Performance Qualification Protocol for Inline Tablet Metal Detector
Document Number: PQ-OSD-TMD-001
Version: 1.0
Effective Date: [Insert Date]
Prepared By: [Insert Name]
Reviewed By: [Insert Name]
Approved By: [Insert Name]
Objective
The objective of this Performance Qualification (PQ) protocol is to verify that the Inline Tablet Metal Detector operates within specified parameters to ensure effective detection of metal contaminants in solid dosage forms.
Scope
This protocol applies to the Inline Tablet Metal Detector used in the production area for solid dosage forms. It encompasses the validation of the equipment’s performance in detecting metal contamination directly impacting product quality.
Responsibilities
The validation team is responsible for executing the protocol, documenting results, and ensuring compliance with regulatory requirements. The Quality Assurance (QA) team will review and approve the protocol and results.
Prerequisites
- Completion of Installation Qualification (IQ) and Operational Qualification (OQ).
- Availability of necessary materials for testing.
- Training of personnel on the use of the Inline Tablet Metal Detector.
Equipment Description
The Inline Tablet Metal Detector is designed to detect metallic contaminants in tablets during the production process. It operates continuously and provides real-time feedback on product safety.
Test Plan
| Test ID | Procedure | Acceptance Criteria | Evidence |
|---|---|---|---|
| PQ-TMD-01 | Conduct sensitivity reject verification using standard metal samples. | 100% detection rate for all specified metal types. | Test results log and audit trail. |
Detailed Test Cases
Test Case 1: Sensitivity Reject Verification
- Objective: Verify the sensitivity of the metal detector.
- Procedure: Introduce standard metal samples (e.g., ferrous, non-ferrous) at specified sizes and monitor detection.
- Expected Result: The detector should reject all contaminated tablets with 100% accuracy.
- Evidence: Documented results and audit trail.
Deviations
Any deviations from the acceptance criteria must be documented, including the reason for deviation and corrective actions taken.
Approvals
The protocol must be approved by the QA team and relevant stakeholders prior to execution. All results must be reviewed and approved upon completion of the qualification activities.
Data Integrity Checks
- Ensure that all data entries are timestamped and user-identified.
- Regular audits of the data logs to confirm accuracy and completeness.
- Validation of electronic records against physical copies.