FDA draft process validation update

The US Food and Drug Administration (FDA) has finally issued a draft guidance on process validation, updating its 1987 document. Risk management and quality system tools and concepts form part of the FDA’s new thinking, which is in keeping with its initiative entitled “Pharmaceutical CGMPs for the 21st Century – A Risk-Based Approach”.

Covered under the guidance are some general considerations for process validation, such as having an integrated team that has members with a variety of specialisations, and more specific recommendations, especially when it comes to assessing and mitigating risk. 

The draft guideline is applicable to biological products, active pharmaceutical ingredients (APIs) and drug manufacturers who should align their process validation activities with the product lifecycle concept and existing FDA guidance. The Product Quality Lifecycle initiative (PQLI) is an initiative by the ISPE where validation starts at product development. This aligns with the principles of ICH Q8, Q9 and Q10.  

The FDA now defines process validation as “the collection and evaluation of data, from the process design stage throughout production, which establishes scientific evidence that a process is capable of consistently delivering quality products.”

These recommendations span the three stages covered by process validation, namely process design, process qualification and continued process verification. The three stages cover the adoption of process validation from development and scale-up through to commercial manufacture and beyond to provide ongoing assurance.

Included in the document are sections covering capturing process knowledge and understanding and facility design and equipment selection.