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Introduction to Performance and Process Qualification (P1Q & P2Q). The purpose of performance and process qualification is to provide documented evidence that the rigorous inspection testing carried out during the qualification of this process, demonstrates the effectiveness and reproducibility of the process. In entering the performance qualification phase of validation, it is understood that the process specifications have been established and essentially proven acceptable through laboratory or other trial methods and that the equipment has been judged acceptable on the basis of suitable validations installation and operational studies.
Each process must be defined and described with sufficient specificity to enable operators to understand what is required. It is also very important that challenge conditions simulate those that will be encountered during actual production, including "worst case" conditions. The challenges should be repeated enough times to assure that the results are meaningful and consistent. |