EU Product Quality Review now also part of WHO GMP main Principles

The WHO Expert Committee on Specifications for Pharmaceutical Preparations met in Geneva from 18 to 22 October 2010. Now, the respective report has been submitted to the WHO Executive Board and was published:

"Proposals for updating the WHO GMP main principles were discussed at various informal consultations and received as feedback to the increased implementation of this text. Discussions during the consultation on WHO guidelines for medicines quality assurance, quality control laboratories and transfer of technology on 27-31 July 2009, revealed the need to incorporate a new section (1.6) on "Product quality review" under Chapter 1: "Quality assurance" in the WHO good manufacturing practices (GMP): main principles for pharmaceutical products."

"The Expert Committee agreed to update the guidelines accordingly and recommended publication of the entire guidelines as an Annex to its report in order to replace the one previously published as Annex 4, WHO Technical Report Series, No. 908 in 2003 (Annex 3)."

The new chapter 1.6 equals (besides some minor editorial changes) chapter 1.4 on Product Quality Review of the EU-GMP Guide.

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