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- W2461570602 abstract "Stage III, Continued Process Verification (CPV) is the last part of the process validation life cycle. In completing this stage of the work, each process run needs to be evaluated for compliance and consistency both within and between batches. In order to do this effectively, a statistical process control program should written and implemented. Control charts should be used for each Critical Process Parameter/Critical Quality Attribute (CPP/CQA) and trends (if any) established and investigated. This stage is also used in evaluating legacy products compliance to the new process validation guideline. Data collected in this stage of the program can be used to support the annual product review report. A statistician should be consulted in developing this part of the program so that the evaluations will be made with proper statistical modeling." @default.
- W2461570602 created "2016-07-22" @default.
- W2461570602 creator A5029002969 @default.
- W2461570602 date "2016-01-01" @default.
- W2461570602 modified "2023-09-25" @default.
- W2461570602 title "Stage III—Collection and Evaluating Production Data" @default.
- W2461570602 doi "https://doi.org/10.1016/b978-0-12-804148-2.00010-x" @default.
- W2461570602 hasPublicationYear "2016" @default.
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