欧盟药品管理规则第4卷：人用和兽用药品良好生产规范欧盟指南（中英文）
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EN EN
EUROPEAN
COMMISSION
Brussels, 22.8.2022
C(2022) 5938 final
GUIDELINES
The Rules Governing Medicinal Products in the European Union
Volume 4 EU Guidelines for Good Manufacturing Practice for Medicinal Products for
Human and Veterinary Use
EN EN
欧洲联盟委员会
2022年8月22日，布鲁塞尔
C（2022）5938终版
指南
欧盟药品管理规则第4卷：人用和兽用药品良好生产规范欧盟指南
1
The Rules Governing Medicinal Products in the European Union
Volume 4 EU Guidelines for Good Manufacturing Practice for Medicinal Products for
Human and Veterinary Use
Annex 1
Manufacture of Sterile Medicinal Products
Legal context for publishing the detailed guidelines: Article 47 of Directive 2001/83/EC
on the Community code relating to medicinal products for human use and Regulation 2019/6
on the Community code relating to veterinary medicinal products. This document provides
technical guidance on the principles and guidelines of good manufacturing practice (GMP)
for medicinal products as laid down in Commission Directive (EU) 2017/1572 for medicinal
products for human use, Directive 91/412/EEC for veterinary use, and Commission
Delegated Regulation (EU) 2017/1569 for investigational medicinal products for human use
and arrangements for inspections supplementing Regulation (EU) No 536/2014 on clinical
trials.
This Annex is intended to assist national authorities in the application of the EU legislation.
Only the Court of Justice of the European Union is competent to authoritatively interpret
Union law.
Status of the document: Revision of the 2007 version of Annex 1.
Document History
Previous version dated 30 May 2003, in operation since
September 2003
Revision to align classification table of clean rooms, to
includeguidance on media simultations, bioburden
monitoring and capping of vials
November 2005 to December 2007
Date for coming into operation and superseding
01 March 2009/01 March 2010
Note: Provisions on capping of vials were
implemented on 01 March 2010.
Reasons for changes: The GMP/GDP Inspectors Working Group and the PIC/S Committee
jointly recommend that the current version of annex 1, on the manufacture of sterile
medicinal products, is revised to reflect changes in regulatory and manufacturing
environments. The new guideline should clarify how manufacturers can take advantage of
new possibilities deriving from the application of an enhanced process understanding by
using innovative tools as described in the ICH Q9 and Q10 guidelines.
The revision of Annex 1 should also take into account related changes in other GMP chapters
and annexes as well as in other regulatory documents. The revised guideline will seek to
remove ambiguity and inconsistencies and will take account of advances in technologies.
Deadline for coming into operation:
- 25 August 2023 : one year from the date of publication in Eudralex Volume 4
- 25 August 2024 : two years from the date of publication in Eudralex Volume 4 for
point 8.123
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作者：薛定谔的龙猫
分类：法规规范
价格：100质量币
属性：118 页
大小：1.81MB
格式：PDF
时间：2025-11-19
