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Re-validation is usually done to confirm the initial validity for a periodic review. Revalidation provides evidence that changes in a process and/or introduced process environment do not adversely affect process characteristics and product quality. The documentation requirements will be the same as for the initial validation process.
In some situations re-validation becomes necessary. The following are some examples of planned or unplanned changes that may require revalidation:
• Changes in raw materials (physical properties such as density, viscosity, particle size distribution, and moisture content, etc., which may affect the process or product).
• Change in source of active raw material manufacturer.
• Change in packaging material (primary container/closed system).
• Changes in process (eg, mixing time, drying temperature and batch size)
• Equipment modifications (eg addition of automatic detection systems). Equipment changes involving replacement of equipment on a “like for like” basis do not generally require revalidation but this new equipment must be qualified.
• Plant/facility changes.
• Variation revealed by trend analysis (eg process flow).
The decision not to conduct a revalidation study must be fully justified and documented.
