Document Control Number: PQ-OSD-CMD-001
Version: 1.0
Effective Date: 2023-10-01
Reviewed By: [Reviewer Name]
Approval Date: [Approval Date]
Performance Qualification Protocol for Capsule Metal Detector
Meta Description: This document outlines the Performance Qualification protocol for the Capsule Metal Detector used in Solid Dosage Form production, focusing on critical parameters and acceptance criteria.
Tags: Equipment Validation, Performance Qualification, Capsule Metal Detector, OSD
Objective
The objective of this Performance Qualification (PQ) protocol is to establish the operational effectiveness of the Capsule Metal Detector in detecting metal contaminants during the production of solid dosage forms.
Scope
This protocol applies to the Capsule Metal Detector used in the production area for capsule manufacturing. It covers the validation of the equipment’s ability to detect metal contaminants and ensure product safety and compliance.
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 Team: Responsible for the operation of the Capsule Metal Detector during testing.
Prerequisites
- Completion of Installation Qualification (IQ) and Operational Qualification (OQ) for the Capsule Metal Detector.
- Availability of relevant standard operating procedures (SOPs).
- Training of personnel on the operation of the Capsule Metal Detector.
Equipment Description
The Capsule Metal Detector is designed to identify and reject metal contaminants from capsules during the production process. It operates with a high sensitivity setting to ensure compliance with industry standards.
Test Plan
| Test ID | Procedure | Acceptance Criteria | Evidence |
|---|---|---|---|
| PQ-001 | Conduct sensitivity reject verification. | All metal contaminants are rejected with 100% accuracy. | Test report and audit trail. |
| PQ-002 | Verify audit trail functionality. | Audit trail logs all events accurately. | Generated audit trail report. |
Detailed Test Cases
Test Case 1: Sensitivity Reject Verification
Objective: To verify that the Capsule Metal Detector accurately rejects metal contaminants.
Procedure: Introduce known metal contaminants of varying sizes and materials into the capsule stream. Record the detector’s response.
Acceptance Criteria: All contaminants must be rejected without false positives.
Evidence: Documented results and any deviations noted during testing.
Test Case 2: Audit Trail Verification
Objective: To ensure that the Capsule Metal Detector maintains an accurate audit trail of operations.
Procedure: Review the audit trail after performing several detection tests. Confirm that all actions are logged correctly.
Acceptance Criteria: The audit trail must reflect all operations performed during the testing period.
Evidence: Printed audit trail report with timestamps and actions taken.
Deviations
Any deviations from the acceptance criteria must be documented and investigated. A root cause analysis should be performed, and corrective actions must be implemented as necessary.
Approvals
Prepared By: [Preparer Name] Date: [Date]
Reviewed By: [Reviewer Name] Date: [Date]
Approved By: [Approver Name] Date: [Date]
Data Integrity Checks
As CSV is required, ensure the following data integrity checks are performed:
- Validation of data entry during sensitivity tests.
- Regular backup of audit trail logs.
- Access controls to prevent unauthorized changes to test data.