頁籤選單縮合
題 名 | 我國西藥廠執行PIC/S GMP之調查研究=Survey on the Implementation of PIC/S GMP in Domestic Western Pharmaceuticals Manufacturers |
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作 者 | 陳映樺; 黃琴喨; 李明鑫; 陳柏諭; 陳惠芳; | 書刊名 | 食品藥物研究年報 |
卷 期 | 1 2010.11[民99.11] |
頁 次 | 頁299-308 |
分類號 | 418.61 |
關鍵詞 | 藥品優良製造規範; 西藥製劑藥廠; Good manufacturing practice; PIC/S GMP; Western pharmaceuticals manufacturers; |
語 文 | 中文(Chinese) |
中文摘要 | 摘 要 在全球化市場的趨勢下,藥品管理法規亦朝國際協和與一致化,為提升我國製藥產業 之國際化,衛生署於民國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,並於98年7月30日發函說明相關執行配套措 施,訂於104年1月1日起全面完成實施。為了解國內GMP藥廠執行PIC/S GMP之情形,本研 究以問卷調查方式,分別於97年及98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,並提供政策執行成效評估之參考。 97年對於國內藥廠執行PIC/S GMP狀況之調查結果,藥廠自評廠內作業已完全符合 PIC/S GMP者有12家,近90%藥廠表示需要加強軟、硬體設施的改善,少部分無法符合之 廠商大多表示擬改採委託製造或停止生產部分產品。98年調查國內藥廠自評全面符合PIC/S GMP時程,已有15家藥廠提出PIC/S GMP符合性評鑑申請,91%的業者願意配合實施PIC/S GMP之時程,進行相關改善作業,更有118家藥廠(佔77.1%)可提前於100年底提出PIC/S GMP評鑑申請。由調查結果我們可知國內藥廠大部分皆已配合公告時程規劃與執行PIC/S GMP,政府與業界合作下,將可順利全面完成實施國際GMP,將我國GMP管理推向新的里 程碑,以達消費者、製藥產業及政府三贏之局面。 |
英文摘要 | ABSTRACT The implementing timeframe of the international Good Manufacturing Practice standard (i.e. PIC/S GMP) was announced at December 19, 2007 by the Department of Health, Taiwan. The PIC/S GMP standards are used as the basis for inspections since January 1st, 2010, and all western pharmaceuticals manufacturers should be inspected to compliance with the PIC/S GMP by the end of 2014. In order to be acquainted with the implementing condition of PIC/S GMP in domestic western pharmaceuticals manufacturers, the surveys were carried out respectively in 2008 and 2009 using the questionnaires by inquiring into the compliance status and timetable for completely compliance with PIC/S GMP. The survey result of PIC/S GMP compliance status in 2008 showed that 12 western pharmaceuticals manufacturers considered themselves complied with the PIC/S GMP. Around 90% of western pharmaceuticals manufacturers considered themselves in need to upgrade their manufacturing facilities, equipments and system. Few western pharmaceuticals manufacturers, which considered themselves may not comply with PIC/S GMP, was planning to contact manufacturing or stop production of certain products. The survey result of timetable for complete compliance with PIC/S GMP in 2009 showed that 91% of western pharmaceuticals manufacturers were willing to follow the announced timeframe to upgrade their facilities and system. Besides the fifteen western pharmaceuticals manufacturers which have applied the assessment/inspection of PIC/S GMP compliance, 77.1% of western pharmaceuticals manufacturers indicated they are going to apply the assessment/inspection of PIC/S GMP compliance before the end of 2011. In conclusion, the survey result 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 reach the win-win status of consumer, pharmaceutical industry and government. |
本系統中英文摘要資訊取自各篇刊載內容。