Document ID: IQ-TDS-001
Version: 1.0
Effective Date: [Insert Date]
Reviewed By: [Insert Name]
Approval Date: [Insert Date]
Installation Qualification Protocol for Patch Coating Machine
Objective: To ensure that the Patch Coating Machine is installed correctly and functions according to specifications for the coating of drug adhesive layers onto backing films.
Scope: This protocol applies to the Installation Qualification of the Patch Coating Machine used in the production of transdermal patches.
Responsibilities:
- Validation Team: Prepare and execute the IQ protocol.
- Production Team: Provide access to the equipment and assist in the execution of tests.
- Quality Assurance: Review and approve the IQ protocol and results.
Prerequisites:
- Completion of equipment installation.
- Training of personnel on equipment operation.
- Availability of required documentation (URS, specifications).
Equipment Description:
The Patch Coating Machine (Knife-over-roll / Slot Die) is designed for the application of drug adhesive layers onto backing films with critical parameters including coating thickness, speed, temperature, tension, and PLC logs.
| Test ID | Procedure | Acceptance Criteria | Evidence |
|---|---|---|---|
| IQ-01 | Verify equipment installation against manufacturer specifications. | All components installed as per specifications. | Installation checklist signed off. |
| IQ-02 | Check calibration of critical parameters (thickness, speed, temp, tension). | Parameters within specified limits. | Calibration certificates. |
| IQ-03 | Review PLC logs for accuracy and completeness. | Logs show no discrepancies. | PLC log printouts. |
Detailed Test Cases:
- Test Case ID: IQ-01
- Objective: Confirm proper installation.
- Procedure: Inspect all physical components.
- Acceptance: All components installed correctly.
- Evidence: Installation checklist.
- Test Case ID: IQ-02
- Objective: Validate calibration.
- Procedure: Measure coating thickness, speed, temperature, and tension.
- Acceptance: All readings within specified limits.
- Evidence: Calibration certificates.
- Test Case ID: IQ-03
- Objective: Ensure PLC logs are accurate.
- Procedure: Review PLC logs for discrepancies.
- Acceptance: No discrepancies found.
- Evidence: PLC log printouts.
Deviations: Any deviations from the acceptance criteria must be documented and addressed as per the change control procedure.
Approvals:
- Validation Team Lead: ___________________ Date: __________
- Production Manager: ___________________ Date: __________
- Quality Assurance: ___________________ Date: __________
Data Integrity Checks:
- Ensure all PLC logs are securely stored and backed up.
- Conduct periodic reviews of calibration data to maintain compliance.
- Implement access controls to prevent unauthorized changes to critical parameters.