What are the contents of a process validation protocol and report?

Question

Accepted Answer

The contents of a process validation protocol and report include detailed information about the validation process and its results.

Purpose and scope of the validation
Description of the process being validated
Validation criteria and acceptance criteria
Methods and procedures used for validation
Sampling plan and sample size
Data collection and analysis
Results and conclusions
Recommendations for process improvements
Signatures and approvals

Accepted Answer

Introduction of product, raw material used, Equipment qualification details, Masters list of documents, batches selection, process and quality details, results, recommendations, summary & conclusion

Asked in R L Fine Chem

What are the contents of a process validation protocol and report?

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