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 Revision to align classification table of clean rooms, to includeguidance on media simultations, bioburden monitoring and capping of vials Date for coming into operation and superseding September 2003 November 2005 to December 2007 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 1
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