Revision of EU GMP Guidelines

by Robert M. Tribe

Background

The EMEA announced on 18 February 2008¹ several significant revisions to the EU Guidelines to Good Manufacturing Practice for Medicinal Products for Human and Veterinary Use (EU GMP Guidelines). These included revisions to Part I, Chapter 1 (Quality Management) and Annex 1 (Manufacture of Sterile Medicinal Products), as well as the inclusion of a new Annex 20 on Quality Risk Management.

Revision of Part I, Chapter 1 on Quality Management

Part 1, Chapter 1 of the EU GMP Guidelines has been revised to include a section on quality risk management and the importance of this being an integral part of a manufacturer's quality system².

This revision is part of the European Commission's policy to endorse and implement the ICH Q9 guideline on quality risk management³. A similar approach is likely to be followed in a future revision of Part II of the EU GMP Guidelines covering active pharmaceutical ingredients.

The new section on quality risk management makes reference to a new Annex 20⁴ which has been added to the EU GMP Guidelines; this new Annex is essentially a copy of the ICH Q9 guideline on quality risk management.

Additional background information on this revision and the Annex 20 is provided in the revised Introduction⁵ to the EU GMP Guidelines.

The revised version of Part 1, Chapter 1 of the EU GMP Guidelines will come into operation on 1 July 2008.

Revision of Annex 1 – Manufacture of Sterile Medicinal Products

Annex 1 to the EU GMP Guidelines, covering sterile medicinal products, was revised and updated after a long consultation period⁶. This revision was necessary in particular to align the classification table for environmental cleanliness of clean rooms to the relevant ISO standards.

Annex 1 has been revised and updated in four main areas:

Classification table for environmental cleanliness of clean rooms, and associated text.
Guidance on media simulations.
Guidance on bioburden monitoring.
Guidance on capping of freeze-dried vials.

This revised Annex 1 will come into operation on 1 March 2009 except for the provisions on capping of freeze-dried vials, which should be implemented by 1 March 2010.

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About the Author
Bob Tribe is ISPE’s Regulatory Affairs Advisor for the Asia Pacific, based in Canberra, Australia. He joined ISPE from the Therapeutic Goods Administration (TGA) in Australia, where he served as Chief GMP Auditor for 23 years. During that time, he not only enhanced the TGA’s reputation as a leading GMP regulator internationally but also held leadership positions with the Pharmaceutical Inspection Cooperation Scheme (PIC/S), serving as vice chairman in 1998-1999 and chairman in 2000-2001. Recently, Tribe founded a company to provide consulting to GMP regulatory authorities around the world.