Process Validation (PV), according to the FDA, is collecting and assessing data right from the design stage till the production stage. PV is set out for all the stages of production for a product in the FDA-regulated industries. The core purpose of PV is to establish scientific proof that any process being employed has the capability of delivering quality products consistently.
The FDA’s process validation requirements are set out in its general principles of Process Validation. Starting from 1987, the FDA has been issuing guidelines at intervals to state, improve and strengthen the general principles of Process Validation. In almost a quarter century of the first guideline, the revision of January 2011 came into being. This guideline is considered a landmark and a guide for PV professionals since it reworked extensively and expanded the general principles on process validation. It is the current guideline from the FDA on Process Validation requirements.
These are what the FDA’s 2011 guideline on general principles on Process Validation propagate:
Process validation is tied to the product lifecycle approach by the FDA general principles on process validation of 2011. The central purpose of process validation is to ensure that the process is in a state of control at all stages of production.
The following points illustrate the reason for which the FDA expects its PV requirements to be met:
The FDA stipulates three layers or stages on which its general principles of Process Validation are built: