ICH Q8-11 Oriented Submission and GMP Expectations for Process Validation and Other Quality Issues Taking Shape in Europe

The effort in Europe to update its expectations for process validation (PV) to reflect the quality management principles underpinning ICH Q8-11 moved closer to completion in late February with the issuance of a final guideline on PV submissions for medicinal products and a draft revision of EU GMP Annex 15.

A draft of EMA’s guideline on what should be submitted in marketing dossiers regarding process validation for finished products was put out for public comment in the spring of 2012 (IPQ May 30, 2013). The final guideline, modified to reflect the numerous comments received on the draft, becomes effective in August.

Annex 15, which addresses the qualification and validation of processes from a GMP vantage point, was last revised in 2001.  A concept paper explaining the motivations for the revision was released by EMA’s GMP/GDP Inspectors Working Group (IWG) in late 2012 (IPQ February 12, 2013). Among them are technology advances, changes to the EU GMPs, the incorporation of ICH Q8-11 principles, and the rewrite of the PV drug product submission guidance. Comments on the Annex 15 revision are due by May 31.

A third EMA PV project is focused on biotech active substances (ibid.).  A concept paper on the need for a biotech guideline was released for a three-month public consultation in May 2011.  Further industry input into the drafting process was gathered at an agency/industry meeting at EMA headquarters in London in mid-2013.  Release of a draft for comment is anticipated this year.

The biotech guide, being developed by EMA’s Biologics Working Party (BWP), will instruct assessors and industry on submission expectations in key areas such as: ● clearance of process and product-related impurities, 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.

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