Equipment Validation SOP for Depot Suspension Preparation Vessel

Purpose: To establish a standardized procedure for the validation of the Depot Suspension Preparation Vessel used in the production of long-acting injectables.

Scope: This SOP applies to the validation activities of the Depot Suspension Preparation Vessel located in the production area, specifically for long-acting injectable formulations.

Definitions:

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

Roles:

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

Lifecycle Procedure:

1. Conduct Design Qualification (DQ) to ensure the equipment meets user requirements.
2. Perform Installation Qualification (IQ) to verify the equipment is installed correctly.
3. Execute Operational Qualification (OQ) to demonstrate the equipment operates within specified limits.
4. Complete Performance Qualification (PQ) to confirm the equipment performs as intended during actual production.

Good Documentation Practices (GDP) Controls:

• All validation activities must be documented in accordance with GDP.
• Records must be signed and dated by responsible personnel.

Acceptance Criteria Governance:

• Acceptance criteria shall be defined in the User Requirements Specification (URS) and must comply with Annex 11 and Annex 15 of the applicable regulations.

Calibration/PM Governance:

• The equipment must be calibrated and maintained according to the established Preventive Maintenance (PM) schedule.
• Calibration records must be retained for review.

Change Control Triggers:

• Any changes to the equipment, process, or materials must initiate a change control process.

Revalidation Triggers and Periodic Review:

• Revalidation is required every 12 months or whenever there is a significant change to the equipment or process.
• Periodic reviews must be conducted to ensure ongoing compliance and performance.

Records/Attachments List:

• Validation Protocols
• Validation Reports
• Calibration Certificates
• Change Control Records
• Periodic Review Documentation