Revision of EC Guide to GMP Proposed for Comment
The new consultation is a concept paper on revisions to Chapter 8 of the GMP Guidelines on Complaints and Product Recall.
The European Medicines Agency (EMA) has issued new consultation on various aspects of revision of the EU Guidelines on Good Manufacturing Practice (GMP) for medicinal products. The new consultation is a concept paper on revisions to Chapter 8 of the GMP Guidelines on Complaints and Product Recall.
Among the proposals for comment in the paper are:
?A recommendation that the current version of Chapter 8 be revised to introduce the need for Quality Risk Management principles and appropriate root cause analysis work to be applied when investigating quality defects/complaints and when making decisions in relation to product recalls or other risk-mitigating marketplace actions.
?A recommendation that the current Chapter 8 wording in relation t
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