Design Qualification Protocol for Capsule Polisher in Solid Dosage Form Production
Document Number: DQ-CP-001
Version: 1.0
Date: 2023-10-01
Prepared by: [Your Name]
Reviewed by: [Reviewer Name]
Approved by: [Approver Name]
Objective
The objective of this Design Qualification (DQ) protocol is to ensure that the Capsule Polisher is designed and installed in compliance with the User Requirements Specification (URS) and is capable of performing its intended function effectively.
Scope
This protocol applies to the Capsule Polisher used in the production area for polishing and dedusting capsules as part of the solid dosage form manufacturing process.
Responsibilities
- Validation Team: Responsible for preparing, executing, and documenting the DQ protocol.
- Quality Assurance: Responsible for reviewing and approving the DQ protocol and associated documentation.
- Production Team: Responsible for providing input on operational requirements and participating in the testing process.
Prerequisites
- Completion of the User Requirements Specification (URS).
- Installation of the Capsule Polisher in the designated production area.
- Training of personnel on the operation of the Capsule Polisher.
Equipment Description
The Capsule Polisher is designed to polish and dedust capsules post-production. It operates using controlled airflow to ensure minimal damage to the capsules while maintaining efficiency in the polishing process. The key critical parameters include speed, airflow, and potential capsule damage.
Test Plan
| Test ID | Procedure | Acceptance Criteria | Evidence |
|---|---|---|---|
| DQ-CP-01 | Verify installation against URS requirements. | All URS requirements must be met. | Installation checklist. |
| DQ-CP-02 | Test airflow speed during operation. | Airflow speed must be within specified limits. | Airflow measurement logs. |
| DQ-CP-03 | Assess capsule damage during polishing. | No visible damage on 100% of capsules. | Visual inspection reports. |
Detailed Test Cases
Test Case DQ-CP-01
Objective: Verify installation against URS requirements.
Procedure: Review installation documentation and compare against the URS.
Acceptance Criteria: All URS requirements must be met.
Evidence: Installation checklist signed by validation team.
Test Case DQ-CP-02
Objective: Test airflow speed during operation.
Procedure: Measure airflow speed using calibrated equipment during operation.
Acceptance Criteria: Airflow speed must be within specified limits.
Evidence: Airflow measurement logs with date and time stamps.
Test Case DQ-CP-03
Objective: Assess capsule damage during polishing.
Procedure: Perform visual inspection of capsules post-polishing.
Acceptance Criteria: No visible damage on 100% of capsules.
Evidence: Visual inspection reports with photographs.
Deviations
Any deviations from the acceptance criteria must be documented, investigated, and resolved prior to final approval of the DQ protocol.
Approvals
All sections of this DQ protocol must be reviewed and approved by the Quality Assurance and Validation Team before implementation.