Document Control Number: DQ-OSP-001
Version: 1.0
Effective Date: [Insert Date]
Reviewed By: [Insert Name]
Approval Date: [Insert Date]
Design Qualification Protocol for Strip Packing Machine
Objective: To establish and document the Design Qualification (DQ) of the Strip Packing Machine used for packaging solid dosage forms, ensuring compliance with regulatory requirements and product specifications.
Scope: This protocol applies to the Design Qualification of the Strip Packing Machine within the Packaging/Primary area for solid dosage forms. It covers the validation of critical parameters impacting product quality and integrity.
Responsibilities:
- Validation Team: Responsible for the execution of the DQ protocol and documentation of results.
- Quality Assurance: Responsible for reviewing and approving the DQ protocol and results.
- Engineering: Responsible for ensuring the equipment is installed and operational as per specifications.
Prerequisites:
- Installation Qualification (IQ) must be completed prior to DQ.
- Operational Qualification (OQ) is planned following DQ.
Equipment Description:
The Strip Packing Machine is designed for the packaging of solid dosage forms into strip packs. It operates with critical parameters including sealing temperature, dwell time, pressure, registration, and reject functionality.
| Test ID | Procedure | Acceptance Criteria | Evidence |
|---|---|---|---|
| DQ-01 | Verify sealing temperature settings. | Must be within specified range as per URS Annex11. | Calibration certificates. |
| DQ-02 | Check dwell time functionality. | Dwell time must meet specifications. | Operational logs. |
| DQ-03 | Validate pressure settings. | Pressure must be within specified limits. | Pressure gauge readings. |
| DQ-04 | Assess registration accuracy. | Registration must align with product specifications. | Visual inspection records. |
| DQ-05 | Evaluate reject functionality. | Reject mechanism must function correctly. | Test run results. |
Detailed Test Cases:
- Test Case DQ-01: Set sealing temperature to specified value and verify with thermometer.
- Test Case DQ-02: Run the machine to confirm dwell time is as per specifications using a timer.
- Test Case DQ-03: Use calibrated pressure gauge to measure operational pressure during a test run.
- Test Case DQ-04: Conduct a visual inspection of the product alignment post-packaging.
- Test Case DQ-05: Perform a simulated reject cycle to ensure the reject mechanism operates correctly.
Deviations: Any deviations from the acceptance criteria must be documented and justified. A corrective action plan must be implemented and approved by Quality Assurance.
Approvals:
- ____________________ (Validation Team Lead)
- ____________________ (Quality Assurance)
- ____________________ (Engineering)
Data Integrity Checks: Ensure all data generated during the DQ process is securely stored, backed up, and accessible only to authorized personnel. Regular audits of data entries and logs will be conducted to maintain compliance.