Standard Operating Procedure for Equipment Validation of Aseptic Filling for Long-Acting Injectables

Purpose: This SOP outlines the validation process for Aseptic Filling equipment used in the production of Long-Acting Injectables (Depot Suspensions) to ensure compliance with regulatory standards and product quality.

Scope: This procedure applies to the Aseptic Filling equipment (PFS/Vials) utilized in the production area for filling depot suspensions aseptically. It is applicable to all personnel involved in the validation and operation of this equipment.

Definitions:

• Equipment Validation: A documented process that demonstrates that equipment operates consistently and produces results that meet predetermined specifications.
• Criticality: The classification indicating the potential impact of the equipment on product quality and patient safety.
• CSV: Computerized System Validation, ensuring that computerized systems meet regulatory requirements.

Roles:

• Validation Team: Responsible for planning, executing, and documenting the validation activities.
• Quality Assurance: Ensures compliance with regulatory requirements and reviews validation documentation.
• Operations Personnel: Operate the equipment and provide input during the validation process.

Lifecycle Procedure:

1. Design Qualification (DQ): Verify that the equipment design meets user requirements.
2. Installation Qualification (IQ): Confirm that the equipment is installed correctly and in accordance with manufacturer specifications.
3. Operational Qualification (OQ): Validate that the equipment operates as intended within specified limits.
4. Performance Qualification (PQ): Demonstrate that the equipment consistently performs as required during actual production conditions.

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

Acceptance Criteria Governance: Acceptance criteria for validation shall adhere to URS, Annex 1, and Annex 11 guidelines, ensuring that all critical parameters are met during the validation process.

Calibration/PM Governance: All equipment must undergo regular calibration and preventive maintenance as per the manufacturer’s specifications and internal policies to ensure consistent performance.

Change Control Triggers: Any modifications to the equipment, processes, or materials that may affect the validated state must initiate a change control process.

Revalidation Triggers and Periodic Review: Revalidation is required every 12 months or upon significant changes to the equipment or processes to ensure continued compliance and performance.

Records/Attachments List:

• Validation Plan
• Validation Protocols (DQ/IQ/OQ/PQ)
• Calibration Certificates
• Change Control Documentation
• Revalidation Reports