Document ID: DQ-001
Version: 1.0
Effective Date: 2023-10-01
Reviewed By: [Reviewer Name]
Approval Date: [Approval Date]
Design Qualification Protocol for Suppository Cutting Machine
Objective: To ensure that the Suppository Cutting Machine is properly qualified and meets the specified requirements for trimming excess material from suppositories and implants.
Scope: This protocol applies to the Design Qualification of the Suppository Cutting Machine located in the Production area, used for direct impact on product quality.
Responsibilities:
- Validation Team: Responsible for executing the DQ protocol and documenting results.
- Quality Assurance: Responsible for reviewing and approving the DQ protocol and results.
- Production Team: Responsible for the operation and maintenance of the equipment.
Prerequisites:
- Completion of User Requirement Specification (URS).
- Installation Qualification (IQ) of the equipment.
- Training of personnel on equipment operation.
Equipment Description:
The Suppository Cutting Machine is designed to trim excess material from suppositories and implants, ensuring uniformity and precision. It features adjustable cutting mechanisms to maintain cutting precision alignment, which is critical for product quality.
| Test ID | Procedure | Acceptance | Evidence |
|---|---|---|---|
| DQ-001-01 | Verify cutting precision alignment using calibrated measurement tools. | Alignment within ±0.5 mm of target specifications. | Calibration report and measurement records. |
| DQ-001-02 | Perform a visual inspection of cut products for uniformity. | 100% of samples meet visual inspection criteria. | Photographic evidence and inspection report. |
Detailed Test Cases:
Test Case DQ-001-01
Objective: To verify cutting precision alignment of the Suppository Cutting Machine.
Procedure: Use calibrated measurement tools to measure the alignment of cuts on a sample of suppositories.
Acceptance Criteria: Alignment must be within ±0.5 mm of target specifications.
Expected Results: All measurements are within the specified range.
Evidence: Calibration report and measurement records will be documented.
Test Case DQ-001-02
Objective: To ensure uniformity of the cut products.
Procedure: Conduct a visual inspection of 10 samples from the production batch.
Acceptance Criteria: 100% of samples must meet visual inspection criteria for uniformity.
Expected Results: All inspected samples appear uniform with no visible defects.
Evidence: Photographic evidence and inspection report will be documented.
Deviations:
Any deviations from the acceptance criteria must be documented and assessed for impact on product quality. Corrective actions must be implemented as necessary.
Approvals:
All results from this DQ protocol must be reviewed and approved by the Quality Assurance team prior to equipment use in production.