Operational Qualification Protocol for Metering Pump in R&D/Production
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]
Objective
The objective of this Operational Qualification (OQ) protocol is to verify that the Solvent Addition / Metering Pump system operates within specified limits and meets the requirements outlined in the User Requirements Specification (URS) Annex11.
Scope
This protocol applies to the Solvent Addition / Metering Pump used in the R&D and Production areas for controlled solvent/API addition in the formulation of Polymeric Nanoparticles (PLGA etc.).
Responsibilities
The following personnel are responsible for the execution and oversight of this OQ protocol:
- Validation Team: Responsible for protocol execution and documentation.
- Quality Assurance: Responsible for review and approval of the OQ protocol.
- Operations: Responsible for providing access to the equipment and operational support.
Prerequisites
- Completion of Installation Qualification (IQ).
- Training of personnel on the operation of the Metering Pump.
- Availability of necessary documentation (URS, SOPs, etc.).
Equipment Description
The Solvent Addition / Metering Pump is a system designed for the precise addition of solvents and active pharmaceutical ingredients (APIs) in the formulation process of Polymeric Nanoparticles. Key features include:
- Flow accuracy: ±1% of set point
- Data logging capabilities for audit trails
- Adjustable flow rate settings
Test Plan
| Test ID | Procedure | Acceptance Criteria | Evidence |
|---|---|---|---|
| OQ-001 | Verify flow accuracy at specified set points. | Flow accuracy within ±1% of set point. | Calibration report, test data logs. |
| OQ-002 | Check addition profile and audit trail functionality. | Complete and accurate addition profile logged. | Audit trail report, system logs. |
Detailed Test Cases
Test Case OQ-001: Flow Accuracy
Procedure: Set the pump to a specific flow rate and measure the actual flow rate using a calibrated flow meter. Repeat for multiple set points.
Expected Outcome: The measured flow rates must be within ±1% of the set point.
Test Case OQ-002: Addition Profile and Audit Trail
Procedure: Conduct a solvent addition operation and verify that the system logs the addition profile accurately. Review the audit trail for completeness.
Expected Outcome: The audit trail must show complete and accurate records of the solvent addition process.
Deviations
Any deviations from the acceptance criteria during the execution of the OQ protocol must be documented and investigated. A deviation report must be generated and reviewed by the Quality Assurance team.
Approvals
This protocol must be approved by the following personnel:
- Validation Team Lead: ___________________ Date: __________
- Quality Assurance Manager: ______________ Date: __________
- Operations Manager: _____________________ Date: __________
Data Integrity Checks
As CSV is required, ensure the following data integrity checks are performed:
- Validation of data entry points during operation.
- Regular backups of data logs.
- Access controls to prevent unauthorized changes to logged data.