EMA Process Validation Draft Targets Filing Requirements and Assessor Needs

The European Medicines Agency (EMA) has released a draft process validation (PV) guideline that mirrors FDA’s PV guide in principle, but is aimed more at the content and assessment of marketing authorization applications rather than the execution of validation in a manufacturing facility.

The 11-page draft covers process validation for drug products for both human and veterinary medicines, excluding legacy products, and is out for comment until the end of October.

The draft guide explains that its fundamental principles “are applicable to biological products,” but that “these should be considered on a case-by-case basis in view of the complex nature and inherent variability of the biological substance.”  EMA is working on a separate guidance that will address process validation issues specific to biotech products, which is expected to be released soon.  [Editor’s Note:  A discussion of EMA’s biotech PV effort will forthcoming].

FDA states in its process validation guidance that it does encompass biotech products, and the agency is not working on a separate biotech-specific document.

At a CASSS European CMC Strategy Forum in Berlin, Germany in late April, Kowid Ho, a biotech products assessor for AFSSAPS and a member of EMA’s Biologics Working Party (BWP), explained that a primary intent of the draft is to identify what assessors want to see in the MAA regarding process validation and that it is not prescriptive regarding how to conduct the validation.

“We are trying to provide some clarification on the data expected in the dossier,” he commented.  “This is something that helps you understand what we need to see in the filing.  It is not to tell you how to validate it.”

As a reviewer, he explained, “I will certainly not tell you how you should validate it, particularly when I see how different companies’ approaches to process validation are different.  I will not tell you what is the right or wrong approach.  I prefer to tell you what I want to see in a dossier to make me confident that your process is in a validated state.”

[More from Ho on the EMA draft and a comparison with the FDA guideline is available for subscribers here.  Nonsubscribers can purchase the story for $195 by contacting Karen Bertani (Jonathan@ipq.org).  For subscription/license information, click here.]