Process Validation in Drug Development

Process validation is simply ensuring that the particular process is capable of routinely producing finished material that meets all finished material specifications. Validation can be applied to any type of process and is applicable to the manufacture of both APIs and finished products. It is typically one of the final steps prior to commercialization. Introduction of Quality by Design (QbD) probably means there will be changes to our thinking and understanding of validation. The traditional concept of a three-batch validation will be replaced with a 'design space' and something akin to continuous validation.

FinnBrit Consulting can provide advice on all aspects of medicinal product process validation.

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