What is validation, validation protocol and validation master plan?
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Validation: Action of proving and documenting that any process, procedure or method actually leads to expected results.
The validation protocol is a writing plan stating how validation will be conducted, including test parameters, product characteristics, product equipment and decision point on what constitutes acceptable test results.
Validation master plan is a high level document that establishes am umbrella validation plans for the entire project and summarizes the manufacturer's overall philosophy and approach, to be used for establishing performance adequacy. It provides information on the manufacturer's validation work programme and defines details of and time-scales for the validation work to be perform, including stating the responsibilities relating to the plan.
The validation protocol is a writing plan stating how validation will be conducted, including test parameters, product characteristics, product equipment and decision point on what constitutes acceptable test results.
Validation master plan is a high level document that establishes am umbrella validation plans for the entire project and summarizes the manufacturer's overall philosophy and approach, to be used for establishing performance adequacy. It provides information on the manufacturer's validation work programme and defines details of and time-scales for the validation work to be perform, including stating the responsibilities relating to the plan.
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