EMA revises its Process Validation Guidelines

At the end of February 2010, the European Medicines Agency (EMA) published a draft paper revising their process validation guidelines (Note for Guidance on Process Validation), which have been in effect since 2001. Their aim is to update the guidelines to fit in with the state of present-day technology. Elements from the guidelines ICH Q8 (Pharmaceutical Development), ICH Q9 (Quality Risk Management) and ICH Q10 (Pharmaceutical Quality Systems) are to flow in, particularly in the process areas of Analytical Technology (PAT), Quality by Design (QbD) and Real Time Release Testing (RTRT).

The EMA would particularly like to integrate modern aspects ("enhanced approach") into the guidelines, and names expressly the "continuous process verification" (with reference to ICH Q8 (R2)) in connection with a steady improvement process ("continual improvement"). The product life cycle is its main focus. In contrast, there are the (present) current guidelines. These lay their emphasis mainly on the validation batches and the verification of a validation process. Another aspect regarding the changes is mentioned: The Harmonisation with the FDA Draft Guidance on Process Validation. It is expressly mentioned here that any changes made will have no effect on products currently on the market. The aim is to demonstrate to companies some new potentialities regarding process validation, and in addition, to provide for more (regulatory?) flexibility within the industry.

The high importance of the revision is demonstrated when one considers the parties involved. The development of the new guidelines adopts the Quality Working Party, in cooperation with the EU / EEA authorities, the Inspectors Working Group, the EMA PAT Team, the Biologics Working Party (BWP), the Immunologicals Working Party (IWP) and the Herbal Medicinal Products Committee (HMPC).

It is planned that the final document will be ready in the 4th quarter of 2011.

Conclusion: Fortunately, the EMA is following suit, as far as the modern aspects of process validation are concerned. The FDA, with their draft review of their own 1987 Process Validation Guidance (still current), really "widened the gap", in comparison to the EU. With their draft paper, the EMA has succeeded in closing "the gap" substantially. The perceptions concerning process validation in the USA and Europe are going in the same direction.

You can find this document here.

PS. At the ECA event "The New FDA/EU Approach to Process Validation" in Prague, Czech Republic, on 8-9 June 2010 an EU-Inspector will be reporting regarding the latest trends on the subject of process validation. And the FDA is also invited...

Author:
Sven Pommeranz
On behalf of the European Compliance Academy (ECA)

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