Document Control
Document Number: PQ-OSD-CC-001
Version: 1.0
Effective Date: [Enter Date]
Review Date: [Enter Date]
Prepared By: [Enter Name]
Approved By: [Enter Name]
Performance Qualification Protocol for Capsule Checkweigher
Meta Description: A detailed PQ protocol for the Capsule Checkweigher focusing on weight verification in Solid Dosage Form production.
Objective
The objective of this Performance Qualification (PQ) protocol is to validate the Capsule Checkweigher used in the production of solid dosage forms, ensuring it meets the specified requirements for weight verification.
Scope
This protocol applies to the Capsule Checkweigher located in the Production/Capsules area and is intended for direct impact on product quality.
Responsibilities
The following personnel are responsible for executing this protocol:
- Validation Team: Execute the PQ tests and document results.
- Quality Assurance: Review and approve the protocol and results.
- Production Personnel: Ensure the equipment is set up and operational prior to testing.
Prerequisites
- Completion of Installation Qualification (IQ) and Operational Qualification (OQ).
- Equipment calibration records available.
- Training records for personnel operating the equipment.
Equipment Description
The Capsule Checkweigher is designed for weight verification of capsules during the production process. It features an accuracy reject mechanism and maintains an audit trail for all operations.
Test Plan
| Test ID | Procedure | Acceptance Criteria | Evidence |
|---|---|---|---|
| PQ-01 | Verify accuracy against calibrated weights. | Weight deviation must be within ±0.5 mg. | Calibration report and test results. |
| PQ-02 | Audit reject mechanism functionality. | Reject mechanism must activate for weights outside acceptance criteria. | Test results and audit trail report. |
Detailed Test Cases
Test Case 1: Accuracy Verification
Using calibrated weights, conduct a series of tests to verify the accuracy of the Capsule Checkweigher. Record the weight readings and compare them against the known values.
Test Case 2: Reject Mechanism Audit
Test the reject mechanism by placing weights outside the acceptance criteria on the checkweigher. Confirm that the mechanism activates and records the event in the audit trail.
Deviations
Any deviations from the acceptance criteria must be documented and assessed for impact on product quality. A root cause analysis should be performed for any significant deviations.
Approvals
By signing below, the following personnel approve this Performance Qualification protocol:
___________________________ Prepared By
___________________________ Reviewed By
___________________________ Approved By
Data Integrity Checks
Ensure that all data generated during the PQ process is securely stored and backed up. Implement checks to confirm that data cannot be altered post-entry without proper authorization.