Design Qualification Protocol for Suppository Molding Machine
Document Number: DQ-001
Version: 1.0
Effective Date: [Insert Date]
Review Date: [Insert Date]
Prepared By: [Name]
Approved By: [Name]
Objective
The objective of this Design Qualification (DQ) protocol is to ensure that the Suppository Molding Machine is designed and installed in compliance with user requirements and regulatory standards, specifically URS, Annex 11, and Annex 15.
Scope
This protocol applies to the Suppository Molding Machine used in the production area for filling melted base into molds, impacting the quality of the final product directly.
Responsibilities
The Validation Team is responsible for executing the DQ protocol, while the Quality Assurance team will review and approve the documentation.
Prerequisites
All personnel involved must be trained in validation procedures and have a thorough understanding of the equipment and its intended use.
Equipment Description
The Suppository Molding Machine is designed to fill melted base into molds with precision and efficiency. Key features include temperature control, PLC integration, and automated cooling systems.
Test Plan
| Test ID | Procedure | Acceptance Criteria | Evidence |
|---|---|---|---|
| T1 | Verify fill volume accuracy | ±5% of target fill volume | Calibration records |
| T2 | Measure mold temperature | Within specified range | Temperature logs |
| T3 | Cooling time assessment | As per defined cooling protocol | Cooling logs |
| T4 | PLC logs review | Complete audit trail | PLC logs |
Detailed Test Cases
Test Case T1: Fill volume accuracy will be verified by filling molds with a calibrated syringe and measuring the actual volume against the target.
Test Case T2: Mold temperature will be monitored using calibrated thermocouples to ensure it remains within the specified range during operation.
Test Case T3: Cooling time will be recorded to ensure it meets the defined cooling protocol to prevent product degradation.
Test Case T4: PLC logs will be reviewed for completeness and accuracy, ensuring all operations are documented properly.
Deviations
Any deviations from the acceptance criteria must be documented and justified. A corrective action plan should be initiated for significant deviations.
Approvals
Prepared By: [Name] – [Position]
Date: [Insert Date]
Approved By: [Name] – [Position]
Date: [Insert Date]
Data Integrity Checks
All data generated during the validation process will be subject to the following integrity checks:
- Ensure all logs are timestamped and secured against unauthorized access.
- Regular backups of PLC logs and temperature data.
- Periodic review of data entries for accuracy and completeness.