PQ (Performance Qualification)

The PQ demonstrates that equipment, in its real environment, with its final product and trained personnel, produces reproducibly and in accordance with defined quality attributes. We typically execute it over three consecutive batches (or a statistically justified number), varying parameters within the design space boundaries (Design Space ICH Q8). Statistical analyses produced include Cpk, process capability and trend analyses, reviewed by quality. PQ batches can be commercialized if compliant, which rapidly pays back the phase. Once the PQ is approved and the validation report signed, the equipment enters routine operation under Continuous Process Verification (ICH Q8), with continuous monitoring of critical parameters.