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EU GMP: Final Annex 15 now published
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News about GMP/cGMP


EU GMP: Final Annex 15 now published

The currently valid version of the EU GMP Guide  Annex 15 “Qualification and Validation” from 2001 will finally be replaced by 1 October 2015. This is when the now published revised Version of Annex 15 will enter into force. An update was more than necessary. Not only the new principles of ICH Q8, Q9, Q10 and Q11 constituted a new regulatory environment but also a continuous updating of Chapters of Part I of the EU GMP Guide or Annex 11 (computerised systems). Another important document to be mentioned in connection with the new Annex 15 is the EMA guidance on process validation. The changes now reflect the changed regulatory requirements and the latest state of technology in the pharmaceutical industry.


Here are some of the modifications compared to the draft document:

  • Under the section “Principle” it was added that the new Annex 15 may also be used as supplementary optional guidance for active substances without introduction of additional requirements to EudraLex, Volume 4, Part II.
  • As stated in the section “General”, retrospective validation is no longer considered an acceptable approach.
  • The term “validation” has been consequentially replaced with “qualification and validation” (e.g. 1.2. – 1.5.).
  • Under 1.5 the mention of an “ongoing validation strategy” has been removed, also the mention of an assessment of the required resources.
  • A new point 1.8. concerning the integrity of data has been added.
  • Under 3.4. “Factory Acceptance Testing (FAT) equipment, especially if incorporating novel or complex technology, now “may” and not “should” be evaluated, if applicable, at the vendor prior to delivery.
  • “Re-Qualification”, formerly specified under point 10, is now listed under point 4.
  • The “ongoing process verification” has to be based on an equivalent documentation.
  • Under 5.4. and 5.5. a bracketing approach is now mentioned as a possibility to reduce the number of validation batches.
  • Compared to the draft the final version of Annex 15 now also requires the qualification of equipment for secondary packaging (7.1.).

Basically it can be stated that the final version of Annex 15 holds no surprising amendments compared to the draft version. All those who have already taken a closer look at the draft of Annex 15 are well prepared and can now concentrate on putting theory into practice.


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