Document Control Number: OQ-001
Version: 1.0
Effective Date: 2023-10-01
Review Date: 2024-10-01
Operational Qualification Protocol for Sterile Filtration Skid in NDDS Production
Meta Description: This document outlines the Operational Qualification protocol for the Sterile Filtration Skid used in the production of NDDS, focusing on critical parameters and compliance with URS Annex1 Annex11.
Tags: Equipment Validation, Operational Qualification, Sterile Filtration, NDDS
Objective
The objective of this Operational Qualification (OQ) protocol is to verify that the Sterile Filtration Skid operates according to established specifications and is suitable for its intended use in the production of NDDS, particularly liposomes and lipid nanoparticles.
Scope
This protocol applies to the Sterile Filtration Skid used in the production area for sterilizing filtration. It encompasses the qualification activities necessary to ensure compliance with regulatory requirements and internal quality standards.
Responsibilities
- Validation Team: Responsible for executing the OQ protocol and documenting results.
- Quality Assurance: Responsible for reviewing and approving the protocol and results.
- Production Personnel: Responsible for operating the equipment as per the validated procedures.
Prerequisites
- Completion of Installation Qualification (IQ).
- Training of personnel on the operation of the Sterile Filtration Skid.
- Availability of all necessary documentation, including the User Requirement Specification (URS).
Equipment Description
The Sterile Filtration Skid is a system designed for the sterilization of liposomal and lipid nanoparticle formulations through filtration. It includes components such as filters, pumps, and monitoring systems to ensure effective sterilization.
Test Plan
| Test ID | Procedure | Acceptance Criteria | Evidence |
|---|---|---|---|
| OQ-01 | Verify flow rate during operation. | Flow rate within specified limits. | Flow rate log. |
| OQ-02 | Conduct DP integrity audit. | Integrity test results pass. | Integrity test report. |
Detailed Test Cases
Test Case OQ-01: Verify Flow Rate
Objective: Ensure that the Sterile Filtration Skid operates within the specified flow rate.
Procedure: Operate the skid under normal conditions and record the flow rate.
Acceptance Criteria: Flow rate must be within established limits as per URS.
Evidence: Documented flow rate log must be attached.
Test Case OQ-02: Conduct DP Integrity Audit
Objective: Validate the integrity of the filtration system.
Procedure: Perform a differential pressure integrity test on the filtration unit.
Acceptance Criteria: Integrity test results must indicate no breaches.
Evidence: Integrity test report must be attached.
Deviations
Any deviations from the protocol must be documented and justified. A deviation report will be generated for any test that does not meet acceptance criteria.
Approvals
Prepared by: ______________________
Date: ______________________
Approved by: ______________________
Date: ______________________