我國推動原料藥廠實施GMP管理制度之研究

A Study on the Promotion of GMP Guidelines for Active Pharmaceutical Ingredients in Taiwan

曾國峰(KUO-FENG TSENG) ； 邱文銹(WEN-HSIU CHIU) ； 謝綺雯(CHI-WEN HSIEH) ； 李明鑫(MING-SHIN LEE)

《食品藥物研究年報》 8期 (2017/11) Pp. 309-314

摘要

原料藥攸關製劑產品的品質，為確保原料藥的製造品質，落實源頭管理，各國已立法實施原料藥優良製造規範(GMP)，國際醫藥品稽查協約組織(PIC/S)亦於2007年4月5日公告藥品優良製造規範第二部原料藥GMP，我國已參照該組織公告之標準擬訂國內原料藥優良製造規範並於2015年12月31日全面完成實施。本研究探討各國原料藥管理規範與我國推動原料藥GMP之管理措施，健全我國與國際接軌之原料藥GMP管理制度，確保藥品製造品質，維護民眾用藥安全。

關鍵字

原料藥 ； 優良製造規範

並列摘要

The quality of pharmaceutical products is dependent on the raw materials or active pharmaceutical ingredients (APIs) used. Therefore, many countries have established Good Manufacturing Practice (GMP) guidelines for APIs. On 5 April 2007, GMP guidelines Part II on APIs for Medicinal Products were published by the Pharmaceutical Inspection Convention and Pharmaceutical Inspection Co-operation Scheme (PIC/S). The Taiwan FDA had formulated guidelines for local manufactures in accordance with the international standards and implemented them on 31 December 2015. In this study, we discussed the management of APIs in different countries and the implementation process of GMP guidelines for APIs in Taiwan. The Purpose was to ensure that the local guidelines met international standards and pharmaceutical products in Taiwan were of good quality and safe for use.

並列關鍵字

active pharmaceutical ingredients (APIs) ； good manufacturing practice (GMP)