WHO proposes new Sections for Guideline on Quality Assurance Topics

The World Health Organisation has proposed new sections for the WHO Good Manufacturing Practices (GMP): Main Principles for Pharmaceutical Products.

A new section (1.4) on "Product Quality Review" has been incorporated in Chapter 1 "Quality Assurance". In addition, several updates have been suggested to further enhance and include the concept of risk management, replace "drugs" by the new terminology "medicines" and newly include the concept of a "Quality Unit" with defined responsibilities for this unit but also for the Head of the Quality Unit, like (personal) participation in external audits. The responsibilities of the Head of the Quality Unit are now distinguished from those of the Authorized Person, who is now per definition responsible for approving a batch release. In this case the proposed WHO guidance is reflecting the EU system of the Qualified Person (QP).

The WHO has now asked ECA to comment the proposed new sections and gave the permission to circulate the document amongst its members. The "WHO proposed new sections for Guideline on QA.pdf" with tracked changes can be found in members' area of the ECA website. The ECA would now like to ask its members to support ECA and send comments to info@gmp-compliance.org, using the "table to use for comments" which can be found on the same webpage. Deadline for comments is 17 September 2010

Please do not send comments directly to WHO.

This draft is intended for a restricted audience (ECA members). The draft should not be displayed on any web site or circulated via e-mail.

Please see the WHO Annex 4: Good Manufacturing Practices for pharmaceutical products: main principles for the details.

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