Procedure for Operational Qualification (OQ) of Mixing Tanks
| Department | Quality Assurance (QA)/Validation/Engineering/Production |
|---|---|
| SOP No. | SOP/Ointment/133 |
| 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 conducting Operational Qualification (OQ) of mixing tanks in ointment manufacturing. This ensures that the mixing tanks operate consistently and reliably within specified parameters under normal operating conditions.
2. Scope
This SOP applies to all personnel in the Quality Assurance (QA), Validation, Engineering, and Production departments responsible for performing and documenting Operational Qualification (OQ) for mixing tanks.
3. Responsibilities
- QA Officer: Ensures compliance with OQ protocols.
- Validation Team: Develops and executes OQ protocols.
- Engineering Team: Supports testing and calibration of mixing tanks.
- Production Supervisor: Ensures adherence to qualification testing procedures.
- QA Manager: Approves OQ reports and ensures documentation accuracy.
4. Accountability
The QA and Validation Managers are accountable for ensuring that Operational Qualification (OQ) is conducted as per GMP, FDA, ICH, and WHO guidelines.
5. Procedure
5.1 Preparation for Operational Qualification (OQ)
- Ensure that Installation Qualification (IQ) has been successfully completed.
- Review and approve the Operational Qualification Protocol.
- Verify the availability of calibrated test instruments.
- Assign trained personnel to conduct the OQ tests.
5.2 Execution of Operational Qualification (OQ)
5.2.1
Functional Testing
- Power on the mixing tank and ensure proper startup sequence.
- Verify the functionality of control panels, alarms, and safety features.
- Ensure emergency shutdown mechanisms work as expected.
5.2.2 Performance Testing
- Run the mixing tank under normal operating conditions.
- Test and verify:
- Agitation speed and RPM control
- Temperature regulation within specified limits
- Homogeneity of test batches
- Heating and cooling efficiency
- Document all performance parameters.
5.2.3 Repeatability and Consistency Testing
- Conduct repeated test cycles to confirm consistent performance.
- Ensure all test results meet predefined acceptance criteria.
- Identify any operational deviations and document corrective actions.
5.3 Documentation and Approval
- Record all OQ data in the Operational Qualification Log.
- QA must review and approve OQ results before proceeding to Performance Qualification (PQ).
- Maintain all records for regulatory audits.
6. Abbreviations
- GMP – Good Manufacturing Practices
- QA – Quality Assurance
- OQ – Operational Qualification
- IQ – Installation Qualification
- PQ – Performance Qualification
7. Documents
- Operational Qualification Protocol (Annexure-1)
- Operational Qualification Log (Annexure-2)
8. References
- ICH Q7 – Good Manufacturing Practice Guide
- WHO Guidelines for Equipment Qualification
- US FDA Guidance on Operational Qualification
9. SOP Version
Version 2.0
10. Approval Section
| Prepared By | Checked By | Approved By | |
|---|---|---|---|
| Signature | |||
| Date | |||
| Name | |||
| Designation | |||
| Department |
11. Annexures
Annexure-1: Operational Qualification Protocol
| Equipment Type | Test Parameter | Acceptance Criteria |
|---|---|---|
| Mixing Tank | Agitation Speed | ± 5% of set value |
| Mixing Tank | Temperature Control | ± 2°C of setpoint |
Annexure-2: Operational Qualification Log
| Date | Equipment ID | Test Performed | Result | Reviewed By |
|---|---|---|---|---|
| 01/02/2025 | MIX-1001 | Agitation Speed Test | Pass | QA Manager |
| 02/02/2025 | MIX-1002 | Temperature Control 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 |