Performance Qualification Protocol for Thermoform Blister Packing Machine
Document Control Number: PQ-OSD-001
Version: 1.0
Effective Date: YYYY-MM-DD
Reviewed By: [Name]
Approval Date: YYYY-MM-DD
Objective
The objective of this Performance Qualification (PQ) protocol is to validate the Thermoform Blister Packing Machine to ensure it operates within specified parameters to produce quality blister packs for tablets and capsules.
Scope
This protocol applies to the Thermoform Blister Packing Machine located in the Packaging/Primary area of the facility, intended for direct impact on product quality.
Responsibilities
The Validation Team is responsible for executing the PQ protocol, documenting results, and ensuring compliance with regulatory requirements.
The Quality Assurance Team will review and approve the protocol and results.
Prerequisites
1. Installation Qualification (IQ) must be completed and approved.
2. Operational Qualification (OQ) must be completed and approved.
3. Personnel must be trained on the operation of the blister packing machine.
Equipment Description
The Thermoform Blister Packing Machine is designed to form, fill, and seal blister packs for solid dosage forms such as tablets and capsules. Key critical parameters include:
- Forming Temperature
- Sealing Temperature
- Dwell Time
- Pressure
- Reject PLC
Test Plan
| Test ID | Procedure | Acceptance Criteria | Evidence |
|---|---|---|---|
| PQ-001 | Measure and record forming temperature | Within specified range as per URS Annex11 | Temperature logs |
| PQ-002 | Measure and record sealing temperature | Within specified range as per URS Annex11 | Temperature logs |
| PQ-003 | Measure dwell time | Within specified range as per URS Annex11 | Dwell time records |
| PQ-004 | Measure sealing pressure | Within specified range as per URS Annex11 | Pressure logs |
| PQ-005 | Verify reject PLC functionality | 100% rejection of defective packs | PLC test results |
Detailed Test Cases
Test Case PQ-001: Forming Temperature
Procedure: Set the machine to the specified forming temperature and allow it to stabilize. Measure using calibrated thermocouples.
Acceptance Criteria: Temperature must be within the range defined in URS Annex11.
Evidence: Record all temperature readings and compare against acceptance criteria.
Test Case PQ-002: Sealing Temperature
Procedure: Set the machine to the specified sealing temperature and allow it to stabilize. Measure using calibrated thermocouples.
Acceptance Criteria: Temperature must be within the range defined in URS Annex11.
Evidence: Record all temperature readings and compare against acceptance criteria.
Test Case PQ-003: Dwell Time
Procedure: Set the dwell time and measure using a stopwatch. Verify against set parameters.
Acceptance Criteria: Dwell time must be within the range defined in URS Annex11.
Evidence: Record dwell time and compare against acceptance criteria.
Test Case PQ-004: Sealing Pressure
Procedure: Measure sealing pressure using a calibrated gauge during operation.
Acceptance Criteria: Pressure must be within the range defined in URS Annex11.
Evidence: Record pressure readings and compare against acceptance criteria.
Test Case PQ-005: Reject PLC Functionality
Procedure: Run a test batch and intentionally introduce defects. Verify that the PLC rejects defective packs.
Acceptance Criteria: 100% of defective packs must be rejected.
Evidence: Document PLC response and rejection rate.
Deviations
Any deviations from the acceptance criteria must be documented and investigated. A root cause analysis will be conducted, and corrective actions will be implemented as necessary.
Approvals
Prepared By: ______________________ Date: ____________
Reviewed By: ______________________ Date: ____________
Approved By: ______________________ Date: ____________
Data Integrity Checks
1. Ensure all temperature and pressure logs are automatically saved with timestamps.
2. Implement user access controls to restrict unauthorized changes to the data.
3. Regularly back up data to prevent loss.