Document ID: PQ-OSD-001
Version: 1.0
Effective Date: 2023-10-01
Review Date: 2024-10-01
Performance Qualification Protocol for Weighing Balance in Solid Dosage Form
Tags: Equipment Validation, Performance Qualification, Weighing Balance, Solid Dosage Form
Objective
The objective of this Performance Qualification (PQ) protocol is to validate the weighing balance’s performance in the production and dispensing of solid dosage forms, ensuring it meets the specified acceptance criteria for accuracy and linearity.
Scope
This protocol applies to the weighing balance used in the production area for weighing raw materials (RMs) and intermediate bulk containers (IBCs) within the solid dosage form manufacturing process.
Responsibilities
- Validation Team: Responsible for executing the PQ protocol and documenting results.
- Quality Assurance: Responsible for reviewing and approving the PQ protocol and results.
- Production Personnel: Responsible for ensuring the equipment is calibrated and maintained according to SOPs.
Prerequisites
- Calibration of the weighing balance must be performed as per URS SOP Calibration.
- All personnel involved must be trained on the use of the weighing balance and this PQ protocol.
Equipment Description
The weighing balance is a platform/floor instrument used for accurately weighing raw materials and intermediate bulk containers in the production area. It is critical for ensuring proper dosing in the solid dosage form manufacturing process.
Test Plan
| Test ID | Procedure | Acceptance | Evidence |
|---|---|---|---|
| TP-001 | Perform accuracy check using calibrated weights. | Accuracy within ±0.1g. | Calibration report and test results. |
| TP-002 | Conduct linearity corner test with multiple weights. | Linearity deviation within ±0.2g across range. | Linearity test report. |
Detailed Test Cases
Test Case 1: Accuracy Check
Test ID: TP-001
Procedure: Utilize calibrated weights of 1g, 5g, 10g, and 20g to check the accuracy of the balance.
Acceptance Criteria: Accuracy must be within ±0.1g of the actual weight.
Evidence: Documented results of the accuracy checks and calibration report.
Test Case 2: Linearity Corner Test
Test ID: TP-002
Procedure: Weigh calibrated weights at the low, mid, and high ends of the balance’s capacity.
Acceptance Criteria: Linearity deviation must be within ±0.2g across the range.
Evidence: Documented results of the linearity tests.
Deviations
Any deviations from the acceptance criteria must be documented and investigated. A root cause analysis should be performed, and corrective actions must be implemented and verified.
Approvals
Prepared by: [Name], Validation Team
Reviewed by: [Name], Quality Assurance
Approved by: [Name], Department Head