FDA publishes guidance on process validation
Modern 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”.
Biological products, including active pharmaceutical ingredients (APIs), are the focus of the document, which by implementing manufacturers should align their process validation activities with the product lifecycle concept and existing FDA guidance.
The document 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.”
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.
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.
Documentation and analytical methodology are also covered in the guidance, which can be found here.
