Validation protocol and report

A suggested scheme for the validation protocol and subsequent report concerning a particular process is shown below:

Part 1. Purpose (the validation) and prerequisites
Part 2. Presentation of the entire process and subprocesses, flow diagram, critical steps/risks
Part 3. Validation protocol, approval
Part 4. Installation qualification, drawings
Part 5. Qualification protocol/report

5.1 Subprocess 1

5.1.1 Purpose

5.1.2 Methods/procedures, list of manufacturing methods, SOPs, and written procedures, as applicable

5.1.3 Sampling and testing procedures, acceptance criteria (detailed description of, or reference to, established procedures, as described in pharmacopoeias)

5.1.4 Reporting

5.1.4.1 Calibration of test equipment used in the production process

5.1.4.2 Test data (raw data)

5.1.4.3 Results (summary)

5.1.5 Approval and requalification procedure

5.2 Subprocess 2 (same as for Subprocess 1)

5.n Subprocess n

Part 6. Product characteristics, test data from validation batches

Part 7. Evaluation, including comparison with the acceptance criteria and recommendations (including frequency of revalidation/requalification)

Part 8. Certification (approval)

Part 9. If applicable, preparation of an abbreviated version of the validation report for external use, for example by the regulatory authority

The validation protocol and report may also include copies of the product stability report or a summary of it, validation documentation on cleaning, and analytical methods.