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PQ – Process Performance Qualification

Documentation indicating that the process is reproducible, stable, and efficient for all required operating circumstances. This should incorporate items such as operating condition under maximum predictable situations and worst-case predictable process parameters. This should be done after the process design phase.

Experimentation should require a minimum of three batches or lots with a predetermined and acceptable sample size that can be guaranteed to be statistically valid.

Also see Process, Process improvement, Process management, Appraisal cost, and Process map (flowchart).

 

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Last Updated: Saturday, 10-Jun-06 15:50:57 PDT

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