Learn how to write (IQ, OQ & PQ) qualifications of injectable tanks to ensure compliance, performance, and safety in pharmaceutical manufacturing processes.
1. PURPOSE
To describes the procedure for the qualification of injectable manufacturing tanks to ensure compliance with regulatory standards and operational requirements.
2. SCOPE
This SOP is applicable to all injectable manufacturing tanks used for the production of sterile injectable products within the facility.
3. RESPONSIBILITIES
3.1 Engineering Department is responsible to perform qualification activities and maintain records.
3.2 Production Department is responsible to provide support during qualification.
3.3 Quality Assurance (QA) department is responsible to review and approve qualification protocols and reports.
4. ACCOUNTABILITY
Head of the Quality Assurance Department
5. ASSOCIATED DOCUMENTS / REFERENCES
5.1 Validation Master Plan (VMP).
6. PRECAUTIONS
N/A
7. PROCEDURE
7.1 Materials and Equipment
7.1.1 Calibration instruments (temperature sensors, pressure gauges, etc.).
7.1.2 Cleaning agents.
7.1.3 Validation tools (e.g., data loggers, sampling devices).
7.2 Design Qualification (DQ)
7.2.1 Review the tank’s technical drawings, capacity, and compliance with cGMP requirements.
7.2.2 Ensure compatibility with the intended product and process.
7.2.3 Document the findings in the Design Qualification Report.
7.3 Installation Qualification (IQ)
7.3.1 Verify the tank is installed as per the manufacturer’s recommendations and approved layout.
7.3.2 Check that all components, such as agitators, valves, and sensors, are installed correctly and securely.
7.3.3 Ensure all connections (electrical, hydraulic, and pneumatic) are properly made and labeled.
7.3.4 Confirm the tank is free of damage, corrosion, or contamination.
7.3.5 Verify calibration of critical instruments like pressure gauges and temperature sensors.
7.3.6 Prepare and document an Installation Qualification Report.
7.4 Operational Qualification (OQ)
7.4.1 Test the tank’s functionality under operational conditions without product (dry run).
Verify critical parameters, including:
– Agitator speed and uniformity.
– Heating and cooling system performance.
– Pressure and vacuum capabilities.
– Integrity of gaskets, seals, and valves.
– Conduct alarm and interlock testing for safety systems.
– Perform system integrity checks, such as leak tests.
– Document all results in the Operational Qualification Report.
7.5 Performance Qualification (PQ)
7.5.1 Test the tank under actual operating conditions with a placebo or simulated product.
7.5.2 Evaluate critical parameters over three consecutive batches, including:
7.5.3 Mixing efficiency and homogeneity of the product.
7.5.4 Sterility assurance (conduct microbial sampling).
7.5.5 Heating and cooling cycles’ reproducibility.
7.5.6 Validate cleaning procedures to ensure no residual contamination.
7.5.7 Document the Performance Qualification results in the PQ Report.
7.6 Requalification
7.6.1 Perform requalification periodically as per the requalification schedule or after major maintenance/repairs.
7.6.2 Requalification may involve IQ, OQ, or PQ based on the extent of changes.
7.7 Acceptance Criteria
7.7.1 The tank must meet the specifications and performance criteria established in the qualification protocol.
7.7.2 All deviations must be documented and resolved before final approval.
7.8 Documentation and Approval
7.8.1 Maintain the following documents:
– Qualification protocol and reports (DQ, IQ, OQ, PQ).
– Calibration certificates.
– Deviation reports and corrective actions.
7.8.2 Submit the qualification report to Head of Quality Assurance for QA approval.
8. DEFINITIONS/ABBREVIATIONS
8.1 Qualification: The documented process of verifying that equipment operates correctly and consistently within specified limits.
8.2 DQ: Design Qualification.
8.3 IQ: Installation Qualification.
8.4 OQ: Operational Qualification.
8.5 PQ: Performance Qualification.
8.6 cGMP: Current Good Manufacturing Practice
8.7 SOP: Standard Operating Procedure
8.8 QA: Quality Assurance
9. ANNEXES
9.1 Annex-1: Qualification Checklist.
| Item | Requirement/Standard | Observations Yes/No | Verified By | Date | Remarks |
| Tank material verification | Confirm grade (e.g., SS 316) | ||||
| Volume capacity | Verify design capacity | ||||
| Surface finish | Check smoothness (Ra ≤ 0.6 µm) | ||||
| Weld joints | Ensure proper welding, polish | ||||
| Agitator functionality | Verify motor operation | ||||
| CIP system | Check spray balls and coverage | ||||
| Utilities connection | Verify inlet/outlet systems | ||||
| Documentation | Review and sign qualification report |
9.2 Annex-2: Calibration Log.
| Instrument/Equipment | Identification No. | Last Calibrated Date | Calibration Due Date | Calibration Status (Pass/Fail) | Verified By | Remarks |
| Temperature probe | ||||||
| Pressure gauge | ||||||
| pH meter | ||||||
| Flow meter | ||||||
| Load cells | ||||||
| Conductivity sensor |
9.3 Annex-3: Deviation Report Template.
| Deviation Report No.: | DR/00/25 |
| Date: | |
| Reported by: | Sign: Date: |
| Reported Department: | |
| Deviation Descriptions: | |
| Potential Impact on Qualification Activities: | |
| Immediate Actions Taken: | |
| Root Cause Analysis: | |
| Corrective and Preventive Actions (CAPA): | |
| Comments: | |
| Reviewed by: | Sign: Date: |
| Approved by: (Head of QA) | Sign: Date: |
10. Revision History
| Version | Date | Description of Change | Reviewed By | Approved By |
| 1.0 |
Abdus Sobhan Salim is professional experienced pharmacist in pharmaceuticals, author and founder of pharmabossbd.com, the Bangladeshi pharmaceutical blogger since 2019.
