EMA publishes a draft Guideline on Process Validation of Biotechnology-Derived products

The EMA has published the draft entitled as “Guideline on process validation for the manufacture of biotechnology-derived active substances and data to be provided in the regulatory submission”.

It is the second validation document published by the EMA within a short period of time. This draft on process validation of biotechnology-derived products depicts the data required for submission of a marketing authorization application or variation to be submitted for the validation of biotechnology-derived proteins used as APIs in the manufacture of medicinal products. This guideline deals with process evaluation and verification studies for the upstream and downstream process, in the context of a marketing authorisation application or a variation application, if relevant. A traditional approach or an enhanced approach to process validation, or a combination of both can be used. The document is divided into 6 chapters:

1. Introduction
2. Scope
3. Legal basis
4. Process development
5. Process validation
- Process evaluation
- Process verification
- Ongoing process verification
6. Points to consider in process validation
- Upstream process
- Downstream process
- Multifacility production