國內藥廠品質被授權人管理現況調查   全文下載

Survey on Management of Authorised Person in Domestic Pharmaceutical Firms

為保障民眾用藥安全，我國積極推動藥品GMP管理制度與國際接軌，並於102年起加入國際醫藥品稽查協約組織PIC／S，參照其公布之GMP相關法規，持續更新我國藥品GMP管理制度與標準。近年來，隨著品質觀念的革新，國際間推動藥品「品質被授權人（Authorised Person, AP）」管理制度，以確保每一批次藥品已遵循國家法律及依照上市許可之要求進行製造、檢驗與放行。本研究藉資料蒐集及數次問卷調查國內GMP藥廠所聘用之AP人員之學歷、製藥資歷及所在部門等，探討各廠對藥品製造品質的把關機制及AP設置情形，結果發現108年底藥廠皆已設有1位以上AP人員，主要AP為藥師者佔38.1％，AP為藥師之比例有逐年提升之趨勢，食藥署將參考國際趨勢及調查結果，訂定合適之AP管理制度。

To safeguard public use of medicinal products, Taiwan Food and Drug Administration (TFDA) proactively integrated GMP management policy into international standard. As the participating authority of the Pharmaceutical Inspection Convention and Pharmaceutical Inspection Co-operation Scheme (PIC/ S) since 2013, TFDA has kept renewing GMP related regulations with reference to the PIC/S GMP guide. In recent years, with the innovation of quality concept, many countries promote the practice of Authorised Person (AP) for the purpose of ensuring each production batch of medicinal products has been manufactured, controlled and released in compliance with the requirements of national laws and Marketing Authorisation. In order to discuss quality system and current situation of AP in pharmaceutical manufacturers, this study gathered information from the international practice and conducted questionnaire survey on educational background, pharmaceutical qualification and current department of the AP in domestic pharmaceutical manufacturers. The results from the survey of 2019 showed that pharmaceutical manufacturers all had appointed more than one AP, which 38.1% of them were pharmacist, and the number increased year after year. TFDA would stipulate appropriate management system according to international trend and survey results.