Equipment Validation Procedure for Flake Crusher in Solid Dosage Form

Purpose

This SOP outlines the validation process for the Flake Crusher used in the production of solid dosage forms, ensuring compliance with regulatory standards and operational efficiency.

Scope

This procedure applies to the Flake Crusher utilized in the Production/Dry Granulation area, focusing on its use to crush ribbons/flakes for solid dosage forms.

Definitions

• Flake Crusher: Equipment used to crush ribbons/flakes post-roller compaction.
• Validation: A documented process demonstrating that a system meets its intended use.
• URS: User Requirement Specification.

Roles

• Validation Team: Responsible for the execution and documentation of validation activities.
• Quality Assurance: Ensures compliance with SOPs and regulatory requirements.
• Production Personnel: Operate the Flake Crusher and maintain equipment records.

Lifecycle Procedure

1. Design Qualification (DQ): Verify that the Flake Crusher design meets user requirements.
2. Installation Qualification (IQ): Confirm that the equipment is installed correctly and in accordance with specifications.
3. Operational Qualification (OQ): Validate that the Flake Crusher operates according to its intended purpose.
4. Performance Qualification (PQ): Demonstrate that the equipment consistently performs as expected in a production environment.

Good Documentation Practices (GDP) Controls

All validation activities must be documented accurately, with clear records maintained for each phase of the validation lifecycle. Documentation should include signed approvals from all relevant parties.

Acceptance Criteria Governance (URS)

The Flake Crusher must meet the specifications outlined in the User Requirement Specification (URS) to ensure product impact is direct and criticality is major.

Calibration/PM Governance

The Flake Crusher must undergo regular calibration and preventive maintenance as per the established schedule to maintain operational integrity.

Change Control Triggers

Any changes to the Flake Crusher or its operating procedures must initiate a change control process, including but not limited to modifications, upgrades, or repairs that could impact equipment performance.

Revalidation Triggers and Periodic Review

The Flake Crusher will undergo revalidation every 24 months or whenever significant changes occur that may affect its performance.

Records/Attachments List

• Validation Protocols
• Validation Reports
• Calibration Records
• Maintenance Logs
• Change Control Documentation