Follow
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 runs and acceptance test results.
Contents:
– Protocol Approval
– Table of contents
– Objective
– Scope
– Responsibility
– Accountability
– Validation team
– Brief manufacturing process (Description, Flow chart, Reaction scheme)
– Selection of batches
– List of equipments used in the manufacturing process
– List of raw materials used in the manufacturing process
– Critical operations with justification
– In-process controls with acceptance criteria
– Sampling & testing plan with frequency
– Stability programm
– Data to be complied
– Acceptance criteria
– Intermediate & final products quality & yield
– Stability specification
– Document review
– Conclusion
– Revalidation criteria
