Document Number: DQ-001
Version: 1.0
Effective Date: 2023-10-01
Reviewed By: [Reviewer Name]
Approval Date: [Approval Date]
Design Qualification Protocol for Crimping Machine in Nasal & Otic Product Production
Objective
The objective of this Design Qualification (DQ) protocol is to ensure that the Crimping Machine (Pump Fixing) used in the production of Nasal & Otic products meets the required specifications and operates correctly to ensure product quality and compliance with URS Annex11.
Scope
This protocol applies to the Crimping Machine used in the production area specifically for fixing spray pumps to bottles for both sterile and non-sterile nasal and otic products.
Responsibilities
The Validation Team is responsible for the execution of this protocol, while the Quality Assurance (QA) department will oversee the compliance and approval process.
Prerequisites
- Completion of User Requirement Specification (URS)
- Installation Qualification (IQ) completed
- Operational Qualification (OQ) completed
Equipment Description
The Crimping Machine is designed to securely attach spray pumps to bottles. It operates under controlled conditions to ensure consistent crimping force, critical for maintaining product integrity.
Test Plan
| Test ID | Procedure | Acceptance Criteria | Evidence |
|---|---|---|---|
| T1 | Verify crimp force torque settings | Within specified range as per URS Annex11 | Audit trail logs |
| T2 | Check crimping machine calibration | Calibration certificate within last 12 months | Calibration certificate |
| T3 | Review audit trail logs | Complete logs available for review | Log files |
Detailed Test Cases
Test Case T1: Verify Crimp Force Torque Settings
Procedure: Set the crimping machine to the specified torque settings and perform crimping on a sample batch. Measure the crimp force using calibrated equipment.
Acceptance Criteria: Crimp force must be within the specified range as per URS Annex11. Document findings in the test report.
Test Case T2: Check Crimping Machine Calibration
Procedure: Obtain the calibration certificate for the crimping machine and verify the date and accuracy of calibration.
Acceptance Criteria: Certificate must indicate calibration within the last 12 months. Document findings in the test report.
Test Case T3: Review Audit Trail Logs
Procedure: Access the crimping machine’s audit trail logs and verify the completeness and accuracy of the records.
Acceptance Criteria: All logs must be complete and available for review. Document findings in the test report.
Deviations
Any deviations from the acceptance criteria must be documented and justified in a deviation report. Corrective actions must be identified and implemented.
Approvals
Prepared By: [Preparer Name]
Approved By: [Approver Name]
Signature: _____________________
Date: _____________________