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EMA publishes New Process Validation Guideline - 16 Mar 2014

The European Medicines Agency recently initiated the revision of its process validation guideline and published the final document on 27 February 2014.  The revision was initiated to enable the guideline align closely with the modern GMP concepts with the following objectives:

The original 7-page long Note for Guidance on Process Validation has more than doubled to 15 pages.  The change in the title to "Guideline on process validation for finished products- information and data to be provided in regulatory submissions" is one obvious and noticeable change.  The document title itself gives some indication to the content of the guideline, namely marketing authorisation matters.

The document has eight (8) chapters, a summary, definitions, references, an Annex I (Process validation scheme) and an Annex II (Standard/non-standard processes).  A sub section on "Design space verification" has also been included to the document in the chapter on process validation.

The main changes in this document compared to the currently applicable Note for Guidance on Process Validation are highlighted below;

Primarily this guideline is a marketing authorisation document, as addressed in the title, and applies to finished dosage forms of chemical medicinal products for human and veterinary use.  It does not impact old products which are already authorised and on the market.  A further change is the introduction of a validation life cycle and the integration of continued process verification (CPV). Although these concepts are completely new to the guidance document, they are already established concepts in ICH Q8.  

A stronger overlap of the FDA Guidance would have been desirable.  The FDA's Guidance addresses APIs and biologicals, and also contains GMP aspects.  In addition, the FDA Guidance explicitly addresses old products which should be integrated to stage 3 of the life cycle.  Unlike the FDA guidance, the revised document doesn't highlight statistical methods.

The new EMA guideline on process validation will come into force by the end of August 2014.

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