Operational Qualification Protocol for Analytical Weighing Balance in Solid Dosage Form
Document Number: OQ-001
Version: 1.0
Effective Date: 2023-10-01
Reviewed By: [Name]
Approved By: [Name]
Objective
The objective of this Operational Qualification (OQ) protocol is to verify that the Analytical Weighing Balance operates according to its intended use and meets the specified acceptance criteria.
Scope
This protocol applies to the Operational Qualification of the Analytical Weighing Balance used in the Production/Dispensing area for weighing raw materials and in-process controls (IPC) in the Solid Dosage Form (OSD) manufacturing process.
Responsibilities
- Validation Team: Execute the OQ protocol and document results.
- Quality Assurance: Review and approve the OQ protocol and results.
- Equipment Owner: Ensure the equipment is available and in proper working condition.
Prerequisites
- Equipment must be installed and calibrated as per URS SOP Calibration.
- Personnel must be trained on the use of the Analytical Weighing Balance.
Equipment Description
The Analytical Weighing Balance is designed for precise weighing of raw materials and in-process controls, providing high accuracy and repeatability in measurements critical to the OSD manufacturing process.
Test Plan
| Test ID | Procedure | Acceptance Criteria | Evidence |
|---|---|---|---|
| OQ-01 | Verify accuracy using calibrated weights. | Accuracy within ±0.01g. | Calibration report. |
| OQ-02 | Test repeatability by weighing the same sample multiple times. | Standard deviation ≤ 0.005g. | Weighing log. |
| OQ-03 | Verify linearity across the weighing range. | Linearity error < 0.02g. | Linearity test report. |
Detailed Test Cases
Test Case OQ-01: Accuracy Verification
Procedure: Using calibrated weights, perform a series of weighings.
Acceptance Criteria: Accuracy within ±0.01g.
Evidence: Document results in the calibration report.
Test Case OQ-02: Repeatability Testing
Procedure: Weigh the same sample five times and calculate the standard deviation.
Acceptance Criteria: Standard deviation ≤ 0.005g.
Evidence: Record results in the weighing log.
Test Case OQ-03: Linearity Verification
Procedure: Weigh a range of calibrated weights from minimum to maximum capacity.
Acceptance Criteria: Linearity error < 0.02g.
Evidence: Document results in the linearity test report.
Deviations
Any deviations from the established acceptance criteria must be documented and investigated. A root cause analysis should be performed, and corrective actions should be implemented as necessary.
Approvals
Validation Team Lead: ______________________ Date: ___________
Quality Assurance Manager: ______________________ Date: ___________
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