99-100年度我國西藥製劑廠執行PIC/S GMP之調查研究

Survey on the Compliance of PIC/S GMP in Domestic Western Pharmaceutical Manufacturers

陳惠玲(Hui-Ling Chen) ； 陳映樺(Ying-Hua Chen) ； 黃琴喨(Chyn-Liang Huang) ； 李明鑫(Ming-Shin Lee) ； 陳惠芳(Hwei-Fang Cheng)

《食品藥物研究年報》 3期 (2012/12) Pp. 230-236

https://doi.org/10.6945/ARFDR.201212.0230

摘要

為提升我國製藥產業之國際化，衛生署於96年12月19日公告「西藥製劑製造工廠實施國際GMP標準（PIC/S GMP）之時程，規定於99年1月1日正式實施，並訂於104年1月1日起全面完成實施」。本研究係採問卷調查方式，分別於99及100年針對國內藥廠執行PIC/S GMP狀況及預計全面符合時程進行調查，以了解國內藥廠99至100年度執行PIC/S GMP之情形，並提供政策執行成效評估之參考。99年調查結果，近9成以上業者願意配合實施PIC/S GMP之時程，進行相關改善作業，已有27家藥廠提出PIC/S GMP符合性評鑑申請。100年調查結果，預定於103年底前提出PIC/S GMP符合性查核之藥廠佔88%，其餘12%藥廠將不提出PIC/S GMP符合性評鑑申請，改採委託製造或停止生產部分產品，已有47家藥廠提出PIC/S GMP符合性評鑑申請。由調查結果顯示在政府與業者持續合作下，國內大部分藥廠皆已配合公告時程規劃與執行PIC/SGMP，將可順利全面完成實施國際GMP，即早符合國際GMP標準，確立我國生產之藥品品質與國際水準同步。

關鍵字

藥品優良製造規範 ； PIC/S GMP ； 西藥製劑藥廠

並列摘要

To safeguard the quality of pharmaceutical manufacturing plays an important role in drug management systems. It also is a key issue for western pharmaceuticals manufacturers to secure and guarantee their own quality systems. While the campaign of quality systems and standards is harmonized under the frameworks, regulations and requirements of international good manufacturing guidance, it is the critical timing for Taiwan to step out to meet, adopt and adapt global Good Manufacturing Practice (GMP) standards in pharmaceutical sector. The implementing timeframe of the international GMP standards in Taiwan was announced at December 19th, 2007 by Department of Health, Taiwan. The Guide to Good Manufacturing Practice for Medicinal Products, published by the Pharmaceutical Inspection Cooperation Scheme (PIC/S) was used as the basis for inspections since January 1st, 2010, and all western pharmaceuticals manufacturers should be inspected to comply with the international GMP by the end of 2014.In order to be acquainted with the implementing conditions of PIC/S GMP in domestic western pharmaceuticals manufacturers, the surveys were carried out both in 2010 and 2011 using the questionnaires by inquiring into the compliance status and timetable for complete compliance with PIC/S GMP. The survey result of PIC/S GMP compliance status in 2010 showed that 27 western pharmaceuticals manufacturers have applied the assessment/inspection of PIC/S GMP. Around 90% of western pharmaceuticals manufacturers were willing to follow the announced timeframe to upgrade their facilities and systems. The result in 2011 showed that 47 western pharmaceuticals manufacturers have applied the assessment/inspection of PIC/S GMP. Almost 88% of western pharmaceuticals manufacturers indicated they were going to apply the assessment/inspection of PIC/S GMP compliance by the end of 2013. The other 12% of western pharmaceuticals manufacturers, who considered themselves not compliant with PIC/S GMP, were planning to contract manufacturing or stop production of certain products.The survey results showed that most of domestic pharmaceutical manufacturers have followed the announced timeframe to implement the PIC/S GMP. The cooperation of industry and regulator shall accelerate to completely comply with international GMP, reach a new milestone of pharmaceutical manufacturing authorization system, and achieve the win-win status of consumer, pharmaceutical industry and government.

並列關鍵字

Good Manufacturing Practice ； PIC/S GMP ； western pharmaceuticals manufacturers