Performance Qualification Protocol for Weighing Balance in Solid Dosage Form

This document outlines the Performance Qualification (PQ) protocol for the Weighing Balance used in Solid Dosage Form production, ensuring compliance with critical parameters.

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

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