In-vitro Release Testing System (Dialysis/Flow-through/USP apparatus as applicable) – Equipment Validation SOP

Standard Operating Procedure for the Validation of In-vitro Release Testing Systems

Purpose: This SOP outlines the validation process for the In-vitro Release Testing System used in QC/R&D for release profile testing, ensuring compliance with regulatory requirements and product integrity.

Scope: This procedure applies to the validation of the In-vitro Release Testing System categorized under NDDS – Critical NDDS Analytics, utilized for release profile testing in both Quality Control and Research & Development areas.

Definitions:

  • CQA: Critical Quality Attribute
  • CPP: Critical Process Parameter
  • DQ: Design Qualification
  • IQ: Installation Qualification
  • OQ: Operational Qualification
  • PQ: Performance Qualification
  • CSV: Computer System Validation

Roles:

  • Validation Team: Responsible for the execution of validation activities.
  • Quality Assurance: Ensures compliance with regulatory requirements and SOP adherence.
  • Technical Staff: Operates the equipment and performs testing.

Lifecycle Procedure:

  1. Design Qualification (DQ): Confirm equipment design meets user requirements.
  2. Installation Qualification (IQ): Verify equipment installation according to specifications.
  3. Operational Qualification (OQ): Validate that the equipment operates within defined limits.
  4. Performance Qualification (PQ): Ensure the equipment performs effectively for its intended use.

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

Acceptance Criteria Governance: Acceptance criteria must align with URS, Annex 11, and Annex 15 guidelines, ensuring all critical quality attributes and critical process parameters are met.

Calibration/PM Governance: The In-vitro Release Testing System must undergo regular calibration and preventive maintenance as per the manufacturer’s recommendations and internal policies to ensure consistent performance.

See also  Glass Lined Reactor (GLR) – OQ Protocol

Change Control Triggers: Any changes to the equipment, software, or processes must initiate a change control process to assess impact on validation status.

Revalidation Triggers and Periodic Review: Revalidation must occur annually or upon significant changes in equipment, processes, or product specifications. A periodic review of the validation status must be conducted to ensure ongoing compliance.

Records/Attachments List:

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

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