Document Number: OQ-DS-PV-001
Version: 1.0
Effective Date: 2023-10-01
Reviewed By: [Name]
Approval Date: [Date]
Operational Qualification Protocol for Depot Suspension Preparation Vessel
Tags: Equipment Validation, Operational Qualification, Depot Suspension, Long-Acting Injectables
Objective
The objective of this protocol is to establish the operational qualification of the Depot Suspension Preparation Vessel to ensure it meets the specified requirements for preparing depot suspensions.
Scope
This protocol applies to the operational qualification of the Depot Suspension Preparation Vessel located in the Production area, used for preparing depot suspensions with direct product impact.
Responsibilities
The Validation Team is responsible for executing this protocol. Quality Assurance will review and approve the results.
Prerequisites
- Completion of Installation Qualification (IQ).
- Training of personnel on the use of the equipment.
- Availability of necessary materials for testing.
Equipment Description
The Depot Suspension Preparation Vessel is designed for the preparation of depot suspensions. It incorporates features for precise control of agitation speed, temperature, viscosity, and time, ensuring compliance with product specifications.
Test Plan
| Test ID | Procedure | Acceptance Criteria | Evidence |
|---|---|---|---|
| OQ-DS-01 | Verify agitation speed settings | Agitation speed within specified range | Calibration records |
| OQ-DS-02 | Measure temperature during operation | Temperature maintained within specified limits | Temperature logs |
| OQ-DS-03 | Assess viscosity of the product | Viscosity within acceptable range | Viscosity test results |
| OQ-DS-04 | Monitor operation time | Operation time within set parameters | Time logs |
Detailed Test Cases
Test Case OQ-DS-01: Verify Agitation Speed Settings
Procedure: Set the agitation speed to the required levels and verify using calibrated equipment.
Acceptance Criteria: Agitation speed must be within the specified range.
Evidence: Calibration records to confirm speed accuracy.
Test Case OQ-DS-02: Measure Temperature During Operation
Procedure: Operate the vessel and record the temperature at specified intervals.
Acceptance Criteria: Temperature must remain within specified limits throughout the operation.
Evidence: Temperature logs documenting the readings.
Test Case OQ-DS-03: Assess Viscosity of the Product
Procedure: Sample the product at the end of the preparation and measure viscosity using a viscometer.
Acceptance Criteria: Viscosity must fall within the acceptable range.
Evidence: Viscosity test results provided by the viscometer.
Test Case OQ-DS-04: Monitor Operation Time
Procedure: Record the total operation time and compare with the defined parameters.
Acceptance Criteria: Operation time should be within the set parameters.
Evidence: Time logs maintained during the operation.
Deviations
Any deviations from the acceptance criteria must be documented and assessed to determine their impact on the qualification process. Appropriate corrective actions should be implemented as necessary.
Approvals
This protocol requires approval from the Quality Assurance department upon successful completion of all tests and documentation of results.