Capsule Metal Detector – IQ Protocol

Installation Qualification Protocol for Capsule Metal Detector

Document Control:

  • Document Number: IQ-OSD-001
  • Version: 1.0
  • Effective Date: [Insert Date]
  • Review Date: [Insert Date]
  • Prepared By: [Insert Name]
  • Approved By: [Insert Name]

Objective

The objective of this Installation Qualification (IQ) protocol is to verify that the Capsule Metal Detector is installed correctly and operates according to the specified requirements to ensure product safety and quality.

Scope

This protocol applies to the Capsule Metal Detector used in the production area for Solid Dosage Forms (OSD). It encompasses the installation, verification, and documentation of the equipment’s critical parameters.

Responsibilities

  • Validation Team: Responsible for executing the IQ protocol and documenting results.
  • Quality Assurance: Responsible for reviewing and approving the IQ protocol and results.
  • Maintenance Team: Responsible for the installation and maintenance of the Capsule Metal Detector.

Prerequisites

Ensure that the Capsule Metal Detector has been delivered, installed, and is ready for qualification testing. All necessary utilities and connections must be in place.

Equipment Description

The Capsule Metal Detector is designed to detect ferrous and non-ferrous metal contaminants in capsule products. It is critical for ensuring product integrity and compliance with safety regulations.

Test Plan

Test ID Procedure Acceptance Criteria Evidence
IQ-01 Verify installation according to manufacturer’s specifications. Installation meets all specifications. Installation checklist signed off.
IQ-02 Conduct sensitivity reject verification. Rejects all test metal pieces as specified. Test results log.
IQ-03 Audit trail verification. Complete and accurate audit trail is maintained. Audit trail report.
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Detailed Test Cases

Test Case 1: Installation Verification

Check that the Capsule Metal Detector is installed in accordance with the manufacturer’s guidelines. Document any discrepancies.

Test Case 2: Sensitivity Reject Verification

Test with known metal contaminants to ensure the detector rejects all specified metal types. Document the results and any failures.

Test Case 3: Audit Trail Verification

Review the equipment’s audit trail for completeness and accuracy. Ensure all entries are time-stamped and logged correctly.

Deviations

Any deviations from the acceptance criteria must be documented and assessed for impact on product quality. A CAPA (Corrective and Preventive Action) may be initiated if necessary.

Approvals

This protocol must be reviewed and approved by the Quality Assurance team before execution. Signatures below indicate approval:

  • ____________________ (Prepared By)
  • ____________________ (Approved By)

Data Integrity Checks

Ensure that the following data integrity checks are performed:

  • Automated logging of test results.
  • Regular backups of audit trails.
  • Access controls to prevent unauthorized modifications.

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