EMA publishes Concept Paper on the Revision of Annex 15

In November 2012, the EMA released a Concept Paper of 3 pages on the revision of Annex 15. The introduction presents the reasons why the EMA has planned the revision: significant changes in the GMP environment since the publication of Annex 15 in 2001. The ICH Q9 und Q10 guidelines, Process Analytical Technologies (PAT) and the concept of continuous manufacture are explicitly mentioned to be integrated into the revision. Further aspects to integrate concern the revision of EMA's Guideline on Process Validation (see our GMP News from 23 May 2012) and changes to the EU GMP Guide itself.

The chapter "Discussion" of the Concept Paper clearly points out that the concept of risk assessment has already been part of the current version of Annex 15. Yet, the topic has been expanding with the introduction of ICH Q9 and should be respectively integrated in the revision. The revision of EMA Guideline on Process Validation is also mentioned (integration of ICH Q 8, 9, 10). In so far, the questions of "continuous process verification" and an "enhanced approach" in the development environment should be taken into consideration for the revision of Annex 15 too.

The following elements are among the changes to the EU GMP Guide to be considered for the revision of Annex 15:

  • Chapter 1 of the GMP Guide on Change Control
  • Implication of PQR on validation activities
  • Planned changed regarding "dedicated facilities" in Chapters 3 and 5
  • Revised Annex 11

Guidance issued by other regulatory agencies (like WHO and FDA) will be considered as far as possible. Also the question of transport validation will be taken into consideration. According to the Concept Paper, further guidance is planned to be added to the sections on documentation and validation types (including transfer validation) and qualification of equipment.

The following timetable has been planned:

  • Deadline for comments to the Concept Paper: February 2013
  • Proposed date for release of draft guideline: December 2013
  • Deadline for comments to the draft guideline: March 2014
  • Expected date for adoption of the revised Annex 15: October 2014

The chapter entitled "Resource requirement for preparation" mentions the intervention of a rapporteur from the UK who will be supported by experts from other EU competent authorities (including Ireland, Germany, Italy and Portugal) and also from a non-EU but PIC/S participating authority (Canada). Interestingly, the document says that no adverse impact on industry in terms of resources or costs is foreseen.

Conclusion: The Concept Paper on the revision of Annex 15 remains rather vague. Elements from the ICH Q8, 9 and 10 should be incorporated as well as changes to the EU GMP Guide. Harmonisation with other validation guides (e.g. WHO and FDA) as well as with the revision of EMA's Guideline on Process Validation should - logically - also be achieved. That Annex 15 is being updated is good news. If this revision could come together with the revision of EMA's Guideline on Process Validation, this would be even better news. Unfortunately, it seems like the revision will be published much later than the final revision oft he Process Validation Guideline. It will be interesting to see whether there will be no adverse impact on industry in terms of resources or costs.

PS: At the 5th European GMP Conference on 6/7 June 2013 in Heidelberg, you will be invited to work on the further development of ECA's Good Practice Guide on Process Validation together with ECA's Interest Group Process Validation. The Guide shows how modern process validation (including qualification) could look.

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