Document ID: PQ-OSD-TCCF-001
Version: 1.0
Effective Date: 2023-10-01
Reviewed By: [Name]
Approval Date: [Date]
Performance Qualification Protocol for Tablet and Capsule Counter Filler
Objective: To validate the performance of the Tablet/Capsule Counter Filler to ensure it meets specified requirements for counting and filling into bottles accurately and efficiently.
Scope: This protocol applies to the validation of the Tablet/Capsule Counter Filler used in the packaging of solid dosage forms within the primary packaging area.
Responsibilities:
- Validation Team: Ensure the execution of the PQ protocol and documentation of results.
- Quality Assurance: Review and approve the protocol and results.
- Operations: Provide access to the equipment and assist in execution of test cases.
Prerequisites:
- Completion of Installation Qualification (IQ) and Operational Qualification (OQ).
- Availability of required materials for testing.
- Training of personnel on the operation of the equipment.
Equipment Description: The Tablet/Capsule Counter Filler is designed for counting and filling solid dosage forms into bottles. It is capable of handling various tablet and capsule sizes with a focus on accuracy and speed.
| Test ID | Procedure | Acceptance Criteria | Evidence |
|---|---|---|---|
| PQ-001 | Verify counting accuracy with sample tablets/capsules. | Counting accuracy within ±1% of target. | Count report and audit trail. |
| PQ-002 | Measure fill speed during operation. | Fill speed meets specified URS requirements. | Speed test report. |
| PQ-003 | Check for rejects during counting and filling. | Reject rate ≤ 0.5%. | Reject logs and audit trail. |
Detailed Test Cases:
- Test Case PQ-001: Using a batch of 100 tablets, count and verify accuracy. Document the actual count and compare against the expected count.
- Test Case PQ-002: Measure the time taken to fill 100 bottles and calculate the fill speed. Ensure it meets the URS specifications.
- Test Case PQ-003: Monitor the reject count during a 1-hour operation. Document any discrepancies and the corresponding reasons.
Deviations: Any deviations from the acceptance criteria during testing must be documented in a deviation report and reviewed by the Quality Assurance team.
Approvals:
- Prepared By: [Name/Title]
- Reviewed By: [Name/Title]
- Approved By: [Name/Title]
Data Integrity Checks: Ensure that all data collected during the PQ process is logged into a secure electronic system with restricted access. Regular audits of the data should be conducted to verify integrity and compliance with regulatory standards.