Document Control Number: PQ-OSD-001
Version: 1.0
Effective Date: [Insert Date]
Reviewed By: [Insert Name]
Approval Date: [Insert Date]
Performance Qualification Protocol for Bottle Unscrambler in Solid Dosage Form
This document outlines the Performance Qualification (PQ) protocol for the Bottle Unscrambler used in the Packaging/Primary area for solid dosage forms.
Objective: To ensure that the Bottle Unscrambler operates consistently and performs according to established acceptance criteria to maintain product quality and safety.
Scope: This protocol applies to the Bottle Unscrambler used in the packaging of solid dosage forms, specifically focusing on its performance qualification.
Responsibilities:
- Validation Team: Responsible for executing the PQ protocol and documenting results.
- Quality Assurance: Responsible for reviewing and approving the PQ protocol and results.
- Operations: Responsible for ensuring the equipment is maintained and operated according to SOPs.
Prerequisites:
- Completion of Installation Qualification (IQ) and Operational Qualification (OQ).
- Availability of all necessary documentation including URS and SOPs.
Equipment Description: The Bottle Unscrambler is designed to feed and orient bottles for further packaging processes. It includes speed jam sensors and interlocks to ensure safe operation.
| Test ID | Procedure | Acceptance Criteria | Evidence |
|---|---|---|---|
| PQ-01 | Verify speed settings under normal operation. | Speed must be within specified range as per URS. | Calibration report and observation log. |
| PQ-02 | Test jam sensors and interlocks. | All sensors must trigger alarms and stop the machine. | Test log and sensor activation report. |
Detailed Test Cases:
- Test Case PQ-01: Set the Bottle Unscrambler to the specified speed and monitor for a duration of 30 minutes. Record any deviations from the set speed.
- Test Case PQ-02: Simulate a jam condition and verify that the sensors activate and the machine stops within 5 seconds. Document the results.
Deviations: Any deviations encountered during the PQ shall be documented in the deviation log and reviewed by the Quality Assurance team for appropriate action.
Approvals:
- Prepared By: [Insert Name]
- Reviewed By: [Insert Name]
- Approved By: [Insert Name]