IGMPI India

EMA has revised its process validation guideline after the publication of the Annex 15 draft at the beginning of February 2014. The EMA had already announced this revision in a concept paper from long time. The objective of the revision was to incorporate modern GMP aspects:

•  Integration of the ICH Q8, Q9 and Q10 Guidelines
•  Incorporation of Process Analytical Technology (PAT), Quality by Design (QbD) and Real-Time Release Testing    (RTRT).
•  Extension with regard to an "enhanced approach" and integration of "continuous process verification"
•  Integration of the Annexes to the current Note for Guidance
•  Harmonization with the current FDA Guidance on Process Validation

The previous title “Guidance on Process Validation” has been replaced by "Guideline on process validation for finished products- information and data to be provided in regulatory submissions". A sub section on "Design space verification" has been newly added to the chapter on process validation and the chapter of ongoing process validation has been removed.

A stronger overlap of the FDA Guidance would have been desirable. FDA's Guidance also deals with APIs and biologicals, and the process validation life cycle runs like a thread through the whole FDA document. It also contains GMP aspects. The FDA Guidance explicitly addresses old products which should be integrated to stage 3 of the life cycle. Yet, there is another big difference. The revised document doesn't highlight statistical methods like the FDA Guidance.

The new EMA guideline on process validation will apply by the end of August 2014. View full guidance Click here