合學術研討會】 符合FDA規範之分析方法確效作業實務研討 背景介紹 • 為提升國內製藥品質、避免藥品在製造過程中可能產生之交叉污 染，以及在生產過程中誤用不當原/物料之情形，政府在1982年開 始推動GMP(Good Manufacturing Practice, GMP)藥品優良製造規範。 • 為確保及提升藥物品質，政府已全面實施藥品優良製造規範 (GMP) ，對於與分析藥物品質有關的分析方法，也另有「分析確 效作業指導手冊」規範。優良成熟的製造技術及品質管制，可決 定所生產的藥物品質，而品管檢驗更需要可靠有效的量測技術； 因此一個具有可靠性的分析檢測方法，是整個藥物製程確效及維 持藥物品質的基礎。 FDA 對分析方法確效的定義 Analytical method validation is the process of demonstrating that an analytical procedure is suitable for its intended purpose. The methodology and objective of the analytical procedures should be clearly defined and understood before initiating validation studies. This understanding is obtained from scientifically-based method development and optimization studies. 分析方法的確效，其主要的目的在於確認該方法是否確實達到適用 於所期望檢測之目的，因此分析方法的確效是由實驗室經研究後所 建立之程序，且顯示此方法符合欲分析應用需求時的特徵。所以為 確保分析數據之準確性及可靠度，應建立合適的分析方法。 ~Analytical Procedures and Methods Validation for Drugs and Biologics Guidance for Industry July 2015 FDA 在審核送件時常發現的問題 • Analytical methods that applicants use for the characterization or analysis of drug products should be validated by the applicant to determine if these methods are suitable for such use. However, applicants have failed to appropriately validate their analytical methods, which has led to incorrect results and incorrect conclusions about the drug product quality because the analytical methods were not specific, accurate, or precise. This failure has contributed to FDA’s refusal to approve the ANDAs. Good ANDA submission practices January by FDA 2018 FDA 建議的參考資料 • ICH Q2 (R1) Validation of analytical procedures: Text and Methodology (1995) • FDA Q2B Validation of analytical procedures: Methodology (1996) • FDA Analytical procedures and methods validation for drugs and biologics (2015) • USP 1225 Validation of Compendial Methods