Standard Operating Procedure for the Validation of Conductivity Meter in QC Laboratory

Purpose

This SOP outlines the validation process for the Conductivity Meter used in the QC Laboratory to ensure accurate conductivity measurements and compliance with regulatory standards.

Scope

This procedure applies to the Conductivity Meter utilized in the QC Lab for conductivity measurement, affecting product quality directly.

Definitions

• Conductivity Meter: An instrument used to measure the electrical conductivity in solutions.
• Validation: The process of establishing documented evidence that a system or process meets its intended requirements.
• CSV: Computer System Validation.

Roles

• Quality Assurance (QA): Responsible for oversight and compliance of validation activities.
• Quality Control (QC): Responsible for performing and documenting the validation tests.
• Validation Team: Responsible for planning and executing validation protocols.

Lifecycle Procedure

1. Design Qualification (DQ): Assess the user requirements and specifications.
2. Installation Qualification (IQ): Verify that the Conductivity Meter is installed correctly and meets specifications.
3. Operational Qualification (OQ): Ensure that the Conductivity Meter operates according to its intended use.
4. Performance Qualification (PQ): Confirm that the Conductivity Meter performs effectively in a controlled environment.

GDP Controls

Good Documentation Practices (GDP) must be followed throughout the validation process, including accurate and complete documentation of all validation activities and results.

Acceptance Criteria Governance

Acceptance criteria must align with the User Requirement Specification (URS) and Annex 11 of the relevant regulations. All criteria must be met for a successful validation.

Calibration/PM Governance

Calibration and preventive maintenance (PM) must be performed according to the manufacturer’s specifications and documented in the maintenance log. Calibration frequency must be established based on risk assessment.

Change Control Triggers

Any changes in equipment, software, or processes that may impact the Conductivity Meter’s performance must be evaluated and documented through the change control process.

Revalidation Triggers and Periodic Review

Revalidation is required every 12 months or when significant changes occur. Periodic reviews of the validation status and compliance will be conducted annually.

Records/Attachments List

• Validation Protocols
• Validation Summary Reports
• Calibration Certificates
• Maintenance Logs
• Change Control Documentation