Document Control:
Protocol Number: PQ-001
Version: 1.0
Effective Date: [Insert Date]
Review Date: [Insert Date]
Prepared by: [Insert Name]
Approved by: [Insert Name]
Performance Qualification Protocol for SIP System in Ophthalmics Production
Objective: To validate the SIP System used for sterilizing vessels and lines in the production of sterile eye drops and eye ointments, ensuring compliance with regulatory standards.
Scope: This protocol applies to the SIP System (Tanks/Lines) utilized in the production and sterilization area for ophthalmic products.
Responsibilities:
- Validation Team: Conducts the qualification activities and documentation.
- Quality Assurance: Reviews and approves the protocol and results.
- Production Team: Ensures equipment is maintained and operational during the qualification process.
Prerequisites:
- Completion of Installation Qualification (IQ).
- Operational Qualification (OQ) must be completed and documented.
- Availability of all necessary equipment and materials for testing.
Equipment Description: The SIP System consists of tanks and lines designed to sterilize equipment and materials used in the production of sterile ophthalmic products. The system operates under controlled temperature and pressure conditions.
| Test ID | Procedure | Acceptance Criteria | Evidence |
|---|---|---|---|
| PQ-01 | Temperature Verification | Temperature must be maintained within specified limits. | Temperature logs |
| PQ-02 | Pressure Verification | Pressure must be maintained within specified limits. | Pressure logs |
| PQ-03 | Hold Time Verification | Hold time must meet specified duration. | Hold time logs |
Detailed Test Cases:
- Test Case PQ-01: Verify that the temperature of the SIP System reaches and maintains the required sterilization temperature for the specified duration. Record temperature logs.
- Test Case PQ-02: Verify that the pressure of the SIP System is maintained at the required level throughout the sterilization cycle. Record pressure logs.
- Test Case PQ-03: Verify that the hold time is adhered to during the sterilization process. Record hold time logs.
Deviations: Any deviations from the acceptance criteria must be documented and investigated. A corrective action plan should be developed and implemented to address any issues.
Approvals:
- Prepared by: ___________________ Date: __________
- Reviewed by: ___________________ Date: __________
- Approved by: ___________________ Date: __________
Data Integrity Checks: Ensure that all logs are time-stamped, signed, and securely stored. Any changes to the data must be tracked and documented to maintain data integrity.