Document Control
Document Number: OQ-001
Version: 1.0
Effective Date: [Insert Date]
Review Date: [Insert Date]
Prepared By: [Insert Name]
Approved By: [Insert Name]
Operational Qualification Protocol for VHP Generator in NDDS
Meta Description: This document outlines the Operational Qualification protocol for the VHP Generator used in the decontamination of isolators and RABS in NDDS for Liposomes and Lipid Nanoparticles.
Objective
The objective of this Operational Qualification (OQ) protocol is to ensure that the VHP Generator / Decontamination Unit operates within specified limits and performs effectively for the decontamination of isolators and RABS in the production area.
Scope
This protocol applies to the VHP Generator / Decontamination Unit used in the production area for the decontamination process of isolators and RABS, impacting the direct product quality for Liposomes and Lipid Nanoparticles.
Responsibilities
The following roles are responsible for the execution and oversight of this protocol:
- Validation Team: Execute the OQ protocol and document results.
- Quality Assurance: Review and approve the OQ protocol and results.
- Production Personnel: Assist in the execution of tests and provide necessary data.
Prerequisites
- Completion of Installation Qualification (IQ) for the VHP Generator.
- Availability of all required documentation and equipment.
- Training of personnel on the operation of the VHP Generator.
Equipment Description
The VHP Generator / Decontamination Unit is designed to generate vaporized hydrogen peroxide for the decontamination of isolators and RABS. It operates within critical parameters such as concentration, dwell time, aeration, and residuals records.
Test Plan
| Test ID | Procedure | Acceptance Criteria | Evidence |
|---|---|---|---|
| OQ-01 | Verify VHP concentration levels during operation. | Concentration within specified limits. | Calibration records and concentration logs. |
| OQ-02 | Measure dwell time during decontamination cycles. | Dwell time meets defined specifications. | Dwell time records. |
| OQ-03 | Evaluate aeration effectiveness post-decontamination. | Aeration meets required parameters. | Aeration test results. |
| OQ-04 | Document residuals after decontamination. | Residuals within acceptable limits. | Residuals testing reports. |
Detailed Test Cases
Test Case OQ-01
Objective: Verify VHP concentration levels during operation.
Procedure: Start the VHP Generator and monitor concentration levels using calibrated sensors.
Acceptance Criteria: Concentration must be within specified limits as per URS Annex 11.
Evidence: Calibration records and concentration logs must be documented and reviewed.
Test Case OQ-02
Objective: Measure dwell time during decontamination cycles.
Procedure: Initiate a decontamination cycle and record the time for which the VHP is applied.
Acceptance Criteria: Dwell time must meet defined specifications.
Evidence: Dwell time records must be maintained and reviewed.
Test Case OQ-03
Objective: Evaluate aeration effectiveness post-decontamination.
Procedure: Measure air quality post-aeration using appropriate testing methods.
Acceptance Criteria: Aeration must meet required parameters.
Evidence: Aeration test results must be documented.
Test Case OQ-04
Objective: Document residuals after decontamination.
Procedure: Collect samples for residual testing following decontamination.
Acceptance Criteria: Residuals must be within acceptable limits.
Evidence: Residuals testing reports must be available for review.
Deviations
Any deviations from the protocol must be documented and justified. All deviations will require approval from Quality Assurance before proceeding with the next steps.
Approvals
This protocol requires signatures from the following individuals:
- Prepared By: _____________________
- Approved By: _____________________
- Quality Assurance: _____________________