Equipment Validation SOP for Single Screw Extruder in Solid Dosage Form

Purpose: This Standard Operating Procedure (SOP) outlines the validation process for the Single Screw Extruder used in the production of pellets, ensuring compliance with regulatory requirements and product quality standards.

Scope: This SOP applies to the validation of the Single Screw Extruder located in the Production area for the manufacture of solid dosage forms (OSD), specifically pellets.

Definitions:

• DQ: Design Qualification
• IQ: Installation Qualification
• OQ: Operational Qualification
• PQ: Performance Qualification
• CSV: Computer System Validation

Roles:

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

Lifecycle Procedure:

1. Conduct Design Qualification (DQ) to ensure the equipment meets user requirements.
2. Perform Installation Qualification (IQ) to verify that the equipment is installed correctly and according to specifications.
3. Execute Operational Qualification (OQ) to confirm that the equipment operates within specified limits.
4. Carry out Performance Qualification (PQ) to demonstrate that the equipment consistently produces quality pellets.

GDP Controls: Good Documentation Practices (GDP) must be followed throughout the validation process, ensuring all records are accurate, complete, and readily available for review.

Acceptance Criteria Governance: Acceptance criteria will be established based on User Requirements Specification (URS) and Annex 11 guidelines, ensuring that all validation activities meet predefined standards.

Calibration/PM Governance: The Single Screw Extruder must undergo regular calibration and preventive maintenance as per the established schedule to ensure continued compliance and performance.

Change Control Triggers: Any changes to the equipment, process, or associated systems must be evaluated through the Change Control process to determine the impact on validation status.

Revalidation Triggers and Periodic Review: Revalidation is required every 24 months or upon significant changes to the equipment, processes, or if deviations occur that affect product quality.

Records/Attachments List:

• Validation Protocols (DQ, IQ, OQ, PQ)
• Calibration Records
• Preventive Maintenance Logs
• Change Control Documentation
• Periodic Review Reports