Document ID: DQ-001
Version: 1.0
Effective Date: 2023-10-01
Prepared By: [Your Name]
Reviewed By: [Reviewer Name]
Approval Date: [Approval Date]
Design Qualification Protocol for Depot Suspension Preparation Vessel
This document outlines the Design Qualification (DQ) protocol for the Depot Suspension Preparation Vessel used in the production of long-acting injectables.
Objective: To ensure that the Depot Suspension Preparation Vessel meets all requirements for the preparation of depot suspensions, ensuring product quality and compliance with regulatory standards.
Scope: This protocol applies to the validation of the Depot Suspension Preparation Vessel within the production area, focusing on its use for preparing depot suspensions.
Responsibilities:
- Validation Team: Responsible for executing the DQ protocol and documenting results.
- Quality Assurance: Responsible for reviewing and approving the DQ protocol and results.
- Production Team: Responsible for operating the equipment during the validation process.
Prerequisites:
- Completion of User Requirement Specification (URS).
- Installation Qualification (IQ) of the equipment.
- Training of personnel on equipment operation.
Equipment Description:
The Depot Suspension Preparation Vessel is designed to prepare depot suspensions with the following capabilities:
- Agitation speed control
- Temperature control
- Viscosity measurement
- Time recording
| Test ID | Procedure | Acceptance Criteria | Evidence |
|---|---|---|---|
| DQ-01 | Verify agitation speed settings. | Agitation speed within specified range. | Calibration records, Speed measurement logs. |
| DQ-02 | Check temperature control accuracy. | Temperature maintained within ±2°C. | Temperature logs, Calibration certificates. |
| DQ-03 | Measure viscosity of prepared suspensions. | Viscosity within specified limits. | Viscosity test results. |
| DQ-04 | Record preparation time. | Preparation time within specified limits. | Time logs. |
Detailed Test Cases:
- Test Case DQ-01: Verify that the agitation speed can be set and maintained within the specified range. Document the set speed and the actual speed recorded.
- Test Case DQ-02: Measure the temperature of the preparation vessel during operation to ensure it remains within the acceptance criteria. Document temperature readings at regular intervals.
- Test Case DQ-03: Prepare a sample batch and measure its viscosity using a viscometer. Document the viscosity results against acceptance criteria.
- Test Case DQ-04: Record the total time taken for the preparation process and ensure it adheres to the specified limits. Document the start and end times.
Deviations:
Any deviations from the acceptance criteria must be documented and assessed for impact on product quality. Appropriate corrective actions must be taken and recorded.
Approvals:
Prepared by: ________________________ Date: ___________
Reviewed by: ________________________ Date: ___________
Approved by: ________________________ Date: ___________