The UK Medicines and Healthcare products Regulatory Agency (“MHRA”) has published guidance for companies submitting a Manufacturing Authorisation application or variation on...06 January 2017
THE EUROPEAN MEDICINES AGENCY PUBLISHES DRAFT GUIDELINE ON PROCESS VALIDATION FOR BIOLOGICS
This Draft Guideline provides guidance on the process validation of biotechnology-derived proteins used as active substances in the manufacture of medicinal products. The Draft Guideline also determines the validation data to be submitted as part of an application for marketing authorisation or variation of an existing authorisation for a medicinal product.
The Draft Guideline applies to recombinant proteins and polypeptides, their derivatives, and products of which they are components (for example, conjugates) and other biological products such as vaccines or blood products, as appropriate. In addition, the Draft Guideline advises pharmaceutical companies to consult with the appropriate competent authorities to determine if the provisions of the Draft Guideline are applicable to the company's biological product.
Pharmaceutical companies interested in submitting comments on the Draft Guideline may submit their comments to BWPSecretariat@ema.europa.eu using the template which is referenced in the Draft Guideline.
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