Document Control
Document Number: DQ-OSD-CCW-001
Version: 1.0
Effective Date: [Insert Date]
Reviewed By: [Insert Name]
Approval Date: [Insert Date]
Design Qualification Protocol for Capsule Checkweigher
Meta Description: This document outlines the Design Qualification Protocol for the Capsule Checkweigher used in Solid Dosage Form production, focusing on weight verification and critical parameters.
Tags: Equipment Validation, Design Qualification, Capsule Checkweigher, OSD
Objective
The objective of this protocol is to establish the Design Qualification (DQ) for the Capsule Checkweigher, ensuring it meets specified requirements for weight verification in the production of solid dosage forms.
Scope
This protocol applies to the Capsule Checkweigher used in the Production area for the verification of capsule weights. It encompasses the validation of critical parameters and compliance with regulatory standards.
Responsibilities
- Validation Team: Responsible for executing the DQ protocol and documenting results.
- Quality Assurance: Responsible for reviewing and approving the DQ protocol and results.
- Production Personnel: Responsible for operating the Capsule Checkweigher as per the validated procedures.
Prerequisites
- Completion of User Requirements Specification (URS) as per Annex 11.
- Installation Qualification (IQ) completed.
- Operational Qualification (OQ) documentation available.
Equipment Description
The Capsule Checkweigher is an automated device used to verify the weight of capsules during the production process. It features an accuracy reject mechanism and maintains an audit trail for compliance and traceability.
Test Plan
| Test ID | Procedure | Acceptance Criteria | Evidence |
|---|---|---|---|
| T1 | Verify accuracy of the checkweigher using calibrated weights. | Weight verification must be within ±0.5% of nominal weight. | Calibration report, test records. |
| T2 | Audit the reject mechanism for functionality. | Reject mechanism must activate for weights outside acceptance criteria. | Test records, observation logs. |
| T3 | Review audit trail for data integrity. | Audit trail must show all transactions without gaps. | Audit trail report. |
Detailed Test Cases
Test Case T1: Accuracy Verification
Procedure: Use calibrated weights to test the checkweigher’s accuracy. Document the weight readings.
Expected Outcome: All readings fall within ±0.5% of the nominal weight.
Test Case T2: Reject Mechanism Functionality
Procedure: Test the reject mechanism by placing weights above and below the acceptance criteria.
Expected Outcome: The checkweigher should reject any capsules outside the acceptance criteria.
Test Case T3: Audit Trail Review
Procedure: Review the audit trail for completeness and accuracy.
Expected Outcome: The audit trail must be complete with no missing entries.
Deviations
Any deviations from the acceptance criteria must be documented and evaluated for impact on product quality. Corrective actions should be implemented as necessary.
Approvals
Validation Team Lead: ________________________ Date: ___________
Quality Assurance Manager: ________________________ Date: ___________