Performance Qualification Protocol for Inline Checkweigher in Ophthalmics
Document Control:
Document Number: PQ-CHK-001
Version: 1.0
Effective Date: [Insert Date]
Review Date: [Insert Date]
Prepared By: [Insert Name]
Approved By: [Insert Name]
Objective
The objective of this Performance Qualification (PQ) protocol is to verify the functionality and accuracy of the Inline Checkweigher used in the packaging of sterile eye drops and eye ointments. This protocol ensures compliance with the acceptance criteria as outlined in the URS Annex11.
Scope
This protocol applies to the Inline Checkweigher utilized in the Packaging/Primary area for the verification of fill weight in the production of sterile ophthalmic products. The protocol addresses the critical parameters impacting the product’s quality and compliance.
Responsibilities
- Validation Team: Responsible for executing the PQ protocol and documenting results.
- Quality Assurance: Responsible for reviewing and approving the protocol and results.
- Production Team: Responsible for providing necessary access to equipment and supporting the validation process.
Prerequisites
- Completion of Installation Qualification (IQ) and Operational Qualification (OQ).
- Availability of relevant SOPs and URS documentation.
- Training of personnel on equipment operation and validation procedures.
Equipment Description
The Inline Checkweigher is a precision weighing device designed to measure the fill weight of sterile eye drops and ointments during the packaging process. The equipment features an accuracy reject logic audit trail to ensure compliance with critical quality parameters.
Test Plan
| Test ID | Procedure | Acceptance | Evidence |
|---|---|---|---|
| PQ-CHK-001 | Verify accuracy of weight measurements using calibrated weights. | All measurements within ±0.5g of target weight. | Calibration report and measurement logs. |
| PQ-CHK-002 | Audit the reject logic functionality. | Reject logic activates for out-of-spec weights. | Audit trail report. |
Detailed Test Cases
Test Case 1: Accuracy Verification
Objective: To ensure the checkweigher accurately measures the fill weight.
Procedure: Use calibrated weights to measure fill weights at different intervals. Record all measurements.
Acceptance Criteria: All measurements must be within ±0.5g of the target weight.
Evidence: Calibration report and measurement logs.
Test Case 2: Reject Logic Functionality
Objective: To verify that the reject logic functions correctly.
Procedure: Simulate out-of-spec weights and confirm that the checkweigher activates the reject logic.
Acceptance Criteria: Reject logic must activate for weights outside the acceptable range.
Evidence: Audit trail report documenting reject events.
Deviations
Any deviations from the acceptance criteria must be documented and investigated. Corrective actions should be implemented as necessary, and re-testing should occur to ensure compliance.
Approvals
Prepared By: [Insert Name] – [Insert Title]
Approved By: [Insert Name] – [Insert Title]
Date: [Insert Date]