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What Is Validation Protocol? |
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Answer» A written plan of ACTIONS stating how process validation will be conducted; it will specify who will conduct the various tasks and define testing parameters; SAMPLING plans, testing methods and SPECIFICATIONS; will specify product CHARACTERISTICS, and equipment to be used. It must specify the minimum number of batches to be used for validation studies; it must specify the acceptance criteria and who will sign/approve! Disapprove the CONCLUSIONS derived from such a scientific study. A written plan of actions stating how process validation will be conducted; it will specify who will conduct the various tasks and define testing parameters; sampling plans, testing methods and specifications; will specify product characteristics, and equipment to be used. It must specify the minimum number of batches to be used for validation studies; it must specify the acceptance criteria and who will sign/approve! Disapprove the conclusions derived from such a scientific study. |
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