Procedure for Requalification of Key Equipment
| Department | Quality Assurance (QA)/Validation/Engineering/Production |
|---|---|
| SOP No. | SOP/Ointment/135 |
| Supersedes | V 1.0 |
| Page No. | Page X of Y |
| Issue Date | [Insert Issue Date] |
| Effective Date | [Insert Effective Date] |
| Review Date | [Insert Review Date] |
1. Purpose
The purpose of this Standard Operating Procedure (SOP) is to define the process for requalification of key equipment in ointment manufacturing. Requalification ensures that critical equipment continues to perform within established specifications and regulatory requirements over time.
2. Scope
This SOP applies to all personnel in the Quality Assurance (QA), Validation, Engineering, and Production departments responsible for requalification of key equipment such as mixing tanks, filling machines, and packaging lines.
3. Responsibilities
- QA Officer: Ensures compliance with requalification protocols.
- Validation Team: Develops and executes requalification protocols.
- Engineering Team: Supports maintenance, calibration, and verification of equipment.
- Production Supervisor: Ensures adherence to requalification testing procedures.
- QA Manager: Approves requalification reports and maintains documentation.
4. Accountability
The QA and Validation Managers are accountable for ensuring that key equipment is requalified as per GMP, FDA, ICH, and WHO guidelines.
5. Procedure
5.1 Identification of Equipment for Requalification
- Prepare a list of key equipment that requires periodic requalification.
- Identify critical parameters affecting equipment performance.
- Define requalification frequency based on:
- Regulatory requirements
- Manufacturing workload
- Previous qualification results
- Historical performance data
5.2 Requalification Criteria
- Requalification should be conducted:
- At predefined intervals (e.g., annually or biennially).
- After major maintenance or
equipment modifications.
Following deviations or out-of-specification (OOS) results.
Define acceptance criteria for each piece of equipment.
5.3 Execution of Requalification
5.3.1 Installation Verification
- Confirm that equipment is securely installed and aligned properly.
- Verify utility connections (electrical, pneumatic, and hydraulic).
5.3.2 Operational Qualification (OQ) Testing
- Verify that control panels, alarms, and sensors function correctly.
- Ensure the equipment operates within defined parameters:
- Temperature stability
- Agitation/mixing speeds
- Filling accuracy
- Vacuum and pressure stability
- Conduct multiple test runs and record results.
5.3.3 Performance Qualification (PQ) Testing
- Process test batches using actual manufacturing conditions.
- Measure equipment performance against acceptance criteria.
- Ensure product consistency, uniformity, and reproducibility.
- Document any deviations and take corrective actions.
5.4 Handling Deviations
- If equipment fails requalification:
- Investigate root cause of failure.
- Initiate corrective and preventive actions (CAPA).
- Retest equipment after corrective measures.
- All deviations must be documented and reviewed by QA.
5.5 Documentation and Approval
- Record all requalification data in the Equipment Requalification Log.
- QA must review and approve requalification results before production resumes.
- Maintain all records for regulatory audits.
6. Abbreviations
- GMP – Good Manufacturing Practices
- QA – Quality Assurance
- PQ – Performance Qualification
- OQ – Operational Qualification
- IQ – Installation Qualification
- CAPA – Corrective and Preventive Actions
7. Documents
- Equipment Requalification Protocol (Annexure-1)
- Equipment Requalification Log (Annexure-2)
8. References
- ICH Q7 – Good Manufacturing Practice Guide
- WHO Guidelines for Equipment Qualification
- US FDA Guidance on Equipment Requalification
9. SOP Version
Version 2.0
10. Approval Section
| Prepared By | Checked By | Approved By | |
|---|---|---|---|
| Signature | |||
| Date | |||
| Name | |||
| Designation | |||
| Department |
11. Annexures
Annexure-1: Equipment Requalification Protocol
| Equipment Type | Test Parameter | Acceptance Criteria |
|---|---|---|
| Mixing Tank | Agitation Speed | ± 5% of set value |
| Filling Machine | Fill Volume Accuracy | ± 1% of target |
Annexure-2: Equipment Requalification Log
| Date | Equipment ID | Test Performed | Result | Reviewed By |
|---|---|---|---|---|
| 01/02/2025 | MIX-1001 | Agitation Speed Test | Pass | QA Manager |
| 02/02/2025 | FILL-1002 | Filling Volume Test | Pass | QA Manager |
12. Revision History:
| Revision Date | Revision No. | Details of Revision | Reason for Revision | Approved By |
|---|---|---|---|---|
| 01/01/2024 | 1.0 | Initial Version | New SOP | QA Head |
| 01/02/2025 | 2.0 | Updated SOP Format | Standardization of Document | QA Head |