Top Pan Balance – DQ Protocol

Document ID: DQ-QC-TPB-001

Version: 1.0

Effective Date: 2023-10-01

Reviewed By: [Name]

Approval Date: [Date]

Design Qualification Protocol for Top Pan Balance in QC Laboratory

Meta Description: This document outlines the Design Qualification (DQ) protocol for the Top Pan Balance used in the QC Laboratory for weighing bulk samples, ensuring compliance with critical parameters.

Tags: Equipment Validation, QC Laboratory, Top Pan Balance, Design Qualification

Objective

The objective of this Design Qualification (DQ) protocol is to ensure that the Top Pan Balance used in the QC Laboratory meets the specified requirements for weighing bulk samples, focusing on accuracy and repeatability.

Scope

This protocol applies to the Top Pan Balance located in the QC Lab, which is utilized for weighing bulk samples that directly impact product quality.

Responsibilities

  • Validation Team: Responsible for executing and documenting the DQ protocol.
  • Quality Assurance: Responsible for reviewing and approving the DQ protocol.
  • Laboratory Personnel: Responsible for operating the Top Pan Balance in accordance with established procedures.

Prerequisites

  • Completion of installation and operational qualification (IQ/OQ).
  • Availability of relevant standard operating procedures (SOPs) for the Top Pan Balance.
  • Personnel trained in the operation of the Top Pan Balance.

Equipment Description

The Top Pan Balance is an instrument used for weighing bulk samples in the QC Laboratory. It is designed to provide accurate measurements with a specified capacity and readability suitable for laboratory use.

See also  Cryo/Cold Storage (2–8°C / -20°C / -80°C) – Validation Summary Report (VSR) Template

Test Plan

Test ID Procedure Acceptance Evidence
DQ-TPB-01 Verify accuracy using calibrated weights. Accuracy within ±0.01g. Calibration report.
DQ-TPB-02 Conduct repeatability tests with multiple weighings. Standard deviation ≤ 0.005g. Test results summary.

Detailed Test Cases

Test Case 1: Accuracy Verification

Procedure: Place calibrated weights on the balance and record the displayed weight. Repeat for at least five different weights.

Acceptance Criteria: The displayed weight must be within ±0.01g of the actual weight.

Evidence: Calibration report and recorded weights.

Test Case 2: Repeatability Testing

Procedure: Weigh the same bulk sample five times consecutively and record the results.

Acceptance Criteria: The standard deviation of the recorded weights must not exceed 0.005g.

Evidence: Summary of recorded weights and statistical analysis.

Deviations

Any deviations from the acceptance criteria must be documented, including the reason for the deviation and corrective actions taken.

Approvals

This protocol must be reviewed and approved by the Quality Assurance department prior to execution.

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