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EMA Guidelines on Process Validation Filings for Biotech Substances and Drug Products Advancing Along with GMP Annex 15 Revision

Feb 12th, 2013

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A guideline on what the European Medicines Agency (EMA) wants to see in marketing authorization applications (MAAs) regarding process validation for biotech drug substances is advancing as a third prong in the agency’s effort to strengthen its PV guidance portfolio.

Also moving through the EMA pipeline is a guideline on drug product process validation filing expectations and a revision of Annex 15, which addresses process validation from a GMP vantage point.

The biotech guide, being developed by EMA’s Biologics Working Party (BWP), will instruct industry on how to submit key information related, for example, to: ● process and product-related impurity clearance such as host cell proteins and DNA ● column and membrane sanitization and life time ● hold times ● reprocessing ● pooling of intermediates, and ● selection of batches to be included in evaluation and validation batches.

A concept paper on the need for a guideline on “process validation of medicinal products containing biotechnology derived proteins as active substance” was released for a three-month public consultation in May 2011.

Further industry input into the drafting process will be gathered at an agency/industry meeting to be held at EMA headquarters in London in April.  The meeting will focus on specific topics for which the BWP would like further input.

At a CASSS CMC Strategy Forum on biotech process validation held in Washington, D.C. in late January, Medical Products Agency Senior Expert and BWP member Mats Welin discussed the progress made to date on the preparation of the guideline, which he said is expected to be released for public consultation in the third quarter of 2013 (see box below).

Welin stressed that his working group has “no intention to contradict global or regional guidelines.” The objective is to “be in line with the EU draft process validation guideline for drug products, with ICH Q11, US guidances and other GMP documents,” he said.  And the BWP is “open for discussion on how to make sure that we are not creating double standards and double work.”

Welin also stressed that the BWP has “no intention of increasing the requirements” for process validation information in applications, “but instead, of clarifying expectations to see that people get it right the first time it is submitted.”

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