Document Control
Document ID: PQ-OSD-TCW-001
Version: 1.0
Effective Date: [Insert Date]
Reviewed By: [Insert Name]
Approval Date: [Insert Date]
Performance Qualification Protocol for Inline Tablet Checkweigher
Meta Description: This document outlines the Performance Qualification protocol for the Inline Tablet Checkweigher used in Solid Dosage Form production, focusing on weight verification and critical parameters.
Objective
The objective of this protocol is to verify the performance of the Inline Tablet Checkweigher to ensure it meets the specified acceptance criteria for weight verification in the Solid Dosage Form production area.
Scope
This protocol applies to the Inline Tablet Checkweigher used in the Production/Compression area for weight verification of solid dosage forms. It encompasses all critical parameters as outlined in the User Requirement Specification (URS) Annex 11.
Responsibilities
- Validation Team: Responsible for executing the PQ protocol and documenting results.
- Quality Assurance: Responsible for reviewing and approving the protocol and results.
- Production Personnel: Responsible for ensuring the equipment is maintained in a qualified state during the PQ process.
Prerequisites
- Completion of Installation Qualification (IQ) and Operational Qualification (OQ).
- Training of personnel on the operation of the Inline Tablet Checkweigher.
- Availability of necessary calibration and verification tools.
Equipment Description
The Inline Tablet Checkweigher is designed for real-time weight verification of tablets during the compression process. It features an accuracy reject mechanism and an audit trail for compliance tracking.
Test Plan
| Test ID | Procedure | Acceptance | Evidence |
|---|---|---|---|
| PQ-TCW-001 | Verify accuracy of weight measurement using calibrated weights. | Weight measurement must be within ±5% of target weight. | Calibration records, test results. |
| PQ-TCW-002 | Audit reject mechanism to ensure proper operation. | Reject mechanism must activate for out-of-spec weights. | Audit trail logs, observation records. |
Detailed Test Cases
Test Case 1: Weight Measurement Accuracy
Objective: To verify the accuracy of the Inline Tablet Checkweigher.
Procedure: Use calibrated weights to test the checkweigher at various weight points (e.g., 100mg, 200mg, 300mg).
Acceptance Criteria: All measurements must fall within ±5% of the target weight.
Data Integrity Checks: Ensure that all weight measurements are logged in a secure database and that the data is retrievable for audit purposes.
Test Case 2: Reject Mechanism Audit
Objective: To ensure the reject mechanism functions correctly.
Procedure: Introduce weights outside of the acceptable range and verify that the reject mechanism activates.
Acceptance Criteria: The checkweigher must reject all out-of-spec weights and log the event in the audit trail.
Data Integrity Checks: Review the audit trail to confirm that all reject events are documented correctly.
Deviations
Any deviations from the acceptance criteria must be documented and investigated. A root cause analysis will be performed to determine the impact on product quality.
Approvals
Prepared By: [Insert Name]
Approved By: [Insert Name]
Date: [Insert Date]