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EC publishes trio of revised GMP Guide sections

Published on 24/09/12 at 01:40pm

The European Commission has published two revised chapters in its Good Manufacturing Practice (GMP) Guide, along with an update of Annex 2 on biologic active substances, to bring guidelines into line with current practices.

The revised chapters of the EU-GMP Guide are Chapter 1 - formerly called Quality Management and now renamed Pharmaceutical Quality Systems - and Chapter 7 on Outsourced Activities.

Chapter 1 has been renamed and amended to align with the International Conference on Harmonization (ICH) Q10 document, which was finalised in 2008, according to the EC.

ICH Q10 was designed to provide a framework for a harmonised pharmaceutical quality system applicable across the lifecycle of a product and resting on an integrated approach to quality risk management and science, and the new Chapter 1 has had to undergo comprehensive changes to avoid discrepancies.

The revisions introduce a number of new concepts into the Guide, including expressly placing responsibility for quality on senior management and requiring management review to identify how processes can be continuously improved. It also makes the development of a quality manual mandatory for the first time.

Chapter 7 on Outsourced Activities has been revised to provide "updated guidance on outsourced GMP regulated activities beyond the current scope of contract manufacture and analysis operations", according to the EC. Some of the changes have also become necessary because of the introduction of ICH Q10.

Once again the title of the document has been changed (from Contract Manufacture and Analysis) and the revisions make explicit recommendations about the responsibilities of the issuer and receiver of the contract. It also specifies what should be covered in a contract, including auditing permissions.

Finally, Annex 2 on the manufacture of biological active substances has been revised "as a consequence of the restructuring of the GMP Guide [and] new manufacturing technology and concepts", says the EC.

One of the primary drivers for the update is greater variety of biological medicinal products coming onto the market, such as transgenic derived products and gene- cell- and tissue-based therapies that are collectively known in the EU as advanced therapy medicinal products, (ATMPs).

All the revisions will come into force on 31 January, 2013.

Phil Taylor

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