A written plan stating, how validation will be conducted and defining acceptance criteria e.g: The protocol for manufacturing process identifies process equipments, critical process parameters, and / or operating range, product characteristics, sampling, test data to be collected, number of validations ...

A protocol is a written statement to govern the validation process, including methods, test procedures, equipment handling, specifications, acceptance criteria, reporting, and approvals. Validation protocols must be written before carrying out a validation activity. It should be prepared by the competent ...

Proper execution of protocol is an important part of the validation process. Execution of validation protocol affects the validation results. There should be minimum deviations during the validation process. Following tips will help in a smooth execution of a validation protocol: 1. Specifications and ...

A written plan specifying how validation will be conducted, including test parameters, product characteristics, manufacturing and packaging equipment, and decision points for what constitutes acceptable test results. This document should detail the critical steps in the manufacturing process that should ...