Document ID: DQ-RMG-001
Version: 1.0
Date: 2023-10-03
Prepared by: [Your Name]
Approved by: [Approver’s Name]
Design Qualification Protocol for Rapid Mixer Granulator (RMG)
Objective
The objective of this Design Qualification (DQ) Protocol is to ensure that the Rapid Mixer Granulator (RMG) is installed and operates according to the specified requirements for wet granulation processes in the production of solid dosage forms.
Scope
This protocol applies to the Design Qualification of the Rapid Mixer Granulator used in the production area for wet granulation processes. It encompasses all activities related to the installation, operational qualification, and performance verification of the equipment.
Responsibilities
- Validation Team: Prepare and execute the DQ protocol.
- Quality Assurance: Review and approve the DQ protocol.
- Production Team: Provide input on equipment requirements and operational use.
Prerequisites
- Completion of equipment installation.
- Availability of relevant documentation (URS, FS, SDS).
- Training of personnel on equipment operation.
Equipment Description
The Rapid Mixer Granulator (RMG) is used for the wet granulation process in solid dosage form manufacturing. It combines the functions of mixing and granulating in a single unit, ensuring uniform distribution of moisture and active ingredients.
Test Plan
| Test ID | Procedure | Acceptance | Evidence |
|---|---|---|---|
| T1 | Verify impeller speed settings | Within specified range (e.g., 50-150 RPM) | Calibration records |
| T2 | Check chopper speed settings | Within specified range (e.g., 30-120 RPM) | Calibration records |
| T3 | Monitor torque during operation | Torque within specified limits | Torque data logs |
| T4 | Verify PLC alarm functionality | All alarms trigger appropriately | Alarm test logs |
Detailed Test Cases
Test Case T1: Impeller Speed Verification
Procedure: Set the impeller speed to the desired RPM and verify using a calibrated tachometer.
Acceptance Criteria: Impeller speed must be within the specified range.
Evidence: Record readings and attach calibration certificate.
Test Case T2: Chopper Speed Verification
Procedure: Set the chopper speed to the desired RPM and verify using a calibrated tachometer.
Acceptance Criteria: Chopper speed must be within the specified range.
Evidence: Record readings and attach calibration certificate.
Test Case T3: Torque Monitoring
Procedure: Monitor torque during operation and record values.
Acceptance Criteria: Torque must remain within specified limits throughout the granulation process.
Evidence: Attach torque data logs.
Test Case T4: PLC Alarm Functionality
Procedure: Simulate alarm conditions and verify that the PLC triggers the appropriate alarms.
Acceptance Criteria: All alarms must trigger as expected.
Evidence: Document alarm test results.
Deviations
Any deviations from the acceptance criteria must be documented and investigated. A root cause analysis should be performed, and corrective actions must be taken as necessary.
Approvals
Prepared by: ______________________ Date: __________
Reviewed by: ______________________ Date: __________
Approved by: ______________________ Date: __________