Performance Qualification Protocol for Analytical Weighing Balance in Solid Dosage Form

Objective

The objective of this Performance Qualification (PQ) protocol is to verify that the Analytical Weighing Balance meets the specified performance criteria for weighing raw materials and in-process controls in the production of solid dosage forms.

Scope

This protocol applies to the Analytical Weighing Balance used in the Production/Dispensing area for weighing raw materials and in-process controls. It covers the validation of critical parameters including accuracy, repeatability, and linearity.

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: Responsible for providing access to the equipment and necessary materials for testing.

Prerequisites

Ensure that the Analytical Weighing Balance is calibrated according to the URS SOP Calibration prior to the execution of this protocol.

Equipment Description

The Analytical Weighing Balance is designed to provide precision weighing capabilities for raw materials and in-process controls in the production of solid dosage forms. It operates with a minimum sensitivity of 0.1 mg and is equipped with a draft shield to minimize environmental interference.

Test Plan

Detailed Test Cases

Test ID: PQ-01

Procedure: Verify accuracy using certified weights.

Execution: Weigh certified weights of known values (e.g., 100g, 200g, 500g) and record the measured values.

Acceptance Criteria: Results must be within ±0.5% of the certified weight.

Evidence: Calibration report and weight data.

Test ID: PQ-02

Procedure: Assess repeatability by weighing the same sample multiple times.

Execution: Weigh the same sample (e.g., 100g) ten times in succession and record each measurement.

Acceptance Criteria: Standard deviation ≤0.2 mg.

Evidence: Weighing data and statistical analysis.

Test ID: PQ-03

Procedure: Test linearity by weighing a range of certified weights.

Execution: Weigh certified weights at intervals (e.g., 50g, 100g, 150g, etc.) and record the measurements.

Acceptance Criteria: Linearity error ≤0.5% across the range.

Evidence: Linearity report and graph.

Deviations

Any deviations from the acceptance criteria must be documented and investigated, with appropriate corrective actions taken and approved by Quality Assurance.

Approvals

Prepared by: [Name] – [Title]

Approved by: [Name] – [Title]

“`