Equipment Validation Procedure for Air Classifier Mill

Purpose: This SOP outlines the validation process for the Air Classifier Mill used in the production of solid dosage forms, ensuring compliance with regulatory requirements and quality standards.

Scope: This procedure applies to the validation of the Air Classifier Mill located in the production/milling area for controlled fine milling processes.

Definitions:

• Equipment Validation: The process of ensuring that equipment operates according to its intended use and meets specified requirements.
• Criticality: The significance of the equipment’s impact on product quality and safety.
• DQ/IQ/OQ/PQ: Design Qualification, Installation Qualification, Operational Qualification, Performance Qualification.

Roles:

• Validation Team: Responsible for executing the validation protocol and documenting results.
• Quality Assurance: Ensures compliance with regulatory standards and oversees validation activities.
• Production Personnel: Operate the equipment and provide operational input during validation.

Lifecycle Procedure:

1. Design Qualification (DQ): Review design specifications and user requirements.
2. Installation Qualification (IQ): Verify installation against specifications and ensure proper setup.
3. Operational Qualification (OQ): Test equipment under normal operating conditions to ensure it meets performance criteria.
4. Performance Qualification (PQ): Validate the equipment’s performance with actual product under defined conditions.

GDP Controls: Good Documentation Practices must be followed throughout the validation process, ensuring all records are complete, accurate, and legible.

Acceptance Criteria Governance: Acceptance criteria will be defined in the User Requirements Specification (URS) and must be met for each qualification phase.

Calibration/PM Governance: The Air Classifier Mill must undergo regular calibration and preventive maintenance as per established schedules to maintain operational integrity.

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

Revalidation Triggers and Periodic Review: Revalidation is required every 24 months or upon significant changes to equipment or processes. A periodic review of validation documentation will be conducted to ensure ongoing compliance.

Records/Attachments List:

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