Responsible for overseeing the revalidation process, ensuring that it is conducted properly, and ensuring that all documentation is accurate and complete.

4. Accountability

The QC Manager is accountable for ensuring that analytical methods are revalidated as per the procedure and that the results are documented and approved. The QA Manager is responsible for reviewing and ensuring that revalidation meets the regulatory requirements. The Laboratory Supervisor ensures the proper execution and documentation of revalidation activities.

5. Procedure

5.1 Initiating the Revalidation Process

1. Revalidation of an analytical method is required when there is a change in the following:
   • Test method or test procedure
   • Testing equipment or apparatus
   • Raw material or ingredient specifications
   • Significant changes in production conditions
   • Out-of-specification (OOS) results from previous tests that require investigation
2. Review the previous method validation report to assess the baseline conditions and determine if revalidation is necessary based on changes or concerns.
3. Ensure that all necessary resources, such as reagents, equipment, and materials, are available for revalidation.
4. Notify the QA team of the intent to perform revalidation and establish a timeline for the process.

5.2 Revalidation Procedure

1. Perform the revalidation by following the original test procedure, and ensure that the same sample types are tested under the same conditions (if possible) to compare the results.
2. Verify that all parameters in the method validation report are evaluated, including precision, accuracy, linearity, range, specificity, robustness, and sensitivity.
3. Conduct tests on multiple sample batches to verify consistency in results. Record any variations and assess if they are within the acceptable range.
4. Ensure that all equipment used in the testing is calibrated and functioning properly. Any equipment found to be out of specification must be calibrated or replaced before continuing with the revalidation.

5.3 Data Analysis and Interpretation

1. Analyze the data obtained during revalidation and compare it to the previous validation results and the product specifications.
2. If the results are within acceptable limits and no significant discrepancies are found, confirm the method’s continued suitability for use.
3. If discrepancies are found or if the results fall outside of the acceptable range, determine the cause of the deviation and conduct additional testing or corrective actions as needed.
4. Document all findings, including any corrective actions taken, in the Revalidation Report (Annexure-1).

5.4 Review and Approval

1. The QC Manager must review the revalidation results and ensure that the analytical method is suitable for its intended use, based on the revalidation results.
2. Submit the Revalidation Report (Annexure-1) to the QA team for review and approval.
3. Once approved, update any relevant SOPs, testing methods, and batch records to reflect the validated method.
4. If the revalidation is unsuccessful, initiate corrective actions and determine if a new method or approach is required.

5.5 Documentation and Record-Keeping

1. Ensure that all revalidation activities, including data, findings, and corrective actions, are thoroughly documented in the Revalidation Report (Annexure-1).
2. All records related to revalidation must be securely stored and easily accessible for audits and inspections. Retain records for a minimum of two years or as required by regulatory guidelines.
3. Ensure that all relevant documentation is reviewed and approved by the QA team to ensure compliance with GMP and regulatory standards.

6. Abbreviations

• GMP: Good Manufacturing Practices
• QC: Quality Control
• QA: Quality Assurance
• PPE: Personal Protective Equipment
• OOS: Out-of-Specification

7. Documents

1. Annexure-1: Revalidation Report

8. References

• Good Manufacturing Practices (GMP) Guidelines – 21 CFR Part 211
• International Conference on Harmonisation (ICH) Q7 – Good Manufacturing Practice for Active Pharmaceutical Ingredients
• Pharmacopeial Monographs on Analytical Method Validation

9. SOP Version

Version: 2.0

10. Approval Section

	Prepared By	Checked By	Approved By
Signature
Date
Name
Designation
Department

11. Annexures

Annexure-1: Revalidation Report

Batch Number	Method Name	Revalidation Date	Result	Corrective Actions	Approved By
12345	Viscosity	21/01/2026	Pass	None	QA Head

Revision History:

Revision Date	Revision No.	Revision Details	Reason for Revision	Approved By
01/03/2024	1.0	Initial Version	New SOP Creation	QA Head
01/03/2025	2.0	Format Revision and Updates	Standardization of Document	QA Head