Document Control
Document ID: IQ-DS-PV-001
Version: 1.0
Effective Date: [Insert Date]
Reviewed By: [Insert Name]
Approval Date: [Insert Date]
Installation Qualification Protocol for Depot Suspension Preparation Vessel
Objective: To establish and document the Installation Qualification (IQ) for the Depot Suspension Preparation Vessel to ensure it meets specified requirements for the preparation of depot suspensions.
Scope: This protocol applies to the Installation Qualification of the Depot Suspension Preparation Vessel used in the production area for preparing depot suspensions with a direct impact on product quality.
Responsibilities:
- Validation Team: Responsible for the execution and documentation of the IQ protocol.
- Quality Assurance: Responsible for reviewing and approving the IQ protocol.
- Production Team: Responsible for the operational aspects of the equipment during the IQ execution.
Prerequisites:
- Completion of equipment installation as per manufacturer specifications.
- All utilities connected and operational (electricity, water, compressed air).
- Personnel trained on equipment operation and safety protocols.
Equipment Description:
The Depot Suspension Preparation Vessel is a critical piece of equipment used in the production of long-acting injectable formulations. It is designed for the preparation of depot suspensions and is equipped with features to control agitation speed, temperature, viscosity, and time.
| Test ID | Procedure | Acceptance Criteria | Evidence |
|---|---|---|---|
| IQ-01 | Verify agitation speed settings | Agitation speed must be within specified range as per URS | Calibration records |
| IQ-02 | Verify temperature control functionality | Temperature must remain within specified limits during operation | Temperature logs |
| IQ-03 | Check viscosity measurement accuracy | Viscosity must meet specifications | Viscosity test results |
| IQ-04 | Document time settings | Time settings must be programmable and functional | Time setting logs |
| IQ-05 | Review all operational records | All records must be complete and accurate | Review of documentation |
Detailed Test Cases:
Test Case IQ-01:
- Procedure: Set the agitation speed to the specified value and verify the displayed speed.
- Acceptance Criteria: The displayed speed must match the set value.
- Evidence: Record the displayed speed in the validation log.
Test Case IQ-02:
- Procedure: Set the temperature to the desired setting and monitor the actual temperature.
- Acceptance Criteria: The actual temperature must remain within ±2°C of the set value.
- Evidence: Record the temperature readings at intervals in the validation log.
Test Case IQ-03:
- Procedure: Measure the viscosity of a standard solution using the vessel’s viscosity measurement system.
- Acceptance Criteria: The measured viscosity must fall within the specified range.
- Evidence: Document the viscosity measurement results.
Test Case IQ-04:
- Procedure: Program the time settings and initiate a timed operation.
- Acceptance Criteria: The timer must count down accurately and stop at the designated time.
- Evidence: Record the timer functionality in the validation log.
Test Case IQ-05:
- Procedure: Review all operational records generated during the test.
- Acceptance Criteria: All records must be complete, accurate, and legible.
- Evidence: Provide a summary of the reviewed records.
Deviations:
Any deviations from the acceptance criteria must be documented in a deviation report, including the root cause analysis and corrective actions taken.
Approvals:
Approval by:
- Validation Team: ___________________ Date: __________
- Quality Assurance: ___________________ Date: __________
- Production Manager: ___________________ Date: __________