Design Qualification Protocol for Colloid Mill in Nasal & Otic Product Production
Document Number: DQ-001
Revision: 1.0
Effective Date: 2023-10-01
Prepared by: [Your Name]
Approved by: [Approver Name]
Objective
The objective of this Design Qualification (DQ) Protocol is to ensure that the Colloid Mill used in the production of Nasal and Otic products meets the specified requirements and operates as intended.
Scope
This protocol applies to the Colloid Mill utilized in the production area for the reduction of particle size in both sterile and non-sterile nasal and otic products.
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 in accordance with the DQ protocol.
Prerequisites
- Completion of User Requirements Specification (URS).
- Installation Qualification (IQ) completed for the Colloid Mill.
- Training of personnel on the operation of the Colloid Mill.
Equipment Description
The Colloid Mill is a high-shear mixer designed to reduce the particle size of materials. It operates by using a combination of mechanical shear and hydraulic shear to achieve the desired particle size.
Test Plan
| Test ID | Procedure | Acceptance Criteria | Evidence |
|---|---|---|---|
| T1 | Verify gap speed settings during operation. | Gap speed must be within specified range as per URS. | Calibration records and operation logs. |
| T2 | Measure particle size post-processing. | Particle size must meet specifications outlined in URS. | Particle size analysis report. |
Detailed Test Cases
Test Case T1: Verify Gap Speed Settings
Procedure: Set the Colloid Mill to the specified gap speed and monitor the readings. Document any deviations from the expected range.
Acceptance Criteria: The gap speed must remain within the specified range as outlined in the URS.
Evidence: Calibration records and operation logs must be maintained and reviewed.
Test Case T2: Measure Particle Size
Procedure: Collect samples of the processed material and conduct particle size analysis using appropriate methods.
Acceptance Criteria: The particle size must meet specifications outlined in the URS.
Evidence: A particle size analysis report must be generated and reviewed.
Deviations
Any deviations from the acceptance criteria must be documented and investigated. A corrective action plan must be developed and implemented as necessary.
Approvals
Prepared by: ______________________
Date: ______________________
Approved by: ______________________
Date: ______________________