A concept paper has been published by the Biologics Working Party (BWP) of the EMA about the need for a guideline on process validation of medicinal products containing biotechnology derived proteins as active substance.
The working party stated that even though guidelines related to the quality of biotechnological/biological products have been developed at the EU level, and several documents have been harmonized through the ICH process, those documents do not satisfactorily address the specific aspects of validation and evaluation for biotechnology derived products.
Specifically, the BWP recommends developing a guideline on the guideline should focus on data requirement for process validation/evaluation for submission of a marketing authorization application or variation. It is anticipated that the draft guideline will be released for consultation in the first quarter of 2012, followed by a six month external consultation period prior to finalization of the document.