國外衛生主管機關查核藥廠之常見GMP缺失分析   全文下載

An Analysis of the Common Findings in GMP Inspections by Foreign Regulatory Authorities

藥品可以治療疾病，然而藥品製造過程中疏失也可能對生命造成嚴重的影響，近期國際發生藥品不良品事件，起因為藥廠未依照藥物優良製造規範（GMP）執行生產作業導致嚴重危害。因此為確保藥品品質，各國衛生主管機關持續透過定期或不定期查核，以確保GMP（Good Manufacturing Practice）的落實度。本研究分析美國FDA（United States Food and Drug Administration）、英國MHRA（Medicines and Healthcare Products Regulatory Agency）、愛爾蘭HPRA（Health Products Regulatory Authority）及澳洲TGA（Therapeutic Goods Administration）等國家衛生主管機關近年針對境內及境外藥廠查核常見缺失以及嚴重違反GMP缺失，結果發現各國主管機關查核常見缺失主要分布於製藥品質系統，嚴重缺失主要為「製藥品質系統未正常運作」、「偏差、產品缺陷及怨訴未調查其根本原因或未執行適當矯正與預防措施」、「產品放行之程序未明訂及落實執行」等。衛生福利部食品藥物管理署（下稱食藥署）借鏡分析國外衛生主管機關查核藥廠常見缺失，了解業者常見之違失情節以及需要持續關注的面向，可供國內業者自我檢視，持續精進製藥品質系統，提供高品質藥品以守護國人用藥安全。

Drugs can be used to cure diseases, however, they can cause serious impact on life if the manufacturing processes are not well controlled. Recently, there have been reports regarding incidents of defective drugs due to failure to follow the Good Manufacturing Practice (GMP). To safeguard the quality and safety of drugs, routine inspections and for-case inspections are continuously conducted by the Competent Authorities to ensure that all drugs on the market are produced in accordance with the GMP standards. This study analyzed the common findings and the top ten critical findings in domestic and foreign GMP inspections of the Food and Drug Administration of US, the Medicines and Healthcare Products Regulatory Agency of UK, the Health Products Regulatory Authority of Ireland, and the Therapeutic Goods Administration of Australia. The results showed that the common findings are mainly related to the pharmaceutical quality system, and the critical findings are mainly on“failure in the implementation of the pharmaceutical quality system”,”missing of investigation in the root causes or implementation of the appropriate corrective and preventive measures of deviations, product defects and complaints”,”failure in the implementation of the procedures for product release“and etc. This study serves as a reference for Taiwan Food and Drug Administration to understand the common findings of onsite inspections on the manufacturers worldwide. It also serves as a training material for the manufacturers for self-improvement to produce high-quality drugs, and therefore to ensure drug safety for the general public.