- 期刊
國內西藥廠主題式專案查核結果分析
Result Analysis of Specific Inspection Project on Domestic Pharmaceutical Manufacturers
摘要
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。
並列摘要
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.
延伸閱讀
- 顏宏家、曾國峰、陳詩穎、謝綺雯、王淑芬、李明鑫（2018）。國內藥廠數據完整性專案查核結果研析。食品藥物研究年報，(9)，379-388。https://www.airitilibrary.com/Article/Detail?DocID=22195718-201812-201901110010-201901110010-379-388
- 林中豪、謝綺雯、陳映樺、遲蘭慧、李明鑫（2020）。國內藥廠品質被授權人管理現況調查。食品藥物研究年報，(11)，343-351。https://www.airitilibrary.com/Article/Detail?DocID=22195718-202012-202101210008-202101210008-343-351
- 黃興進、洪銘建（2003）。國內藥廠採用電子採購交易模式之實證研究。資管評論，(12)，49-78。https://doi.org/10.6131/MISRb.200306_(12).0003
- 蘇柏駿、林中豪、傅淑卿、謝綺雯、陳映樺、遲蘭慧（2022）。我國西藥優良運銷作業冷鏈藥品管理與查核結果分析。食品藥物研究年報，(13)，275-281。https://www.airitilibrary.com/Article/Detail?DocID=22195718-N202301090006-00030
- 許慧娟、黃瀚賜、陳映樺、李明鑫（2016）。Survey on the GMP Qualification of Imported Active Pharmaceutical Ingredients。食品藥物研究年報，(7)，295-300。https://www.airitilibrary.com/Article/Detail?DocID=22195718-201612-201701260015-201701260015-295-300