Guideline on Process Validation for Manufacturing of Biotechnology-Derived Active Substances

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Are you up to date on process validation requirements for the manufacture of biotechnology-derived active substances and data to be provided in the regulatory submissions for the EU?  Process validation is the documented evidence that the process, operated within established parameters, can perform effectively and reproducibly to produce an active substance or intermediate meeting its predetermined specifications and quality attributes (ICH Q7).

The EMA just published a new guideline that addresses the data requirements for process characterization and verification for submission of a marketing authorization application or variation.

These principles apply to recombinant proteins and recombinant polypeptides, their derivatives, and products of which they are components (e.g. conjugates). This guideline discusses process characterization and process verification requirements.  It also includes points to consider such as evaluation and verification of the upstream and downstream processes, issues related to single use equipment and multiple harvests, reprocessing, hold time, storage, transportation, and multi-facility production.

Download the full guidance here.