Follow
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 person of the concerned department and approved before implementation.
VALIDATION PROTOCOL DOCUMENT This document will help in developing a new validation protocol for validation activities in various departments of pharmaceutical companies. A validation protocol should include (but not be limited to) the following parts.
1. Protocol Approval: The protocol should be reviewed by the head of the concerned department and approved by the head of quality assurance.
2. Objective: The objective of the validation study should be written with the objective of the validation protocol.
3. Scope: The area of validation to which the protocol will apply. Protocols are associated with specific categories and areas.
4. Reasons for Validation: Reasons behind validation due to which the process or method is being validated. If the product or method is new, write “New Product” or “New Method”.
5. Criteria for Re-examination: The circumstances under which we will re-examine the process should be mentioned.
6. Responsibilities: Responsibilities of each department involved in validation activities should be defined.
7. Reference Documents: The documents used to complete the validation activities should refer to specifications, standard operating procedures, BMR, BPR, methods of analysis, other protocols etc.
8. Procedure: How the validation process will be conducted during the process, should be written. It should contain equipment operating procedure, sampling method, sampling time, sample quantity, analysis method, calculation etc.
9. Deviations: All deviations from the written procedure should be recorded during the entire validation activity. Any deviation should be stopped before completion of validation process.
10. Conclusion: The validation activity should be concluded. The overall result of the validation should be written in the conclusion if the validation passed or failed.
11. Reports: Reports with raw data should be attached as Annexure. The data should be compiled by the competent person of the concerned department and checked by the reviewer.
12. Report Approval: Reports should be reviewed by concerned department and approved by Head of Quality Assurance. Report approval shows that the verification was completed successfully and according to the validation protocol.
