我國原料藥廠外銷現況暨實施GMP情形調查

Survey on the Products for Export of Active Pharmaceutical Ingredients and Implementation of GMP in Domestic Manufacturers

許慧娟(Hui-Chuan Hsu) ； 陳映樺(Ying-Hua Chen) ； 林育靜(Yu-Ching Lin) ； 李明鑫(Ming-Shin Lee) ； 陳惠芳(Hwei-Fang Cheng)

《食品藥物研究年報》 4期 (2013/11) Pp. 475-480

摘要

為確保藥品製造之品質，應加強原料藥之源頭管理，因此規劃原料藥廠實施GMP為重要目標之一。本研究係採問卷調查方式，針對目前國內持有原料藥許可證之藥廠進行問卷調查，以了解藥廠生產原料藥包括外銷原料藥及執行GMP之概況，並由藥廠自評廠內可全面完成GMP之時程，統計結果將作為未來推動原料藥實施GMP之參考。本次回復問卷之原料藥廠共計37家，其中具有原料藥品項通過我國GMP評鑑之藥廠有21家佔57%，生產原料藥外銷至他國之藥廠有22家佔59%，通過他國衛生主管機關或國際機構之GMP查核的有14家佔40%。目前我國對於原料藥之管理係由藥廠依原料藥品項主動申請評鑑之方式，經統計有145個品項（39%）通過我國GMP查核，有72個品項（19%）通過他國衛生主管機關或國際機構的查核。另調查結果顯示92%的藥廠贊成TFDA公告原料藥廠全面實施GMP，且高達73%的藥廠自評於104年，廠內所有原料藥品項可完成實施GMP，該結果可作為我國訂定實施原料藥GMP之時程參考，並可望將完成原料藥GMP之時程提前至104年底，及早符合國際趨勢，有助於我國製藥業者產品品質之提升。

關鍵字

原料藥藥廠 ； 原料藥GMP評鑑

並列摘要

To ensure the quality of pharmaceuticals, it is a key issue for Active Pharmaceutical Ingredients (API) manufacturers to secure and guarantee their quality systems. Therefore, it is one of important policy objectives of domestic API manufacturers to comply with Good Manufacturing Practice (GMP). In order to be acquainted with the state of play of API export and implementation of GMP of API manufacturers, a survey of API market license holders was conducted using questionnaires. The statistical results will serve as a reference for the implementation of GMP for APIs in the future. A total of 37 questionnaires showed that 21 (57%) API manufacturers have been inspected and found to comply with GMP standard. There were 22 (59%) API manufacturers exporting their products to foreign countries and 14 (40%) of them have been inspected by other countries' competent health authorities or international agencies and found to comply with GMP standard. Moreover, 145 (39% of the total) and 72 (19% of the total) API products have been inspected by our competent authorities and other countries' competent health authorities or international agencies, respectively. The survey results also showed that 92% of API manufacturers have agreed the announcement and implementation of GMP for APIs, and 73% of API manufacturers thought they can accomplish the goal that all of their API products are in compliance with GMP by 2015. As a result, the schedule for implementing GMP for APIs in 2017 could be advanced. That way, the manufacturing quality of domestic API manufacturers could soon be improved to the international level.

並列關鍵字

Active Pharmaceutical Ingredients' manufacturers ； Inspected and found to comply with GMP standard