- 期刊
國際間採認製藥廠GMP查核結果之分析探討
Survey on GMP Inspections Reliance among PIC/S Participating Authorities
摘要
國際醫藥品稽查協約組織（The Pharmaceutical Inspection Convention and Pharmaceutical Inspection Co-operation Scheme, PIC/S）係由各國藥品GMP稽查權責機關組成之國際合作組織，旨在促進各國藥品GMP法規調和及稽查標準一致性，為會員間藥品GMP國際合作之平台。為了解國際稽查趨勢及PIC/S會員間採認查核結果之情形，本研究統計分析2016-2018年期間PIC/S會員執行之海外藥廠稽查，結果發現PIC/S會員每年執行之海外查廠總數皆超過1,000廠次，涵蓋全球超過80個國家，其中逾半數以上的受查藥廠位於非PIC/S會員國境內，主要為印度及中國大陸，而赴其他會員國境內執行海外查廠的情形約占PIC/S會員海外稽查的40%；研究並發現有超過300家藥廠在近3年內被不同PIC/S會員重複查核之情形。配合PIC/S組織推動以書面審查取代實地查廠之合作模式，食藥署將朝向整合國際資源來落實藥廠GMP管理。
並列摘要
The Pharmaceutical Inspection Convention and Pharmaceutical Inspection Co-operation Scheme (PIC/S) is an international co-operative arrangement which is composed of Regulatory Authorities in the field of Good Manufacturing Practice (GMP) of medicinal products, which aims at harmonizing GMP standards and quality systems of inspectorates worldwide and facilitating co-operation and networking among competent authorities and international organizations, thus raising mutual confidence. In this study, data collected from the listed foreign inspections between 2016 and 2018 conducted by PIC/S Participating Authorities (PA), were analyzed for the trend of foreign inspections worldwide and the degree of mutual trust among PIC/S PA. The survey showed that more than 1,000 inspections were conducted by PIC/S PAs each year in over 80 countries. Based on the principle of risk management, more than half of the foreign inspections were conducted in non-PIC/S member states, mainly in India and Mainland China; however, still 40% of the inspections in PIC/S member states. Furthermore, the study also revealed that more than 300 pharmaceutical manufacturers were repeatedly inspected by different PIC/S PAs during the period. Taiwan FDA would coordinate with PIC/S to promote GMP inspection reliance by assessing the GMP compliance of foreign pharmaceutical manufacturers through desktop inspection instead of onsite inspection.