European Commission Releases New GMP Guide Annex 2 for Biologics for Consultation

GMP News
9 October 2007

European Commission Releases New GMP Guide Annex 2 forBiologics for Consultation

An up-dated draft version of Annex 2 was published recently.

With this new document the European Commission pays tribute to significantdevelopments in the field of biologics during the last years:

  • the introduction of GMP for active substances used asstarting materials (Part II of the EU-GMP Guide)

  • the increasing range of biological products

  • the implementation of the new regulations on advancedtherapies including gene therapy, somatic cell therapy medicinalproducts, tissue engineered products.

This short list is reason why the document grew from 5 to24 pages.

On the other hand you may ask the question if this approach to cover thecomplete heterogeneous group of biological products in one single documentcan be successful.

The new annex 2 has been divided into two main chapters:

Chapter A describes general GMP requirements which have to be applied to allbiological products. In its structure this part of the document is verysimilar to the current annex 2. But many of the demands are described inmore detail and new requirements have been added.

Chapter B contains guidance on individual product classes (monoclonalantibody products, somatic and xenogenic cell therapy prodcuts, vaccines...).
Surprisingly the text for tissue engineered products is missing - a class ofbiologicals with impressing advancements during the last couple of years.

Due to the complexity of the comprehensive project the European Commissionallows a remarkably long period for consultation until March 14, 2008.

The reading of the new annex is strongly recommended to all who are involvedin the development, production or quality control of biological products -especially to those colleagues who are engaged in advanced therapies.

Please use this opportunity to forward your comments and suggestions to theEuropean Commissions - ether directly or via those organisations thatrepresent your interests. You have the unique chance to influence thoserequirements that will have a direct impact on you.

You will find the new draft Annex 2 to the EU-GMP Guide at

APIC/CEFIC and the ECA announced the new date for the ICHQ7 Week. The training course "ICH Q7 Compliance for APIs Manufactured byCell Culture/Fermentation" will concentrate on biopharmaceutical APIs. It will take place from 25-27 February 2008 in Berlin, Germany. For detailedinformation please

Dr Ulrich Herber
On behalf of the European Compliance Academy (ECA)


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