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For process characterization was a CE matrix or DOE used to identify key operational characteristics?
Process parameter limits determined from process characterization studies
Are all controlled variables/parameters verified and checked for operation at the extremes of the operational range?
Product/coupon/process **provide worst case challenge rational**, including handling, ID, traceability and disposition
Performance Qualification (PQ) establishes by objective evidence that the process, under anticipated conditions, is stable, capable, and consistently produces a product which meets all predetermined requirements and does not adversely affect the finished product.
The following PQ elements are evaluated and documented in the validation protocol:
EIQ's, EOQ's, SIQ's and SOQ's are completed before POQ execution
Does POQ provide acceptance criteria for process capability
Does POQ testing provide expected and actual results
Product, process parameters, and procedures established in the