Document Number: PQ-CP-001
Version: 1.0
Effective Date: YYYY-MM-DD
Reviewed By: [Name]
Approval Date: YYYY-MM-DD
Performance Qualification Protocol for Capsule Polisher
Objective: To validate the performance of the Capsule Polisher to ensure it meets the required specifications for polishing and dedusting capsules.
Scope: This protocol applies to the Capsule Polisher used in the production area for solid dosage forms, specifically for the polishing and dedusting of capsules.
Responsibilities:
- Validation Team: Responsible for executing the PQ protocol and documenting results.
- Quality Assurance: Responsible for reviewing and approving the PQ protocol and results.
- Production Personnel: Responsible for operating the Capsule Polisher during testing.
Prerequisites:
- Completion of Installation Qualification (IQ) and Operational Qualification (OQ).
- Availability of necessary equipment and materials for testing.
- Training of personnel on the operation of the Capsule Polisher.
Equipment Description: The Capsule Polisher is designed to polish and dedust capsules after filling, ensuring a clean and high-quality final product. Key features include adjustable speed and airflow settings.
| Test ID | Procedure | Acceptance Criteria | Evidence |
|---|---|---|---|
| PQ-CP-01 | Measure airflow at various speed settings. | Airflow must remain within specified limits. | Calibration records and airflow measurements. |
| PQ-CP-02 | Assess capsule damage post-polishing. | No more than 1% of capsules may show damage. | Visual inspection reports. |
Detailed Test Cases:
- Test ID: PQ-CP-01
Procedure: Adjust the Capsule Polisher to different speed settings (low, medium, high). Measure and record the airflow using an anemometer.
Acceptance Criteria: Airflow must be consistent with the manufacturer’s specifications across all settings.
Evidence: Documented airflow readings and calibration certificates.
- Test ID: PQ-CP-02
Procedure: Run a batch of capsules through the polisher. Conduct a visual inspection of the capsules for any signs of damage.
Acceptance Criteria: No more than 1% of capsules should exhibit any damage.
Evidence: Inspection logs and photographs of inspected capsules.
Deviations: Any deviations from the protocol must be documented and justified. A deviation report should be generated and reviewed by Quality Assurance.
Approvals:
- _________________________ (Validation Team)
- _________________________ (Quality Assurance)
- _________________________ (Production Manager)