Friday 25 April 2014

EU GMP Chapter 6 Updated - Effective from 1st October 2014

The revision of EU GMP Chapter 6 on Quality Control has now been finalised and will be effective from 1st October 2014. The reasons for change on the new document are summarised as: "Inclusion of a new section on Technical transfer of testing methods and other items such as out of specification results."

The finalised document is mostly similar (a few of the proposed changes have not made it in) to the proposed draft that I reviewed in two blog posts last year.

The new section on method transfer is summarised in the first blog:
How does the Update to Chapter 6 of the EU GMP Guidelines Affect Your Lab?

The other updates in Chapter 6 are covered in this follow-up blog post:
How Does the Update to Chapter 6 of the EU GMP Guidelines Affect You? - Part 2

Ensure that you are up to date with the method transfer expectations of EMA, FDA and USP by attending the MTS training course, 'Transfer of Analytical Methods for Pharmaceutical Analysis'. Next opportunity is on the 2nd October 2015 in London. Check out our Course List for details of other dates and locations, and other courses, or contact us for more information.


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