VAL 010 Revalidation Procedure Sample

Standard Operating Procedure
Title: Revalidation Procedure

______________________________________________________________________________________
3. Changes that warrant Revalidation include 2
4. Basic Steps during Revalidation 3
5. Revalidation Activities and Specific Responsibilities 3
6. Revalidation Protocols 4
7. Revalidation Timing 4
8. Equipment Checklist 4
9. Revalidation Discrepancy Forms 4
10. Release of Revalidated Equipment 4
11. Preparation of the Revalidation File 4
12. Flow Chart - Revalidation Activities 6
13. Summary of Changes 6
Procedure
1. Revalidation Categories
1.1. Process Revalidation
With the exception of sterile/aseptic processes, process revalidation is NOT frequent as
validated status is maintained via a change control process. The need for any revalidation
outside of the change control process will be considered in response to repeated or
unexplained batch failures or any adverse analytical trends.
1.2. Cleaning Revalidation
There is NO need to revalidate the process unless it is clear that the effectiveness of the
cleaning procedures is inadequate or where significant changes in the manufacturing
equipment or process have occurred.
1.3. Analytical Methods Revalidation
The routine revalidation of analytical methods is NOT necessary. Revalidation will therefore
normally result from the recurrence of analytical problems or excessive out of specification
results associated with the analytical method.
1.4. Revalidation of Pharmacopeial methods is NOT necessary, but need to verify when such
methods are updated
1.5. Equipment and Systems Re-qualification

If the Equipment/system has NOT been to subject to any major change or repeated
unexplained failures the Equipment/system is considered to remain qualified and NO need
for revalidation.
2. Initiation
2.1. It is the responsibility of the Validation Committee to provide an overall plan describing and
defining the subject for revalidation based on the initial Validation of the
equipment/process/system. The criticality of the equipment/process/system, plus a
knowledge of its inherent tendency to change, are considered when establishing the
equipment/process/system revalidation programme. The revalidation requirements are
documented as part of the Validation report at the time of initial validation but may be
modified over time when further knowledge of the equipment/process/system is gained.
2.2. Revalidation is required by the cGMP to be carried out on annual basis on all critical
processes or when significant changes have been made to the equipment/process/system.
Revalidation activities are usually preceded by a major preventative maintenance/calibration
programme conducted by the Maintenance Department.
3. Changes that warrant Revalidation include
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Standard Operating Procedure
Title: Revalidation Procedure
______________________________________________________________________________________
the team member of the Maintenance department prior to the hand over to the Validation
Department to conduct the actual revalidation qualification tests.
6. Revalidation Protocols
Revalidation Protocols are used to highlight the Test Objective, Acceptance Criteria, Test Method,
and the results obtained.
7. Revalidation Timing
Revalidation schedule should be prepared taking into account the current production activities, which
will determine the availability of the equipment/process/system. Therefore, studies are to be
conducted in the time frame of plus or minus one month of the most recent past revalidation, (i.e.
11-13months). If an extension beyond that date occurs without revalidation being conducted, the
equipment/process/system cannot be used for production activities without the specific
documented approval of the Quality Assurance Manager.
8. Equipment Checklist
An Equipment Checklist is used to ensure that all parameters are set correctly after any
maintenance/adjustments have been made. The principle is to ensure that the
equipment/process/system has not altered from the original, validated parameters. Checklists are
developed during the Operation & Performance Qualification by the Project Team for new
equipment/processes/systems.
The checklist is stored with the Validation Department to ensure that current versions are maintained
and issued by the validation staff to the Maintenance team prior to the revalidation activities.
The Equipment Checklists are approved by the Maintenance Department.
9. Revalidation Discrepancy Forms

Where a problem occurs, such as acceptance criteria not being met, a Validation Discrepancy Form
(Form-370) must be filled out detailing the discrepancy the action that has been taken to address the
discrepancy and a sign off to indicate that the actions have been satisfactorily completed and are
effective in addressing the problem. For production batches used under revalidation activities a
Deviation Report (SOP QMS-035) is raised if the acceptance criteria was not met and a copy of DR
is attached to the Discrepancy form.
10. Release of Revalidated Equipment

If all physical testing is successful at the completion of the revalidation program, conditional release
may be granted to the Production Manager via Validation staff carried out the revalidation. At the
same time, a DR is to be raised to ensure that no product is released to the market until the
Revalidation protocol is signed off.
11. Preparation of the Revalidation File

The Revalidation file provides the documented evidence that the equipment, process or systems are
performing to their predetermined use as stated in each test function. In addition, a summary of all
the changes and performance checks carried out since the last revalidation campaign is included.
The file is compiled by Validation staff and checked by validation manager within 8 working days of
the maintenance, calibration, checklist and test functions being completed then it is circulated to
members of the Validation Committee for review and approval.
Revalidation file comprises of the following sections:
11.1. Summary of Activities
A summary list of all the registered forms from the Change to Control System and an outline
of the Revalidation Programme are prepared by the validation staff.
11.2. Revalidation Report - Final Review & Approval document:
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Standard Operating Procedure

Title: Revalidation Procedure

1.5. Equipment and Systems Re-qualification

3. Changes that warrant Revalidation include

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9. Revalidation Discrepancy Forms

10. Release of Revalidated Equipment

11. Preparation of the Revalidation File

11.2. Revalidation Report - Final Review & Approval document:

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