Document Number: OQ-001
Version: 1.0
Effective Date: YYYY-MM-DD
Review Date: YYYY-MM-DD
Prepared by: [Name]
Approved by: [Name]
Operational Qualification Protocol for Weighing Balance in Solid Dosage Form
Objective: This protocol outlines the operational qualification (OQ) for the weighing balance used in the production and dispensing of solid dosage forms, ensuring compliance with the established acceptance criteria.
Scope: This OQ protocol applies to the weighing balance (platform/floor type) utilized in the production/dispensing area for weighing raw materials and intermediate bulk containers (IBCs) that have a direct impact on product quality.
Responsibilities:
- Validation Team: Prepare and execute the OQ protocol.
- Quality Assurance: Review and approve the protocol and results.
- Production Staff: Assist in the execution of the protocol.
Prerequisites:
- Installation Qualification (IQ) completed.
- Standard Operating Procedures (SOP) for use and calibration of the weighing balance available.
Equipment Description:
The weighing balance is a platform/floor instrument designed for accurate measurement of raw materials and IBCs in the production area. The balance must meet the accuracy and linearity requirements outlined in the user requirement specifications (URS) and SOP for calibration.
| Test ID | Procedure | Acceptance Criteria | Evidence |
|---|---|---|---|
| OQ-001-A | Perform accuracy test using calibrated weights. | Accuracy within ±0.1g of the true value. | Test results log. |
| OQ-001-B | Conduct linearity corner test. | Linearity within specified range. | Linearity test report. |
Detailed Test Cases:
- Test Case OQ-001-A:
Weigh calibrated weights of known values on the balance to verify accuracy. Record the measured values and compare with the true values.
- Test Case OQ-001-B:
Perform a linearity test by weighing multiple weights across the operational range of the balance. Document the results and ensure they fall within the acceptance criteria.
Deviations:
Any deviations from the acceptance criteria must be documented and investigated. A root cause analysis should be performed, and corrective actions should be implemented as necessary.
Approvals:
Prepared by: ______________________ Date: ___________
Approved by: ______________________ Date: ___________