Purpose

The purpose of this SOP is to establish a standardized process for the validation of the Sterile Powder Compounding Vessel to ensure compliance with regulatory requirements and to maintain product quality.

Scope

This SOP applies to the Sterile Powder Compounding Vessel (Jacketed SS) used in the production area for preparing sterile bulk solutions prior to lyophilization.

Definitions

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

Roles

Key roles involved in the validation process include:

• Validation Manager
• Quality Assurance Personnel
• Production Staff
• Maintenance Personnel

Lifecycle Procedure

The validation lifecycle for the Sterile Powder Compounding Vessel includes:

1. Design Qualification (DQ)
2. Installation Qualification (IQ)
3. Operational Qualification (OQ)
4. Performance Qualification (PQ)

GDP Controls

Good Documentation Practices (GDP) must be followed throughout the validation process to ensure all documentation is accurate, complete, and traceable.

Acceptance Criteria Governance

Acceptance criteria must align with URS, Annex 1, Annex 11, and Annex 15 guidelines. All criteria must be met during each phase of validation.

Calibration/PM Governance

Calibration and preventive maintenance (PM) must be performed according to the manufacturer’s specifications and documented in the maintenance log.

Change Control Triggers

Change control must be initiated for any modifications to the equipment, process, or materials that may impact validation status.

Revalidation Triggers and Periodic Review

Revalidation is required every 12 months or when significant changes occur to the equipment or processes.

Records/Attachments List

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