Standard Operating Procedure for Dynamic Light Scattering Analyzer Equipment Validation

Purpose: This SOP outlines the procedures for the validation of the Dynamic Light Scattering (DLS) Analyzer to ensure compliance with regulatory requirements and to guarantee reliable measurement of particle size and polydispersity index (PDI).

Scope: This procedure applies to the validation of the DLS Analyzer used within the Quality Control (QC) and Research & Development (R&D) areas for critical NDDS analytics.

Definitions:

• DLS: Dynamic Light Scattering, a technique used for measuring the size of particles in suspension or polymers in solution.
• CQA: Critical Quality Attribute, a physical, chemical, biological, or microbiological property or characteristic that should be within a certain limit to ensure the desired product quality.
• CPP: Critical Process Parameter, a process parameter that must be controlled to ensure that a product meets its critical quality attributes.

Roles:

• Validation Manager: Responsible for overseeing the validation process and ensuring compliance with SOPs and regulatory requirements.
• Quality Assurance: Ensures that all validation activities are documented and compliant with internal and external standards.
• Laboratory Personnel: Conducts validation activities and performs routine operation of the DLS Analyzer.

Lifecycle Procedure:

1. Design Qualification (DQ): Assess the design specifications of the DLS Analyzer to ensure they meet user requirements.
2. Installation Qualification (IQ): Verify that the DLS Analyzer is installed according to manufacturer specifications and operational requirements.
3. Operational Qualification (OQ): Confirm that the DLS Analyzer operates within defined limits and specifications.
4. Performance Qualification (PQ): Validate that the DLS Analyzer consistently performs as intended under actual operating conditions.

GDP Controls: All validation activities must adhere to Good Documentation Practices (GDP) to ensure accuracy, traceability, and compliance.

Acceptance Criteria Governance: Acceptance criteria will be established based on User Requirement Specifications (URS) in compliance with Annex 11. All results must meet predefined acceptance limits for particle size and PDI.

Calibration/PM Governance: The DLS Analyzer must be calibrated and maintained according to the manufacturer’s recommendations and internal calibration schedules. Calibration records must be maintained for audit purposes.

Change Control Triggers: Any changes to the DLS Analyzer, including software updates, hardware modifications, or changes in operating procedures, must follow the change control process to assess impact on validation status.

Revalidation Triggers and Periodic Review: Revalidation is required annually or when significant changes occur. A periodic review of the validation status must be conducted to ensure ongoing compliance and performance.

Records/Attachments List:

• Validation Protocols
• Calibration Records
• Change Control Records
• Training Records
• Periodic Review Reports