Zeta Potential Analyzer – Equipment Validation SOP

Standard Operating Procedure for the Validation of Zeta Potential Analyzer

Equipment Validation,
NDDS,
Critical NDDS Analytics,
Zeta Potential Analyzer,
QC,
R&D

Purpose

This Standard Operating Procedure (SOP) provides guidelines for the validation of the Zeta Potential Analyzer to ensure compliance with regulatory requirements and to guarantee the quality of analytical results impacting product development.

Scope

This SOP applies to the validation of the Zeta Potential Analyzer used in Quality Control (QC) and Research & Development (R&D) areas for surface charge measurement of nanoparticles and other materials.

Definitions

  • DQ: Design Qualification
  • IQ: Installation Qualification
  • OQ: Operational Qualification
  • PQ: Performance Qualification
  • CSV: Computerized System Validation
  • URS: User Requirements Specification

Roles

  • Validation Team: Responsible for the overall validation process.
  • Quality Assurance: Ensures compliance with regulatory standards.
  • Laboratory Personnel: Conducts testing and documentation.

Lifecycle Procedure

  1. Design Qualification (DQ): Document requirements and specifications.
  2. Installation Qualification (IQ): Verify installation and configuration.
  3. Operational Qualification (OQ): Validate operational parameters.
  4. Performance Qualification (PQ): Confirm performance against critical quality attributes.

GDP Controls

Good Documentation Practices (GDP) must be followed throughout the validation process, ensuring all records are clear, accurate, and complete.

Acceptance Criteria Governance

Acceptance criteria will be established based on the User Requirements Specification (URS) and Annex 11 of the relevant regulatory guidelines. All results must meet these criteria for the validation to be considered successful.

Calibration/PM Governance

The Zeta Potential Analyzer will be calibrated and maintained according to the manufacturer’s specifications and internal Standard Operating Procedures. Calibration must be performed at least annually.

See also  Inline Conductivity Meter – DQ Protocol

Change Control Triggers

Any changes to the equipment, software, or operating procedures must initiate a change control process, including re-evaluation of the validation status.

Revalidation Triggers and Periodic Review

Revalidation is required annually or when significant changes occur. Periodic reviews of validation status should be conducted to ensure ongoing compliance and performance.

Records/Attachments List

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

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