DPI – Equipment Validation SOP

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:

  1. Design Qualification (DQ): Review equipment specifications and ensure they meet user requirements.
  2. Installation Qualification (IQ): Verify that the equipment is installed correctly according to manufacturer specifications.
  3. Operational Qualification (OQ): Validate that the equipment operates according to predefined parameters.
  4. 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.

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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

Also Check:

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