Document Control
Document Number: DQ-001
Version: 1.0
Effective Date: 2023-10-01
Reviewed By: [Name]
Approval Date: [Date]
Design Qualification Protocol for Inline/High Shear Homogenizer
Objective
The objective of this Design Qualification (DQ) protocol is to ensure that the Inline/High Shear Homogenizer is designed and installed in accordance with the specified requirements to ensure uniform API dispersion in the production of suppositories and implants.
Scope
This protocol applies to the validation of Inline/High Shear Homogenizers used in the production area for the manufacturing of suppositories and implants. It encompasses equipment qualification, operational parameters, and data integrity checks.
Responsibilities
The Validation Team is responsible for executing this protocol. Quality Assurance will oversee the approval process, while Production will provide operational support and access to the equipment.
Prerequisites
- Completion of User Requirement Specification (URS).
- Installation Qualification (IQ) of the equipment.
- Availability of necessary documentation (SOPs, maintenance logs).
Equipment Description
The Inline/High Shear Homogenizer is designed to achieve uniform dispersion of active pharmaceutical ingredients (APIs) in the formulation of suppositories and implants. Key features include adjustable speed settings, temperature control, and integrated PLC for data logging.
Test Plan
| Test ID | Procedure | Acceptance Criteria | Evidence |
|---|---|---|---|
| DQ-01 | Verify speed settings | Speed within specified range as per URS | Calibration logs |
| DQ-02 | Check temperature control | Temperature maintained within specified limits | Temperature logs |
| DQ-03 | Assess shear force | Shear force meets defined specifications | Shear force logs |
| DQ-04 | Review PLC logs | Logs show complete audit trail | PLC audit trail report |
Detailed Test Cases
Test Case DQ-01: Verify Speed Settings
Procedure: Adjust the speed settings on the homogenizer and record the actual speeds. Compare with the specified range in the URS.
Acceptance Criteria: Speed must be within the specified range.
Evidence: Calibration logs must be documented and reviewed.
Test Case DQ-02: Check Temperature Control
Procedure: Operate the homogenizer and monitor temperature throughout the process.
Acceptance Criteria: Temperature must remain within specified limits.
Evidence: Temperature logs must be maintained for review.
Test Case DQ-03: Assess Shear Force
Procedure: Measure the shear force during operation using calibrated equipment.
Acceptance Criteria: Shear force must meet defined specifications.
Evidence: Shear force logs must be documented.
Test Case DQ-04: Review PLC Logs
Procedure: Access PLC logs and verify the completeness of the audit trail.
Acceptance Criteria: Logs must show a complete audit trail without discrepancies.
Evidence: PLC audit trail report must be available for review.
Deviations
Any deviations from the acceptance criteria must be documented and addressed through a formal change control process. Investigations must be conducted to determine the root cause and corrective actions implemented.
Approvals
All results must be reviewed and approved by the Validation Manager and Quality Assurance prior to final acceptance of the equipment for use in production.