Standard Operating Procedure for Equipment Validation of Spheronizer/Marumerizer

Purpose: This SOP outlines the procedures for validating the Spheronizer/Marumerizer used in the production of solid dosage forms, ensuring compliance with regulatory standards and product quality.

Scope: This document applies to the Spheronizer/Marumerizer equipment utilized in the production area for the spheronization of pellets.

Definitions:

• Spheronization: A process used to produce spherical pellets from extrudates.
• Validation: The documented evidence that a system or process meets its intended use and complies with regulatory requirements.
• Criticality: Major – indicates significant impact on product quality.

Roles:

• Validation Team: Responsible for executing the validation activities and ensuring compliance with this SOP.
• Quality Assurance: Responsible for reviewing and approving validation documentation.
• Production Personnel: Operate the equipment and ensure adherence to procedural requirements.

Lifecycle Procedure:

1. Design Qualification (DQ): Ensure the equipment design meets user requirements.
2. Installation Qualification (IQ): Verify that the equipment is installed according to specifications.
3. Operational Qualification (OQ): Confirm that the equipment operates within defined limits.
4. Performance Qualification (PQ): Validate that the equipment performs effectively in real-world conditions.

Good Documentation Practices (GDP) Controls: All validation documents must be completed in accordance with GDP guidelines, ensuring accuracy and traceability.

Acceptance Criteria Governance: Acceptance criteria will be established based on the User Requirement Specification (URS) and must be met during each qualification phase.

Calibration/PM Governance: Regular calibration and preventive maintenance must be performed in accordance with the manufacturer’s specifications and internal procedures to ensure equipment reliability.

Change Control Triggers: Any changes to equipment, processes, or materials that may affect the validation status must be documented and evaluated 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:

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