Design Qualification Protocol for Analytical Weighing Balance in Solid Dosage Form
Document Number: DQ-OSD-001
Version: 1.0
Effective Date: 2023-10-01
Review Date: 2024-10-01
Prepared by: [Your Name]
Approved by: [Approver’s Name]
Objective
The objective of this Design Qualification (DQ) protocol is to ensure that the Analytical Weighing Balance is suitable for its intended use in weighing raw materials and in-process controls, fulfilling the requirements outlined in the User Requirement Specification (URS).
Scope
This protocol applies to the Analytical Weighing Balance used in the Production/Dispensing area for Solid Dosage Form (OSD) manufacturing processes.
Responsibilities
- Validation Team: Responsible for executing the DQ protocol and documenting results.
- Quality Assurance: Responsible for reviewing and approving the DQ protocol and results.
- Maintenance Team: Responsible for ensuring the balance is calibrated and maintained according to SOPs.
Prerequisites
All personnel involved in the DQ process must be trained in validation principles and procedures. The Analytical Weighing Balance must be installed and operational prior to conducting this DQ.
Equipment Description
The Analytical Weighing Balance is designed for precise measurement of small quantities of materials in a controlled environment. Key features include:
- Capacity: [Insert Capacity]
- Readability: [Insert Readability]
- Calibration: Automated calibration feature
Test Plan
| Test ID | Procedure | Acceptance Criteria | Evidence |
|---|---|---|---|
| T1 | Verify accuracy using calibrated weights | Accuracy within ±0.1g | Calibration Report |
| T2 | Assess repeatability with multiple weighings | Standard deviation ≤ 0.05g | Test Results |
| T3 | Evaluate linearity across range | Linearity within specified limits | Linearity Report |
Detailed Test Cases
Test Case 1: Accuracy Verification
Procedure: Use calibrated weights to verify the accuracy of the balance. Record the weight displayed and compare it to the known weight.
Acceptance Criteria: Accuracy within ±0.1g.
Evidence: Calibration Report to be attached.
Test Case 2: Repeatability Assessment
Procedure: Weigh the same sample multiple times (at least 10 times) and record the results.
Acceptance Criteria: Standard deviation ≤ 0.05g.
Evidence: Test Results to be attached.
Test Case 3: Linearity Evaluation
Procedure: Weigh a series of known weights across the balance’s range and plot the results.
Acceptance Criteria: Linearity within specified limits.
Evidence: Linearity Report to be attached.
Deviations
Any deviations from the acceptance criteria must be documented and justified. A corrective action plan should be initiated for any critical deviations identified during testing.
Approvals
The completion of this protocol requires the following approvals:
- Validation Team Lead: ______________________ Date: __________
- Quality Assurance Manager: ______________________ Date: __________