Performance Qualification Protocol for Loss-in-Weight Feeder
Document Control:
Document Number: PQ-LIW-001
Version: 1.0
Effective Date: YYYY-MM-DD
Reviewed By: [Reviewer Name]
Approved By: [Approver Name]
Objective
The objective of this Performance Qualification (PQ) protocol is to ensure that the Loss-in-Weight Feeder operates within specified parameters to achieve accurate powder feeding during the production of solid dosage forms.
Scope
This protocol applies to the Loss-in-Weight Feeder utilized in the production area of continuous manufacturing for solid dosage forms. It encompasses the activities involved in validating the performance of the equipment to ensure compliance with the User Requirements Specification (URS) and regulatory guidelines.
Responsibilities
The Validation Team is responsible for executing this protocol, documenting results, and ensuring compliance with the acceptance criteria. The Quality Assurance department will review and approve the protocol and results.
Prerequisites
- Completion of Installation Qualification (IQ) and Operational Qualification (OQ).
- Training of personnel on the operation of the Loss-in-Weight Feeder.
- Availability of necessary materials for testing.
Equipment Description
The Loss-in-Weight Feeder is designed for precise powder feeding in continuous manufacturing processes. It employs a feed accuracy control loop to maintain specified feed rates, ensuring the direct impact on product quality.
Test Plan
| Test ID | Procedure | Acceptance | Evidence |
|---|---|---|---|
| PQ-LIW-001 | Verify feed accuracy control loop alarms | Alarms trigger within specified limits | Alarm log report |
Detailed Test Cases
Test Case 1: Verify Feed Accuracy Control Loop Alarms
Objective: To ensure that the alarms for feed accuracy are functioning properly.
Procedure: Initiate the feeder and monitor the feed accuracy control loop. Adjust the feed rate to trigger alarms.
Acceptance Criteria: Alarms must activate when feed accuracy deviates from the established limits.
Expected Results: Alarm log should show activation within the specified parameters.
Deviations
Any deviations from the established acceptance criteria must be documented and assessed for impact on product quality. Corrective actions must be implemented as necessary.
Approvals
Approved by: [Approver Name] on YYYY-MM-DD
Reviewed by: [Reviewer Name] on YYYY-MM-DD
CSV Requirements
Data integrity checks will include:
- Verification of data logging for feed rates.
- Audit trails for alarm triggers and responses.
- Regular backups of operational data.