The GMP environment is currently changing. Not only the US Food & DrugAdministration modifies its GMP regulations, but also the European MedicinesAgency (EMEA) has taken up an ambitious revision programme for this year (seealso GMP-News from 2 November 2007). As an “outcome” the EMEA recentlyissued the drafted revision of the Annex 2 of the EC GMP Guide for (seealso GMP-News from 9 October 2007).
The draft clearly shows the modern GMP aspects incorporated –as, for instance, risk management. ICH Q9 (Quality Risk Management) is currentlydiscussed everywhere. The EC GMP Guide chapter 1 was modified accordingly, andthe Community Procedures are currently revised with regard to risk managementalso. ICH Q9 itself will supposedly be implemented as Annex 20.
The draft of Annex 2 now also reinforces the requirement for risk baseddecisions. This affects for example
- The access of personnel in the manufacture of biotechproducts,
- The management of aseptic processes and
- Tests with regard to cross contamination.
Other changes currently discussed apply to the EC GMP Guidechapters 3 and 5 concerning “dedicated facilities/dedicated equipment”. TheAnnex 2 draft requires e.g., to take “dedicated equipment/facilities“ intoaccount to be able to reproduce products and avoid cross contaminations. Riskmanagement is present here as well. It also addresses a possible conflict withrequirements regarding work safety. In the changes to the chapters 3 and 5themselves risk management will also be a main focus.
A well-known issue – validation/qualification – will still remain. For instance,the draft addresses validation-related requirements like
- Validation of decontamination,
- Validation of air vent filters (for their life span
- Processes validation (specifically mentioned are allergenand recombinant products, monoclonal anti bodies and gene therapeutics
- Validation of sterilisation, disinfection, virus removaland –inactivation
- Requalification of the irradiation
- Validation of hold time
- Validation of purification
- Cleaning Validation (specifically mentioned are genetherapeutics)
The Annex 2 draft can be used as indicator for “modern GMP”.The trend clearly goes toward risk based decisions which the authorities demandfrom pharmaceutical companies – however, paying attention tovalidation/qualification at the same time though.
Get answers to still many open questions with regard tocleaning validation in the 2-day education course Cleaning Validation in Vienna,Austria, from 27-28 May 2008.
International Bio-Conference BioProduction Forum – Fill and Finish for Biopharmaceuticals in Schaffhausen, Switzerland, from 28-30 November 2007.
On behalf of the European Compliance Academy (ECA)