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EMA proposes updating EU GMP guide on complaints and product recalls

This article was originally published in SRA

Executive Summary

The European Medicines Agency has proposed updating the European Commission's good manufacturing practice guideline dealing with complaints and product recalls (ie Chapter 8 of EudraLex Volume 4)1. The EMA says the update is needed to reflect that drug manufacturing companies need to apply quality risk management principles when investigating quality defect issues and complaints, and when making decisions in relation to product recalls.

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