Types of Process Validation

Prospective
– Validation conducted prior to the distribution of either a new product, or product made under a revised manufacturing process, where the revisions may affect the product's characteristics.

There are three phases of prospective
validation:
– Installation qualification (Process equipment consistently operates within established limits and tolerances)
– Process performance qualification (The process is effective and reproducible)
– Product performance qualification (The finished product produced by a specified process meets all release requirements for functionality and safety)

Concurrent
– A subset of prospective validation conducted with the intention of ultimately distributing product manufactured during the validation study

Retrospective
– Validation of a process for a product already in distribution based upon accumulated production, testing and control data


In this validation there is an assumption, typically unmet, of complete records
– Customer complaints not investigated
– Investigations without adequate corrective action
– Scrap and rework not fully documented
– Inadequate process variability records