Document ID: IQ-BPM-001
Version: 1.0
Effective Date: [Insert Date]
Prepared By: [Insert Name]
Approved By: [Insert Name]
Installation Qualification Protocol for Blister Packing Machine
Objective: To verify that the Blister Packing Machine (Thermoform) is installed correctly and operates according to specified requirements for the packaging of solid dosage forms.
Scope: This protocol applies to the Installation Qualification of the Blister Packing Machine located in the Packaging/Primary area, which is utilized for blister packing tablets and capsules.
Responsibilities:
- Validation Team: Responsible for executing the IQ protocol and documenting results.
- Quality Assurance: Responsible for reviewing and approving the protocol and results.
- Engineering: Responsible for providing technical support during the qualification process.
Prerequisites:
- Installation of the Blister Packing Machine must be completed.
- All utilities (water, electricity, air) must be verified and functional.
- All necessary documentation (URS, design specifications) must be available.
Equipment Description:
The Blister Packing Machine (Thermoform) is designed for the efficient and reliable packaging of tablets and capsules in blister packs. Key critical parameters include:
- Forming Temperature
- Sealing Temperature
- Dwell Time
- Pressure
- Reject PLC
| Test ID | Procedure | Acceptance Criteria | Evidence |
|---|---|---|---|
| IQ-01 | Verify installation of the machine components as per manufacturer specifications. | All components installed as per specifications. | Installation checklist signed by the engineering team. |
| IQ-02 | Check utility connections (water, air, electricity). | All utilities functional and meet specifications. | Utility verification report. |
| IQ-03 | Perform a calibration check on critical parameters. | All parameters within defined limits. | Calibration certificates and test results. |
| IQ-04 | Conduct a dry run of the machine. | Machine operates without errors. | Dry run report. |
Detailed Test Cases:
- Test ID: IQ-01: Confirm that all machine components are installed according to the manufacturer’s specifications. Document any discrepancies.
- Test ID: IQ-02: Verify that all utility connections are functional. Log any issues encountered during verification.
- Test ID: IQ-03: Ensure calibration of critical parameters (forming temp, sealing temp, dwell pressure) is within acceptance limits. Record calibration data.
- Test ID: IQ-04: Execute a dry run to validate operational functionality. Document any errors or malfunctions.
Deviations: Any deviations from the acceptance criteria must be documented in the deviation log and assessed for impact on the validation process.
Approvals:
- Prepared By: ____________________ Date: _____________
- Reviewed By: ____________________ Date: _____________
- Approved By: ____________________ Date: _____________
Data Integrity Checks:
- Ensure that all data logged during testing is securely stored and backed up.
- Verify that all electronic records are timestamped and attributed to the individual performing the test.
- Conduct periodic reviews of data logs to ensure completeness and accuracy.