Document ID: DQ-001
Version: 1.0
Effective Date: 2023-10-01
Reviewed By: [Name]
Approval Date: [Date]
Design Qualification Protocol for Coding Machine in Packaging Operations
Objective: To establish a Design Qualification (DQ) protocol for the Coding Machine used in the printing of batch and expiry details on suppositories and implants, ensuring compliance with regulatory standards and product quality.
Scope: This protocol applies to the Coding Machine (Inkjet / Laser) utilized in the packaging area for the direct impact on product quality of suppositories and implants.
Responsibilities:
- Validation Team: Responsible for the execution of the DQ protocol.
- Quality Assurance: Responsible for review and approval of the DQ protocol.
- Operations: Responsible for the operation of the Coding Machine and adherence to the protocol.
Prerequisites:
- Completion of User Requirement Specification (URS) as per Annex 11.
- Installation and operational qualification of the Coding Machine.
Equipment Description: The Coding Machine (Inkjet / Laser) is designed for printing batch and expiry details on packaging materials for suppositories and implants, ensuring high print quality and compliance with regulatory requirements.
| Test ID | Procedure | Acceptance Criteria | Evidence |
|---|---|---|---|
| T1 | Verify print quality through audit trail logs. | Print quality meets specifications as per URS Annex 11. | Print quality audit logs. |
| T2 | Conduct data integrity checks on printed information. | All printed data corresponds accurately with batch records. | Comparison report of printed data vs. batch records. |
Detailed Test Cases:
- Test ID: T1
- Procedure: Review print quality audit trail logs for accuracy.
- Acceptance Criteria: Print quality meets specifications as per URS Annex 11.
- Evidence: Documented print quality logs showing compliance.
- Test ID: T2
- Procedure: Verify that printed batch/expiry details match the batch records.
- Acceptance Criteria: All printed data corresponds accurately with batch records.
- Evidence: Comparison report of printed data vs. batch records.
Deviations: Any deviations from the acceptance criteria must be documented and assessed for impact on product quality. Corrective actions should be implemented as necessary.
Approvals:
- Validation Team: ___________________ Date: ___________
- Quality Assurance: ___________________ Date: ___________
- Operations Manager: ___________________ Date: ___________