Standard Operating Procedure for the Validation of Oscillating Granulator Equipment

Purpose: This SOP outlines the validation process for the Oscillating Granulator used in the production of solid dosage forms, ensuring compliance with regulatory requirements and operational standards.

Scope: This procedure applies to the validation of the Oscillating Granulator in the Production/Milling area, encompassing all phases of the equipment lifecycle including Design Qualification (DQ), Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ).

Definitions:

• Oscillating Granulator: A piece of equipment used for size reduction of wet/dry mass in the production of solid dosage forms.
• Validation: The process of demonstrating that a procedure, process, or activity will consistently lead to the expected results.
• URS: User Requirement Specification, outlining the essential requirements for the equipment.

Roles:

• Validation Team: Responsible for executing and documenting the validation process.
• Quality Assurance: Ensures compliance with regulatory requirements and reviews validation documentation.
• Production Personnel: Operate the equipment and provide feedback during the validation process.

Lifecycle Procedure:

1. Prepare User Requirement Specification (URS).
2. Conduct Design Qualification (DQ) to ensure design meets URS.
3. Perform Installation Qualification (IQ) to verify proper installation.
4. Execute Operational Qualification (OQ) to confirm equipment operates according to specifications.
5. Complete Performance Qualification (PQ) to demonstrate equipment produces acceptable product quality.

GDP Controls: Good Documentation Practices (GDP) must be adhered to throughout the validation process, ensuring all records are accurate, complete, and traceable.

Acceptance Criteria Governance: Acceptance criteria will be established based on the URS and must be met during OQ and PQ phases.

Calibration/PM Governance: The Oscillating Granulator will undergo routine calibration and preventive maintenance as per the manufacturer’s guidelines and internal protocols.

Change Control Triggers: Any modifications to the equipment, process, or materials that may affect the validation status must be assessed through the Change Control process.

Revalidation Triggers and Periodic Review: Revalidation is required every 24 months or when significant changes occur that may impact equipment performance or product quality.

Records/Attachments List:

• User Requirement Specification (URS)
• Validation Protocols (DQ, IQ, OQ, PQ)
• Validation Summary Report
• Calibration and Maintenance Records
• Change Control Documentation