CMDh and other updates – August 2022

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
Revision to Annex 1: Manufacture of Sterile Medicinal Product

Volume 4 of “The rules governing medicinal products in the European Union” contains guidance for the interpretation of the principles and guidelines of good manufacturing practices for medicinal products for human and veterinary use laid down in Commission Directives 91/356/EEC, as amended by Directive 2003/94/EC, and 91/412/EEC respectively.

Annex 1 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.

Reason for revision to Annex 1: 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

Source: European Commission

Step 2 no nitrosamine detected response template

The above template has been updated and the version of August 2022 Rev,2 can be downloaded here.

Source: Heads of Medicines Agencies