Operational Qualification Protocol for Inline Particle Size Analyzer in NDDS Production
Document Control:
Document Number: OQ-PSA-001
Version: 1.0
Effective Date: [Insert Date]
Review Date: [Insert Date]
Prepared by: [Your Name]
Approved by: [Approver’s Name]
Objective
The objective of this protocol is to establish the operational qualification of the Inline Particle Size Analyzer (PAT) used for monitoring particle size in the production of long-acting injectables.
Scope
This protocol applies to the Inline Particle Size Analyzer used in the production area for NDDS – Long-Acting Injectables. It encompasses the qualification activities necessary to ensure that the equipment operates within the specified parameters.
Responsibilities
The Validation Team is responsible for executing this protocol and documenting all findings. The Quality Assurance (QA) department will review and approve the qualification results.
Prerequisites
All personnel involved in the execution of this protocol must be trained in the use of the Inline Particle Size Analyzer and familiar with the relevant SOPs.
Equipment Description
The Inline Particle Size Analyzer (PAT) is designed to monitor particle size during the production of long-acting injectables. It provides real-time data to ensure that particle size remains within the established specifications.
Test Plan
| Test ID | Procedure | Acceptance Criteria | Evidence |
|---|---|---|---|
| OQ-1 | Verify calibration of the PAT | Calibration within specified limits | Calibration certificate |
| OQ-2 | Perform accuracy checks | Accuracy within ±5% of target | Accuracy test report |
| OQ-3 | Assess precision of measurements | Precision within 2% CV | Precision test report |
| OQ-4 | Verify data integrity | No data loss or corruption | Data integrity audit report |
Detailed Test Cases
Test Case OQ-1
Objective: Verify the calibration of the Inline Particle Size Analyzer.
Procedure: Follow the calibration SOP to calibrate the PAT using certified standards.
Acceptance Criteria: Calibration must be within specified limits.
Evidence: Calibration certificate must be attached to the protocol.
Test Case OQ-2
Objective: Perform accuracy checks on the Inline Particle Size Analyzer.
Procedure: Measure known standards and compare to expected values.
Acceptance Criteria: Accuracy must be within ±5% of the target value.
Evidence: Accuracy test report must be attached.
Test Case OQ-3
Objective: Assess the precision of the measurements.
Procedure: Perform multiple measurements of the same sample and calculate the CV.
Acceptance Criteria: Precision must be within 2% CV.
Evidence: Precision test report must be attached.
Test Case OQ-4
Objective: Verify data integrity of the Inline Particle Size Analyzer.
Procedure: Review data logs and perform an integrity audit.
Acceptance Criteria: No data loss or corruption should be observed.
Evidence: Data integrity audit report must be attached.
Deviations
Any deviations from this protocol must be documented in the deviation log and approved by the QA department.
Approvals
Prepared by: ______________________
Date: ______________________
Approved by: ______________________
Date: ______________________
Data Integrity Checks
1. Ensure that all data generated by the PAT is automatically logged and stored securely.
2. Regularly back up data to prevent loss.
3. Implement access controls to ensure only authorized personnel can modify data.