Operational Qualification Protocol for Viscometer/Rheometer in NDDS Analytics

Objective: To establish the operational qualification for the Viscometer/Rheometer used in critical NDDS analytics to ensure compliance with specified performance criteria.

Scope: This protocol applies to the Operational Qualification of the Viscometer/Rheometer utilized in the QC/R&D area for viscosity and rheology measurements impacting product delivery performance.

Responsibilities:

• Validation Team: Execute the OQ protocol and document results.
• Quality Assurance: Review and approve the OQ protocol and results.
• Equipment Owner: Ensure equipment is maintained and calibrated prior to OQ execution.

Prerequisites:

• Equipment must be installed and calibrated according to manufacturer’s specifications.
• All personnel involved must be trained on the operation of the Viscometer/Rheometer.
• Relevant Standard Operating Procedures (SOPs) must be available and followed.

Equipment Description:

The Viscometer/Rheometer is an instrument designed to measure the viscosity and rheological properties of fluids. It is critical for assessing delivery performance in NDDS applications.

Detailed Test Cases:

Test Case OQ-001: Accuracy Test

Objective: To verify the accuracy of the Viscometer/Rheometer.

Procedure: Use standard viscosity solutions of known values and measure viscosity with the instrument.

Acceptance Criteria: Accuracy within ±2% of expected values.

Evidence: Calibration report and test results to be documented.

Test Case OQ-002: Repeatability Test

Objective: To assess the repeatability of the viscosity measurements.

Procedure: Perform three consecutive measurements on the same sample and calculate the standard deviation.

Acceptance Criteria: Standard deviation < 1% of mean viscosity.

Evidence: Statistical analysis report detailing results.

Test Case OQ-003: Audit Trail Verification

Objective: To ensure the audit trail functionality is operational.

Procedure: Execute a test run while monitoring the audit trail functionality.

Acceptance Criteria: Complete audit trail for all test runs.

Evidence: Printout of the audit log for review.

Deviations: Any deviations from the acceptance criteria must be documented and investigated. A root cause analysis should be performed, and corrective actions must be implemented.

Approvals:

• Validation Team Lead: ________________________ Date: __________
• Quality Assurance Manager: ___________________ Date: __________
• Equipment Owner: ____________________________ Date: __________

Data Integrity Checks:

• Verify data entry against source data for accuracy.
• Check for any unauthorized changes in the audit trail.
• Ensure backup of data is performed regularly.