Standard Operating Procedure for QA Oversight During Equipment Qualification
| Department | Tablet |
|---|---|
| SOP No. | SOP/TAB/224/2025 |
| Supersedes | SOP/TAB/224/2022 |
| Page No. | Page 1 of 5 |
| Issue Date | 01/03/2026 |
| Effective Date | 06/03/2026 |
| Review Date | 01/03/2027 |
1. Purpose
The purpose of this SOP is to establish the procedures for ensuring that Quality Assurance (QA) is involved in equipment qualification throughout the tablet manufacturing process. This ensures that equipment operates within the required specifications and meets both regulatory and internal quality standards.
2. Scope
This SOP applies to all equipment used in tablet manufacturing processes, including mixing, granulation, compression, coating, and packaging equipment. It covers all stages of equipment qualification, including Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ).
3. Responsibilities
- QA Manager: Responsible for overseeing the equipment qualification process, ensuring proper documentation, and ensuring compliance with regulatory standards.
- Production Team: Responsible for performing qualification activities and ensuring that equipment operates according to the specified requirements.
- Engineering Team: Responsible for assisting in the installation, calibration, and troubleshooting of equipment and ensuring that all equipment is in good working condition during the qualification process.
- Regulatory Affairs Team: Ensures that the equipment qualification process meets all applicable regulatory requirements.
4. Accountability
The QA Manager is accountable for ensuring the QA oversight during equipment qualification. The Engineering and Production teams are responsible for carrying out the qualification activities, while the QA team ensures compliance and provides guidance throughout the process.
5. Procedure
5.1 Pre-Qualification Preparation
- Review the equipment specifications, installation manual, and user requirements document (Annexure-1) to understand the operational limits and expected performance.
- Ensure that the necessary calibration tools, test equipment, and qualified personnel are available before initiating the qualification process.
- Review the equipment supplier’s qualification documentation and previous service records to ensure compliance with industry standards.
5.2 Installation Qualification (IQ)
- Verify that the equipment has been installed according to the manufacturer’s specifications and that it is in the correct location (Annexure-2).
- Ensure that all equipment is properly connected to utilities (e.g., power, water, compressed air) and that safety features are fully operational.
- Document the completion of the installation, including photographs and installation checklists (Annexure-3).
- Ensure that all equipment documentation is available, including operator manuals, safety protocols, and maintenance schedules.
5.3 Operational Qualification (OQ)
- Verify that the equipment operates according to the specified operational limits and performs as expected under normal operating conditions (Annexure-4).
- Test all control features, alarms, and safety systems to ensure they function properly.
- Document all OQ testing results, including any deviations or failures, and report them to the QA department (Annexure-5).
- Ensure that the equipment is capable of operating consistently within the required parameters for tablet manufacturing.
5.4 Performance Qualification (PQ)
- Conduct performance qualification tests to verify that the equipment consistently produces product within the required quality specifications under actual operating conditions (Annexure-6).
- Monitor the equipment performance for stability and reliability over a defined batch size or period.
- Document the performance results, including any adjustments or corrective actions taken, and ensure they are reviewed and approved by QA (Annexure-7).
5.5 Documentation and Record Keeping
- Ensure that all qualification documents, including IQ, OQ, and PQ records, are completed, signed, and filed according to the company’s document control procedures (Annexure-8).
- Store all qualification records for a minimum of 5 years or as required by regulatory guidelines.
- Ensure that all equipment qualification records are accessible for audits and inspections.
5.6 Ongoing Monitoring and Re-Qualification
- Monitor equipment performance during routine use to ensure continued compliance with operational limits (Annexure-9).
- Re-qualify the equipment after any significant repairs, upgrades, or changes in operating conditions that could impact equipment performance.
- Document any re-qualification activities and maintain the records in the appropriate equipment qualification file.
6. Abbreviations
- SOP: Standard Operating Procedure
- QA: Quality Assurance
- OQ: Operational Qualification
- PQ: Performance Qualification
- IQ: Installation Qualification
7. Documents
- Equipment Qualification Report (Annexure-1)
- Installation Qualification Checklist (Annexure-2)
- Installation Verification Report (Annexure-3)
- Operational Qualification Test Plan (Annexure-4)
- Operational Qualification Test Results (Annexure-5)
- Performance Qualification Test Plan (Annexure-6)
- Performance Qualification Test Results (Annexure-7)
- Qualification Documentation Log (Annexure-8)
- Ongoing Equipment Monitoring Log (Annexure-9)
8. References
- 21 CFR Part 211 – Current Good Manufacturing Practice for Finished Pharmaceuticals (US FDA)
- ISO 9001 – Quality Management Systems
- GMP Guidelines for Pharmaceutical Manufacturing
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 Qualification Report
| Equipment | Model | Serial Number | Manufacturer | Qualification Date |
|---|---|---|---|---|
| Tablet Press | Model A | 123456 | Manufacturer ABC | 01/03/2026 |
Annexure-2: Installation Qualification Checklist
| Item | Specification | Pass/Fail | Comments |
|---|---|---|---|
| Power Supply | 220V, 50Hz | Pass | Connected and tested |
Annexure-3: Installation Verification Report
| Equipment | Location | Installed By | Verification Date |
|---|---|---|---|
| Tablet Press | Production Area 1 | John Smith | 01/03/2026 |
Annexure-4: Operational Qualification Test Plan
| Test | Specification | Acceptance Criteria |
|---|---|---|
| Tablet Hardness | 30 N | Pass |
Annexure-5: Operational Qualification Test Results
| Test | Result | Pass/Fail |
|---|---|---|
| Tablet Hardness | 31 N | Pass |
Annexure-6: Performance Qualification Test Plan
| Test | Specification | Acceptance Criteria |
|---|---|---|
| Tablet Weight | 500 mg | ±5% of specification |
Annexure-7: Performance Qualification Test Results
| Test | Result | Pass/Fail |
|---|---|---|
| Tablet Weight | 510 mg | Pass |
Annexure-8: Qualification Documentation Log
| Document Type | Storage Location | Retention Period |
|---|---|---|
| Qualification Report | QA Archive | 5 years |
Annexure-9: Ongoing Equipment Monitoring Log
| Monitoring Parameter | Frequency | Action Taken |
|---|---|---|
| Tablet Hardness | Daily | Adjusted pressure |
Revision History:
| Revision Date | Revision No. | Revision Details | Reason for Revision | Approved By |
|---|---|---|---|---|
| 01/01/2024 | 1.0 | Initial SOP creation | New process | QA Head |
| 01/02/2025 | 2.0 | Added requalification and ongoing monitoring procedures | Process improvement | QA Head |