實施PIC/S GMP提升臺灣製藥品質

藥品實施優良製造規範（Good Manufacturing Practice, GMP）是確保製藥品質的關鍵措施，為保障民眾用藥安全，自1982年開始要求藥品製造必須符合GMP，並隨著品質觀念的革新，不斷更新我國西藥GMP的規範。因應國際GMP規範不斷的提升，於2013年1月起領先日韓，正式成為國際醫藥品稽查協約組織（PIC/S）會員，並於2014年12月31日全面完成西藥製劑工廠實施更加嚴謹的國際PIC/SGMP製藥標準，臺灣製藥品質已全面升級並順利與國際接軌，邁入嶄新紀元，使國人得以享受與先進國家相同的用藥品質。為落實全方位的消費者保護，我國持續推動以藥品生命週期的品質管理政策，健全上游端原料的源頭管理，與下游端供應鏈的運銷管理，藉由推動原料藥實施GMP及藥品推動優良運銷規範（Good Distribution Practice, GDP），健全藥品管理制度，完整保護消費者用藥品質與安全。

關鍵字

優良製造規範；優良運銷規範；國際醫藥品稽查協約組織

並列摘要

Good Manufacturing Practices (GMP) is the key to assuring quality of pharmaceutical products. To safeguard public use of pharmaceutical products, mandatory GMP implementation and compliance by all manufacturers was announced in 1982 by the Department of Health, Taiwan, and is kept up-to-date with global new quality concepts and development. In response to the global advancing of GMP standards and in an effort to continue to enhance, Taiwan Food and Drug Administration (TFDA) applied for the membership of the Pharmaceutical Inspection Co-operation Scheme (PIC/S), which was accepted and as of 1 January 2013, ahead of Japan and Korea, become one of the participating authorities. Then within two years by 31 December 2014, all medicinal products manufacturers are in compliance with the more stringent PIC/S GMP standards. Taiwan has evolved into a new era of which the current standard is improved and harmonized with the global standards, and the public benefits from the quality of medicinal products similar to those in the advance countries. Due regard to public health and safeguard in a comprehensive manner, Taiwan continues to implement measures for quality assurance in respect of product life cycle management. This will include promoting GMP for Active Pharmaceutical Ingredients (API) and the Good Distribution Practice (GDP), complementing the scope of quality from the source to the distribution. As such, public safety and medicinal product quality is protected, across-the-board.

並列關鍵字

GMP ； GDP ； PIC/S

國際替代計量

實施PIC/S GMP提升臺灣製藥品質

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