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Proposed EU GMP Annex 16 update

January 23, 2012

Dominic Parry

The deadline for public comments on the concept paper on revising EU GMP Annex 16 – Certification by a Qualified Person and batch release is due in just a few weeks. Closing date is 31st January 2012.

Problem statements (from the concept paper)

  • What is the minimum a Qualified Person (QP) must personally carry out when certifying a batch?
  • What are the prerequisites for relying on statements from persons other than fellow QPs?
  • How is the Control Strategy and the batch certification release process linked?
  • What are the expectations for QPs reviewing batch records manufactured by third parties in third countries?
  • What knowledge should a QP have about the site(s) involved in the manufacturing of a batch?
  • What actions are expected from the QP when a batch cannot be certified and therefore released?

Click here for a link to the EUDRALEX website.

2 Comments

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  1. February 15, 2012

    Cheers for the information, and the blog honestly looks outstanding. What wordpress design are you employing?

    • Ron Orme #
      February 17, 2012

      Hi, Thanks for comment. Theme is ‘React’.

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