Document Number: DQ-OSD-LIW-001
Version: 1.0
Date: 2023-10-01
Prepared by: Validation Team
Approved by: QA Manager
Design Qualification Protocol for Loss-in-Weight Feeder
This document outlines the Design Qualification (DQ) protocol for the Loss-in-Weight Feeder used in the production of solid dosage forms.
Objective:
The objective of this DQ protocol is to ensure that the Loss-in-Weight Feeder is designed and installed in accordance with specified requirements and is suitable for its intended use in accurate powder feeding.
Scope:
This protocol applies to the Loss-in-Weight Feeder utilized in the production/continuous manufacturing area for solid dosage forms where it has a direct impact on product quality.
Responsibilities:
- Validation Team: Responsible for executing the DQ protocol and documenting results.
- Quality Assurance (QA): Responsible for reviewing and approving the DQ protocol and results.
- Engineering: Responsible for providing technical specifications and support during the qualification process.
Prerequisites:
- Completion of User Requirement Specification (URS) as per Annex 11.
- Availability of equipment installation and operation manuals.
- Training of personnel involved in the validation process.
Equipment Description:
The Loss-in-Weight Feeder is designed for accurate powder feeding in continuous manufacturing processes. It utilizes a feed accuracy control loop with alarms to ensure precision in material delivery.
| Test ID | Procedure | Acceptance Criteria | Evidence |
|---|---|---|---|
| DQ-001 | Verify installation against engineering specifications. | All components installed as per specifications. | Installation checklist signed off. |
| DQ-002 | Check feed accuracy control loop alarms functionality. | Alarms trigger within specified limits. | Alarm test log. |
| DQ-003 | Perform data integrity checks on CSV. | Data integrity checks pass without errors. | Data integrity report. |
Detailed Test Cases:
- Test Case ID: DQ-001
- Test Case ID: DQ-002
- Test Case ID: DQ-003
Test Description: Verify installation against engineering specifications.
Expected Result: All components installed as per specifications.
Test Description: Check feed accuracy control loop alarms functionality.
Expected Result: Alarms trigger within specified limits.
Test Description: Perform data integrity checks on CSV.
Expected Result: Data integrity checks pass without errors.
Deviations:
Any deviations from the acceptance criteria must be documented and assessed for impact on product quality.
Approvals:
___________________________
Validation Team Lead
___________________________
Quality Assurance Manager