Loss-in-Weight Feeder – IQ Protocol

Installation Qualification Protocol for Loss-in-Weight Feeder

Document Number: IQ-001

Version: 1.0

Effective Date: 2023-10-01

Reviewed By: [Name]

Approval Date: [Date]

Objective

The objective of this Installation Qualification (IQ) protocol is to establish and document that the Loss-in-Weight Feeder is installed correctly and functions according to its intended use in the production of solid dosage forms.

Scope

This protocol applies to the Loss-in-Weight Feeder used in the Continuous Manufacturing area for accurate powder feeding, impacting product quality directly.

Responsibilities

The Validation Team is responsible for executing the IQ protocol, while the Quality Assurance team will review and approve the documentation.

Prerequisites

  • Installation of the Loss-in-Weight Feeder must be completed.
  • All safety checks and operational training must be conducted.
  • Relevant SOPs must be reviewed and understood.

Equipment Description

The Loss-in-Weight Feeder is designed for precise and continuous feeding of powders in solid dosage form manufacturing. It features a feed accuracy control loop with alarms for critical parameters.

Test Plan

Test ID Procedure Acceptance Criteria Evidence
IQ-01 Verify installation against manufacturer’s specifications. All components installed as per specifications. Installation checklist signed off.
IQ-02 Check feed accuracy control loop functionality. Control loop alarms function as intended. Alarm test results documented.
IQ-03 Conduct a data integrity check. Data integrity checks pass without discrepancies. Data integrity report.

Detailed Test Cases

Test Case: IQ-01

Verify installation against manufacturer’s specifications.

  • Check that all components are present and installed correctly.
  • Review installation manual for compliance.
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Test Case: IQ-02

Check feed accuracy control loop functionality.

  • Simulate feed conditions to trigger alarms.
  • Document alarm responses and functionality.

Test Case: IQ-03

Conduct a data integrity check.

  • Verify that data logging is functioning correctly.
  • Check that historical data is retrievable and accurate.

Deviations

Any deviations from the acceptance criteria must be documented and investigated. A corrective action plan should be developed for any identified issues.

Approvals

Approved by: [Name]
Title: [Title]
Date: [Date]

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