Standard Operating Procedure for Equipment Validation of Co-Mill/Conical Mill

Purpose: This SOP outlines the validation process for the Co-Mill/Conical Mill used in the production of solid dosage forms, ensuring compliance with regulatory standards and product quality.

Scope: This procedure applies to the validation of Co-Mill/Conical Mill equipment in the Production/Milling area for de-agglomeration and sizing processes.

Definitions:

• Co-Mill/Conical Mill: Equipment used to reduce particle size and de-agglomerate materials.
• Validation: The process of proving that a system meets its intended use and specifications.
• DQ/IQ/OQ/PQ: Design Qualification, Installation Qualification, Operational Qualification, Performance Qualification.

Roles:

• Validation Team: Responsible for the execution and documentation of the validation process.
• Quality Assurance: Ensures compliance with regulatory requirements and reviews validation documentation.
• Production Personnel: Operate the equipment and provide input during validation activities.

Lifecycle Procedure:

1. Design Qualification (DQ): Assess and document equipment design specifications.
2. Installation Qualification (IQ): Verify that the equipment is installed according to manufacturer specifications.
3. Operational Qualification (OQ): Confirm that the equipment operates within predetermined limits.
4. Performance Qualification (PQ): Validate that the equipment performs effectively with actual product.

GDP Controls: Good Documentation Practices must be followed throughout the validation process, ensuring all records are accurate, complete, and maintained in a timely manner.

Acceptance Criteria Governance: Acceptance criteria will be defined in the User Requirements Specification (URS) document, ensuring that all validation results meet the specified requirements.

Calibration/PM Governance: Equipment must be calibrated and undergo preventive maintenance as per the manufacturer’s recommendations and company policies to ensure continued compliance and performance.

Change Control Triggers: Any changes to equipment, processes, or materials that may impact validation status must be evaluated and documented through the change control process.

Revalidation Triggers and Periodic Review: Revalidation is required every 24 months or whenever significant changes occur that may affect equipment performance or product quality. Periodic reviews should be conducted to assess the ongoing compliance of the equipment.

Records/Attachments List:

• Validation Protocols
• Validation Reports
• User Requirements Specification (URS)
• Calibration and Maintenance Records
• Change Control Documentation