國內西藥廠主題式專案查核結果分析   全文下載

Result Analysis of Specific Inspection Project on Domestic Pharmaceutical Manufacturers

藥品上市後應依適當計畫持續監測安定性試驗之結果，確保架儲期全程之品質，確定在所標示的儲存條件下，其品質仍可維持在其規格內。衛生福利部食品藥物管理署（下稱食藥署）自106年起辦理國內藥廠「持續性安定性試驗及數據完整性」主題式查核，實地了解國內西藥製劑廠及原料藥廠是否落實持續性安定性試驗。106年至109年間，食藥署派員赴廠查核共109廠次，抽樣西藥製劑產品或原料藥共206件品項檢驗，其中16個品項不合格，皆要求藥廠自市面上回收，並責請廠商依規定執行調查與改善。食藥署藉由主題式查核及抽驗產品，確保國內西藥製劑廠及原料藥廠落實執行上市後產品之安定性試驗，有效監督國內西藥廠之GMP實務作業，提升管理效能，並確保國內藥品品質以維護民眾用藥安全。

The post-marketing on-going stability studies of the medicinal product should be conducted throughout its shelf life to ensure that, the product specification can be maintained under the labelled storage condition. Since 2017, the Taiwan Food and Drug Administration (TFDA) started an inspection project to focus on the implementing on-going stability studies and data integrity of domestic pharmaceutical manufacturers. This study collected and analyzed data from 109 inspections and 206 samples tested against their specification from 2017 to 2020. The results showed that 16 samples failed to meet established specification. The pharmaceutical manufacturers of those medicinal products were required to initiate product recall promptly and followed the investigation to take appropriate and effective corrective and preventive actions. By performing inspection project, sampling and testing, TFDA supervises the domestic manufacturers to implement post-marketing on-going stability programs, and advance the management of the pharmaceutical manufacturers to ensure medicinal products' safety and quality supplied to the public in Taiwan.