Standard Operating Procedure for Equipment Validation of MDI Bulk Compounding Vessel
Purpose: This SOP outlines the validation process for the MDI Bulk Compounding Vessel (Jacketed SS) used in the preparation of suspension/solution for Metered Dose Inhalers (MDI).
Scope: This procedure applies to the validation of the MDI Bulk Compounding Vessel utilized in the production area for inhaler manufacturing.
Definitions:
- MDI: Metered Dose Inhaler
- DPI: Dry Powder Inhaler
- CSV: Computerized System Validation
- DQ: Design Qualification
- IQ: Installation Qualification
- OQ: Operational Qualification
- PQ: Performance Qualification
Roles:
- Validation Team: Responsible for the execution of validation protocols.
- Quality Assurance: Ensures compliance with regulatory requirements and SOPs.
- Operations: Operates the equipment and ensures adherence to procedures.
Lifecycle Procedure:
- Design Qualification (DQ): Review equipment specifications and ensure they meet user requirements.
- Installation Qualification (IQ): Verify that the equipment is installed correctly according to manufacturer specifications.
- Operational Qualification (OQ): Validate that the equipment operates according to predefined parameters.
- Performance Qualification (PQ): Confirm that the equipment consistently performs its intended function in a controlled environment.
GDP Controls: Good Documentation Practices (GDP) must be adhered to throughout the validation process, ensuring all records are complete, accurate, and legible.
Acceptance Criteria Governance: Acceptance criteria must be established and documented for each validation phase, and must be reviewed annually (12M) to ensure continued compliance.
Calibration/PM Governance: Equipment must undergo regular calibration and preventative maintenance as per the defined schedule to ensure operational integrity.
Change Control Triggers: Any changes to the equipment, processes, or materials that may impact validation status must be documented and assessed through a formal change control process.
Revalidation Triggers and Periodic Review: Revalidation is required upon significant changes to the equipment or process, or at a minimum frequency of every 36 months. Periodic reviews must be conducted to assess the continued appropriateness of the validation status.
Records/Attachments List:
- Validation Protocols
- Validation Reports
- Calibration Certificates
- Maintenance Logs
- Change Control Documents