Document Control
Document Number: PQ-CHK-001
Version: 1.0
Effective Date: [Insert Date]
Reviewed By: [Insert Name]
Approval Date: [Insert Date]
Performance Qualification Protocol for Checkweigher in Packaging of Suppositories & Implants
Meta Description: This document outlines the Performance Qualification (PQ) protocol for the Checkweigher used in the packaging of suppositories and implants, focusing on weight accuracy and critical parameters.
Tags: Equipment Validation, Performance Qualification, Checkweigher, Suppositories, Implants
Objective
The objective of this Performance Qualification (PQ) protocol is to verify the weight accuracy of the Checkweigher used in the packaging process of suppositories and implants, ensuring compliance with regulatory requirements and product specifications.
Scope
This protocol applies to the Checkweigher located in the packaging area for suppositories and implants. It encompasses all activities related to the verification of weight accuracy and related critical parameters.
Responsibilities
The following personnel are responsible for the execution of this protocol:
- Validation Engineer: Execute the protocol and document results.
- Quality Assurance: Review and approve the protocol.
- Production Supervisor: Ensure that the equipment is available and operational.
Prerequisites
- Checkweigher must be calibrated and maintained according to standard operating procedures.
- All personnel involved must be trained on the equipment and validation procedures.
- Necessary materials for testing must be available (e.g., test weights).
Equipment Description
The Checkweigher is an automated device used to verify the weight of suppositories during the packaging process. It features an integrated reject logic system and maintains an audit trail log for compliance and traceability.
Test Plan
| Test ID | Procedure | Acceptance Criteria | Evidence |
|---|---|---|---|
| PQ-CHK-001 | Verify weight accuracy using calibrated test weights. | Weight must be within ±0.5 grams of target weight. | Calibration log, test weight records. |
| PQ-CHK-002 | Check reject logic functionality. | Reject logic activates for weights outside acceptance criteria. | Audit trail log, test results. |
| PQ-CHK-003 | Review audit trail logs for accuracy. | Logs must show no discrepancies for the test period. | Audit trail log review report. |
Detailed Test Cases
Test Case 1: Weight Accuracy Verification
1. Calibrate the Checkweigher using certified test weights.
2. Record the weight displayed on the Checkweigher for each test weight.
3. Compare the displayed weight against the known weight.
4. Document the results and ensure all weights are within ±0.5 grams of the target weight.
Test Case 2: Reject Logic Functionality
1. Prepare test weights that are above and below the acceptance criteria.
2. Run the Checkweigher with these weights.
3. Confirm that the Checkweigher correctly rejects weights outside of the acceptance criteria.
4. Document the results and ensure that the reject logic operates as intended.
Test Case 3: Audit Trail Log Review
1. Access the Checkweigher’s audit trail logs.
2. Review logs for the testing period to ensure no discrepancies or errors.
3. Document findings and ensure compliance with data integrity standards.
Deviations
Any deviations from the protocol must be documented and assessed for impact on product quality. A root cause analysis should be performed, and corrective actions must be implemented as necessary.
Approvals
____________________
Validation Engineer
Date: ________________
____________________
Quality Assurance
Date: ________________