Follow
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 be measured, the allowable range of variability and how the method will be tested.
The validation protocol provides a summary of what is expected. The protocol should list the selected process and control parameters, specify the number of batches that will be included in the study, and specify how the data, once collected, will be treated for relevance. The date of approval by the validation team should also be mentioned.
In cases where a protocol is modified or changed after its approval, appropriate justification for such changes must be documented.
The validation protocol should be numbered, signed and dated and should contain at least the following information:
• Objectives, scope of coverage of the validation study.
• Validation team membership, their qualifications and responsibilities.
• Type of validation: prospective, concurrent, retrospective, re-validation.
• Number and selection of batches to be on the validation study.
• A list of all equipment to be used; their normal and worst case operating parameters.
• Outcome of IQ, OQ for critical equipment.
• Requirements for calibration of all measuring devices.
• Critical process parameters and their respective tolerances.
• Description of the processing steps: copy of the master documents for the product.
• Sampling points, stages of sampling, methods of sampling, sampling plans.
• Statistical tools to be used in the analysis of data.
• Training requirements for the processing operators.
• Validated test methods to be used in in-process testing and for the finished product.
• Specifications for raw and packaging materials and test methods.
• Forms and charts to be used for documenting results.
• Format for presentation of results, documenting conclusions and for approval of study results.
