Document Number: DQ-OSD-TCW-001
Revision: 1.0
Date: [Insert Date]
Prepared by: [Insert Name]
Approved by: [Insert Name]
Design Qualification Protocol for Inline Tablet Checkweigher
Meta Description: This document outlines the Design Qualification Protocol for the Inline Tablet Checkweigher used in Solid Dosage Form production, ensuring compliance with critical acceptance criteria.
Tags: Equipment Validation, Design Qualification, Tablet Checkweigher, Solid Dosage Form
Objective
The objective of this Design Qualification (DQ) protocol is to verify that the Inline Tablet Checkweigher is suitable for its intended use in the production of solid dosage forms, specifically for weight verification, and to ensure compliance with regulatory requirements.
Scope
This protocol applies to the Inline Tablet Checkweigher used in the production/compression area for direct product impact with criticality classified as critical.
Responsibilities
The Validation Team is responsible for the execution of this protocol, while Quality Assurance (QA) is responsible for the review and approval of the documentation.
Prerequisites
- Installation Qualification (IQ) must be completed.
- Operational Qualification (OQ) must be completed.
- Staff training on the use of the equipment must be conducted.
Equipment Description
The Inline Tablet Checkweigher is designed to verify the weight of tablets during the production process. It features an accuracy reject mechanism and maintains an audit trail for compliance with regulatory standards.
Test Plan
| Test ID | Procedure | Acceptance | Evidence |
|---|---|---|---|
| T1 | Verify accuracy of weight measurement | Weight within ±5% of target | Calibration report, measurement logs |
| T2 | Audit trail verification | Complete audit trail for all measurements | Audit trail report |
| T3 | Test reject mechanism functionality | Rejects out-of-spec weight | Test logs, observation records |
Detailed Test Cases
Test Case T1: Verify Accuracy of Weight Measurement
Procedure: Measure the weight of standard tablets using the checkweigher and compare with the target weight.
Acceptance Criteria: The weight must be within ±5% of the target weight.
Evidence: Calibration report and measurement logs will be recorded.
Test Case T2: Audit Trail Verification
Procedure: Review the audit trail for all weight measurements taken during production.
Acceptance Criteria: The audit trail must be complete and traceable.
Evidence: Audit trail report will be generated and reviewed.
Test Case T3: Test Reject Mechanism Functionality
Procedure: Simulate out-of-spec weight and verify the reject mechanism activates.
Acceptance Criteria: The system must reject any out-of-spec weight.
Evidence: Test logs and observation records will be documented.
Deviations
Any deviations from the acceptance criteria must be documented and investigated. A corrective action plan will be developed as necessary.
Approvals
Prepared by: ___________________________ Date: _______________
Approved by: ___________________________ Date: _______________
Data Integrity Checks
- Ensure that all data entries are timestamped and user-identified.
- Conduct periodic audits of the checkweigher’s audit trail to ensure no data manipulation.
- Verify that all data is backed up and securely stored.