Implementation of Modern GMP Aspects: Revision of the Annex 2 of the EC GMP Guide as an Example
The draft clearly shows the modern GMP aspects incorporated
as, for instance, risk management. ICH Q9 (Quality Risk Management) is currently
discussed everywhere. The EC GMP Guide chapter 1 was modified accordingly, and
the Community Procedures are currently revised with regard to risk management
also. ICH Q9 itself will supposedly be implemented as Annex 20.
Other changes currently discussed apply to the EC GMP Guide
chapters 3 and 5 concerning dedicated facilities/dedicated equipment. The
Annex 2 draft requires e.g., to take dedicated equipment/facilities into
account to be able to reproduce products and avoid cross contaminations. Risk
management is present here as well. It also addresses a possible conflict with
requirements regarding work safety. In the changes to the chapters 3 and 5
themselves risk management will also be a main focus.
The Annex 2 draft can be used as indicator for modern GMP. The trend clearly goes toward risk based decisions which the authorities demand from pharmaceutical companies however, paying attention to validation/qualification at the same time though.