Procedure for Equipment Qualification in Ointment Manufacturing
| Department | Quality Assurance (QA)/Validation/Engineering/Production |
|---|---|
| SOP No. | SOP/Ointment/131 |
| 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 equipment qualification in ointment manufacturing. This ensures that all equipment used in production meets predefined operational, performance, and compliance requirements before use.
2. Scope
This SOP applies to all personnel in the Quality Assurance (QA), Validation, Engineering, and Production departments responsible for the qualification of new, modified, or relocated equipment in ointment manufacturing.
3. Responsibilities
- QA Officer: Ensures compliance with equipment qualification protocols.
- Validation Team: Develops qualification protocols and executes validation studies.
- Engineering Team: Supports installation and calibration of equipment.
- Production Supervisor: Ensures adherence to equipment qualification requirements.
- QA Manager: Approves final qualification reports and maintains documentation.
4. Accountability
The QA and Validation Managers are accountable for ensuring that all equipment used in ointment manufacturing undergoes proper qualification as per GMP, FDA, ICH, and WHO guidelines.
5. Procedure
5.1 Phases of Equipment Qualification
Equipment qualification follows four key phases:
- Design Qualification (DQ): Verification that the equipment design meets process requirements.
- Installation Qualification (IQ): Ensures the equipment is installed according to manufacturer specifications.
- Operational Qualification (OQ): Confirms the equipment functions
as intended under operating conditions.
Performance Qualification (PQ): Validates that the equipment consistently performs under real production conditions.
5.2 Design Qualification (DQ)
- Ensure equipment design meets GMP and process requirements.
- Review manufacturer specifications and functional requirements.
- Document risk assessments and compliance evaluations.
- Approve DQ report before proceeding to installation.
5.3 Installation Qualification (IQ)
- Verify that the equipment is installed in accordance with manufacturer guidelines.
- Ensure proper electrical, mechanical, and environmental setup.
- Confirm calibration and alignment with other production systems.
- Document all installation parameters in the IQ report.
5.4 Operational Qualification (OQ)
- Conduct test runs to confirm equipment operates within set parameters.
- Verify process variables, including:
- Temperature control
- Mixing speeds
- Homogenization efficiency
- Heating and cooling rates
- Document operational test results and corrective actions.
- Obtain approval for the OQ report before proceeding to performance qualification.
5.5 Performance Qualification (PQ)
- Perform test production batches using qualified equipment.
- Ensure consistency in:
- Batch uniformity
- Product viscosity and spreadability
- Filling precision and sealing integrity
- Document performance results and approve final qualification.
5.6 Requalification and Maintenance
- Conduct periodic requalification based on equipment usage and performance trends.
- Initiate requalification after major repairs or modifications.
- Ensure proper documentation of maintenance and calibration activities.
5.7 Documentation and Review
- Maintain all qualification reports in the Equipment Qualification Log.
- QA must review and approve all qualification records.
- Ensure data is available for regulatory audits.
6. Abbreviations
- GMP – Good Manufacturing Practices
- QA – Quality Assurance
- IQ – Installation Qualification
- OQ – Operational Qualification
- PQ – Performance Qualification
- DQ – Design Qualification
7. Documents
- Equipment Qualification Protocol (Annexure-1)
- Equipment Qualification Log (Annexure-2)
8. References
- ICH Q7 – Good Manufacturing Practice Guide
- WHO Guidelines for Equipment Qualification
- US FDA Guidance on Equipment Validation
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 Protocol
| Equipment Type | Qualification Phase | Test Parameter | Acceptance Criteria |
|---|---|---|---|
| Mixing Tank | OQ | Agitation Speed | ± 5% of set value |
| Filling Machine | PQ | Fill Volume Accuracy | ± 1% of target |
Annexure-2: Equipment Qualification Log
| Date | Equipment ID | Qualification Phase | Test Performed | Result | Reviewed By |
|---|---|---|---|---|---|
| 01/02/2025 | MIX-1001 | IQ | Installation Verification | Pass | QA Manager |
| 02/02/2025 | FILL-2002 | PQ | Batch Performance | 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 |