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Posts tagged ‘Eudralex’

New structure to EU GMP

March 28, 2012

Dominic Parry

The structure of European Union (EU) GMP has been adjusted slightly as can be seen from the EUDRALEX web-site. A new Part 3 has recently been introduced.  For some time now GMP has been split into 2 Parts. Read more

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? Read more
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