Purpose: This document outlines the procedure for revalidating equipment, processes, and systems to ensure continued compliance with established standards and regulatory requirements.

1. Revalidation Categories

1.1. Process Revalidation: Generally, process revalidation (excluding sterile/aseptic processes) is not routinely performed. Validated status is maintained through the change control system. Revalidation outside of change control is considered only if there are repeated or unexplained batch failures or unfavorable analytical trends.

1.2. Cleaning Revalidation: Revalidation of cleaning procedures is not necessary unless there is evidence of inadequate cleaning effectiveness or significant changes to manufacturing equipment or processes.

1.3. Analytical Methods Revalidation: Routine revalidation of analytical methods is not required. Revalidation is typically initiated by recurring analytical problems or excessive out-of-specification results related to the method. Revalidation of pharmacopeial methods is not required, however, verification is necessary when these methods are updated.

1.4. Equipment and Systems Re-qualification: Equipment and systems that have not undergone major changes or experienced repeated unexplained failures are considered to remain in a qualified state and do not require revalidation.

2. Initiation

2.1. The Validation Committee is responsible for developing and maintaining an overall revalidation plan. This plan is based on the initial validation of the equipment, process, or system.

2.2. The criticality of the equipment, process, or system, along with its inherent tendency to change, are key factors in establishing the revalidation program. Revalidation requirements are documented in the initial validation report and can be adjusted over time as more information becomes available.

2.3. cGMP mandates annual revalidation of all critical processes and whenever significant changes are made to equipment, processes, or systems. These revalidation activities are typically preceded by a major preventative maintenance and calibration program conducted by the Maintenance Department.

3. Changes Triggering Revalidation: (This needs to be fully defined based on the organization’s specific requirements. Examples include changes in equipment, process, materials, environment, or software.)

4. Maintenance Department Responsibilities: The Maintenance Department performs major preventative maintenance and calibration and completes the Equipment Checklist. They then notify the Validation Department before handing over the equipment for revalidation testing.

5. Validation Department Responsibilities: The Validation Department is responsible for creating revalidation protocols, conducting qualification tests, managing any discrepancies, preparing the revalidation file, and granting conditional release.

6. Revalidation Protocols: Revalidation protocols define the test objective, acceptance criteria, test method, and document the results obtained.

7. Revalidation Scheduling: The revalidation schedule is developed considering current production activities and the availability of the equipment, process, or system. Studies should ideally be performed within one month of the anniversary of the previous revalidation (i.e., between 11 and 13 months). Any extension beyond this timeframe requires documented approval from the Quality Assurance Manager. Without this approval, the equipment, process, or system cannot be used for production.

8. Equipment Checklist: The Equipment Checklist ensures that all parameters are correctly configured after any maintenance or adjustments, verifying that the equipment, process, or system remains within its original validated parameters. These checklists are developed by the Project Team during the Operation & Performance Qualification of new equipment, processes, or systems. The checklists are stored and maintained by the Validation Department and provided to the Maintenance team prior to revalidation activities. The Maintenance Department is responsible for approving the Equipment Checklists.

9. Revalidation Discrepancy Forms: Any issue, such as not meeting acceptance criteria, requires a Validation Discrepancy Form (Form-370). This form details the discrepancy, the corrective actions taken, and includes a sign-off confirming that the actions were completed and effective. If a production batch is involved in revalidation activities and acceptance criteria are not met, a Deviation Report (SOP QMS-035) is also generated, and a copy is attached to the Discrepancy Form.

10. Release of Revalidated Equipment: Upon successful completion of all physical testing, the Validation staff who performed the revalidation may grant conditional release to the Production Manager. A Deviation Report is also initiated to prevent any product release until the Revalidation protocol has been formally signed off.

11. Preparation of the Revalidation File: The Revalidation file provides documented evidence that the equipment, process, or system is performing as intended. It includes a summary of all changes and performance checks conducted since the last revalidation. The Validation staff compiles the file, and the validation manager reviews it within eight working days of the completion of maintenance, calibration, checklist verification, and testing. The file is then circulated to the Validation Committee for review and approval.

11.1. Summary of Activities: The validation staff prepares a summary of all relevant Change Control System forms and an overview of the Revalidation Programme.

11.2. Revalidation Report – Final Review & Approval Document: ( It should describe the specific content of the final report, including a summary of test results, analysis of the data, conclusions regarding the revalidation, and documentation of all approvals.)