Document Control:
Document Number: PQ-001
Version: 1.0
Effective Date: [Insert Date]
Reviewed By: [Insert Name]
Approval Date: [Insert Date]
Performance Qualification Protocol for Microfluidic Mixer in Liposome and LNP Formation
Objective
The objective of this Performance Qualification (PQ) protocol is to validate the Microfluidic Mixer for controlled nanoparticle formation in the production of Liposomes and Lipid Nanoparticles (LNP).
Scope
This protocol applies to the Microfluidic Mixer utilized in the R&D and production areas for the formulation of Liposomes and LNPs.
Responsibilities
- Validation Team: Overall execution and documentation of the PQ protocol.
- Quality Assurance: Review and approval of the PQ protocol and results.
- Operations: Execution of the test plan and adherence to the documented procedures.
Prerequisites
- Completion of Installation Qualification (IQ) and Operational Qualification (OQ).
- Training of personnel on equipment operation.
- Availability of necessary materials for testing.
Equipment Description
The Microfluidic Mixer is a system designed for the controlled formation of Liposomes and LNPs through precise manipulation of flow rates and mixing conditions.
Test Plan
| Test ID | Procedure | Acceptance Criteria | Evidence |
|---|---|---|---|
| PQ-01 | Verify flow ratio | Flow ratio within specified limits | Flow rate logs |
| PQ-02 | Measure total flow rate | Total flow rate meets specifications | Flow rate logs |
| PQ-03 | Check temperature | Temperature within acceptable range | Temperature logs |
| PQ-04 | Monitor mixing time | Mixing time meets defined criteria | Mixing time logs |
| PQ-05 | Assess backpressure | Backpressure within defined limits | Backpressure logs |
| PQ-06 | Review audit trail | Complete and intact audit trail | Audit trail report |
Detailed Test Cases
PQ-01: Verify Flow Ratio
Procedure: Measure the flow ratio using calibrated flow meters.
Acceptance Criteria: Flow ratio should be within the specified limits as per URS Annex 11.
Evidence: Documented flow rate logs.
PQ-02: Measure Total Flow Rate
Procedure: Calculate total flow rate during operation.
Acceptance Criteria: Total flow rate must meet specifications outlined in URS Annex 15.
Evidence: Flow rate logs.
PQ-03: Check Temperature
Procedure: Monitor the temperature during operation.
Acceptance Criteria: Temperature remains within the acceptable range.
Evidence: Temperature logs.
PQ-04: Monitor Mixing Time
Procedure: Document mixing time for each batch.
Acceptance Criteria: Mixing time must meet defined criteria.
Evidence: Mixing time logs.
PQ-05: Assess Backpressure
Procedure: Measure backpressure during operation.
Acceptance Criteria: Backpressure must remain within defined limits.
Evidence: Backpressure logs.
PQ-06: Review Audit Trail
Procedure: Review the audit trail for completeness and integrity.
Acceptance Criteria: Audit trail should be complete and intact.
Evidence: Audit trail report.
Deviations
Any deviations from the acceptance criteria must be documented, investigated, and approved by the Validation Team and Quality Assurance.
Approvals
Prepared by: [Insert Name] – [Insert Title]
Approved by: [Insert Name] – [Insert Title]
Date: [Insert Date]