Saturday, March 12, 2011

Types of Process Validation

– 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
– 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)

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

– 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

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