國內藥廠持續性安定性試驗專案查核結果分析   全文下載

Results of Inspection on Domestic Manufacturers’ On-going Stability Studies Project

藥品上市後應持續進行安定性試驗，監測在架儲期的全期，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（以下簡稱食藥署）自102年起辦理國內藥廠「持續性安定性試驗」主題式專案查核，實地瞭解國內西藥製劑廠持續性安定性試驗之方式及結果是否合乎優良製造規範，確保產品符合上市許可的要求，保障民眾用藥安全。102至105年間，食藥署派員赴廠查核共144廠次，抽樣西藥製劑產品共547件品項檢驗，其中66件品項不合格，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。食藥署藉由專案查核及抽驗產品，確保國內西藥製劑廠落實執行上市後產品之安定性試驗，亦可避免不合格藥品流通於市面上，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及維護民眾用藥安全。

The post-marketing on-going stability studies of the medicinal product should be conducted throughout its shelf life to demonstrate that, the product specification can be maintained under the labelled storage condition. Since 2013, the Taiwan Food and Drug Administration (TFDA) started a project to inspect the compliance of PIC/S GMP requirement of on-going stability programs. This article analyzed data from the 144 inspections and 547 samples tested against their specification from 2013 to 2016. The results showed that 66 samples failed. The pharmaceutical manufacturers of those misbranded drugs were required to initiate product recall promptly and followed with investigation to take appropriate and effective corrective and preventive actions. By performing inspection project, sampling and testing, TFDA ensures the domestic manufacturers would conduct post-marketing on-going stability programs, thus to avoid misbranded product sales on the market, and advance the management of the pharmaceutical manufacturers to ensure medicinal products’ safety and quality supplied in Taiwan for the general public.