Title

醫用氣體GMP管理之研究

Translated Titles

The Study of GMP Management in Medicinal Gases

DOI

10.6945/ARFDR.201112.0047

Authors

李思鈺(Szu-Yu Lee);趙永康(Yung-Kang Chao);謝文豪(Wen-Hao Hsieh);陳映樺(Ying-Hua Cheng);黃琴喨(Chyn-Liang Huang);李明鑫(Ming-Shin Lee);陳惠芳(Hwei-Fang Cheng)

Key Words

醫用氣體 ; 藥品優良製造規範 ; 國際醫藥品稽查協約組織 ; medicinal gases ; Good Manufacturing Practice (GMP) ; The Pharmaceutical Inspection Convention and Pharmaceutical Inspection Co-operation Scheme (PIC/S)

PublicationName

食品藥物研究年報

Volume or Term/Year and Month of Publication

2期(2011 / 12 / 08)

Page #

45 - 50

Content Language

繁體中文

Chinese Abstract

隨著政府推動國際GMP標準(PIC/S GMP),國內製藥產業之水準皆已朝與國際一致化之目標前進。如今,政府為了更嚴格把關國民之用藥安全,於民國100年1月6日公布了「醫用氣體製造工廠實施藥品優良製造規範之方法及時程」,自101年1月1日起,凡新設、遷移及新查驗登記申請案之醫用氣體製造工廠應符合「藥物製造工廠設廠標準-第三編第一章西藥藥品優良製造規範」之規定;已領有藥品許可證之醫用氣體製造工廠,需於102年12月31日前全面完成實施GMP。至100年5月底止,共有42家醫用氣體製造工廠已完成100張醫用氣體藥品許可證之查驗登記,其中已有2家醫用氣體製造工廠提出GMP評鑑申請。從過去推動輔導結果可知,國內大部分醫用氣體製造工廠皆有意願配合政府推動醫用氣體GMP管理,在政府與業界之通力合作下,相信將可順利完成實施,把我國之GMP管理推向新的里程碑,以達到消費者、製藥產業以及政府三贏之局面。

English Abstract

The domestic pharmaceutical industry has already progressed towards international standard because of the promotion of PIC/S GMP guide by the relevant authority. Nowadays, the relevant authority has announced ”the implementing timeframe of Good Manufacturing Practice (GMP) for medicinal gas manufacturers” in January 6, 2011 to strictly protect public health and safety. After January 1, 2012, new established and relocated factories, and newly registered manufacturers should comply with the standards for establishment of pharmaceutical manufacturers. The medicinal gas manufacturers which own manufacturing licenses should be confirmed with its GMP compliance status before December 31, 2013. Since May 31, 2011, 42 medicinal gas manufacturers have completed the registration of 100 medicinal gas manufacturing licenses, and two of them have already applied for GMP assessment. According to the former assistant report, most of the medicinal gas manufacturers will follow the GMP policy in medicinal gases. The cooperation of industry and regulator shall accelerate to completely comply with international GMP, cross a new milestone of pharmaceutical manufacturing authorization system, and attain the win-win status of consumer, pharmaceutical industry and government.

Topic Category 醫藥衛生 > 藥理醫學