Tuesday, October 17, 2017
Project co-funded by the European Commission in the framework of the 2nd Health Programme
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4.8.2 Risk management in relation to GMP/GTP

GMP for pharmaceuticals has now officially been enhanced with annex 20 for Quality Risk Management. It is increasingly acknowledged as important to perform formal documented risk assessments.

Annex 20 lists a description of various models. Annex 20 also lists potential applications for quality risk management.

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