Design Qualification (DQ) Protocol for Thermoform Blister Packing Machine
Document Control:
- Document Number: DQ-OSD-001
- Version: 1.0
- Effective Date: [Insert Date]
- Reviewed by: [Insert Name]
- Approved by: [Insert Name]
Objective
The objective of this Design Qualification (DQ) protocol is to establish documented evidence that the Blister Packing Machine (Thermoform) is designed and installed according to the specified requirements and is suitable for its intended use in the packaging of tablets and capsules.
Scope
This protocol applies to the Design Qualification of the Blister Packing Machine used in the Packaging/Primary area for solid dosage forms (OSD) with direct product impact.
Responsibilities
The following personnel are responsible for the execution of this DQ protocol:
- Validation Team: Ensure compliance with validation requirements.
- Quality Assurance: Review and approve the DQ protocol and results.
- Engineering: Provide technical support and equipment specifications.
Prerequisites
Prior to executing this protocol, the following prerequisites must be met:
- Completion of User Requirements Specification (URS) for the equipment.
- Installation of the Blister Packing Machine in the designated area.
- Completion of any necessary training for personnel operating the equipment.
Equipment Description
The Blister Packing Machine (Thermoform) is designed to produce blister packs for tablets and capsules. It operates under the following critical parameters:
- Forming Temperature
- Sealing Temperature
- Dwell Pressure
- Reject PLC
Test Plan
| Test ID | Procedure | Acceptance Criteria | Evidence |
|---|---|---|---|
| DQ-TP-001 | Verify forming temperature settings | Forming temperature within specified range | Calibration certificate |
| DQ-TP-002 | Check sealing temperature settings | Sealing temperature within specified range | Calibration certificate |
| DQ-TP-003 | Validate dwell pressure settings | Dwell pressure within specified range | Calibration certificate |
| DQ-TP-004 | Test reject PLC functionality | Reject PLC operates as intended | Test report |
Detailed Test Cases
Test Case DQ-TC-001
Objective: Verify the forming temperature settings.
Procedure: Adjust the forming temperature to the specified setting and record the actual temperature.
Expected Result: The forming temperature should be within the specified range.
Test Case DQ-TC-002
Objective: Check the sealing temperature settings.
Procedure: Adjust the sealing temperature to the specified setting and record the actual temperature.
Expected Result: The sealing temperature should be within the specified range.
Test Case DQ-TC-003
Objective: Validate the dwell pressure settings.
Procedure: Adjust the dwell pressure to the specified setting and record the actual pressure.
Expected Result: The dwell pressure should be within the specified range.
Test Case DQ-TC-004
Objective: Test reject PLC functionality.
Procedure: Simulate a reject scenario and verify that the PLC operates as intended.
Expected Result: The reject PLC should function correctly and reject the defective product.
Deviations
Any deviations from the acceptance criteria must be documented and justified. A deviation report should be generated for review.
Approvals
The final DQ protocol and results will require approval from the Quality Assurance department and the Validation Team.