Document Control
Document Number: IQ-MM-001
Version: 1.0
Effective Date: [Insert Date]
Reviewed By: [Insert Name]
Approved By: [Insert Name]
Installation Qualification Protocol for Multi Mill Equipment
Objective: To establish that the Multi Mill is installed according to manufacturer specifications and is operationally capable of milling/sizing powders/granules as per defined acceptance criteria.
Scope: This protocol applies to the installation qualification of the Multi Mill used in the production area for solid dosage form manufacturing.
Responsibilities:
- Validation Team: Responsible for conducting the IQ protocol and documenting results.
- Maintenance Team: Responsible for ensuring the equipment is installed and maintained according to specifications.
- Quality Assurance: Responsible for reviewing and approving the IQ protocol and results.
Prerequisites:
- Installation of equipment must be completed.
- Utilities (electricity, water, etc.) must be verified and functional.
- Personnel must be trained on the operation of the Multi Mill.
Equipment Description:
The Multi Mill is designed for milling and sizing powders and granules. It operates using a rotor mechanism that ensures uniform particle size distribution.
| Test ID | Procedure | Acceptance Criteria | Evidence |
|---|---|---|---|
| IQ-01 | Verify rotor speed settings | Rotor speed must be within specified range as per URS | Calibration report |
| IQ-02 | Inspect screen integrity | No visible damage or wear | Inspection log |
| IQ-03 | Measure output particle size distribution (PSD) | Output PSD must meet specifications outlined in URS | Test results |
Detailed Test Cases:
Test Case 1: Verify Rotor Speed Settings
Procedure: Measure the rotor speed using a calibrated tachometer.
Acceptance Criteria: Rotor speed must be within the specified range as per URS.
Evidence: Document calibration report showing rotor speed measurements.
Test Case 2: Inspect Screen Integrity
Procedure: Visually inspect the screen for any signs of damage or wear.
Acceptance Criteria: No visible damage or wear should be present.
Evidence: Document results in the inspection log.
Test Case 3: Measure Output Particle Size Distribution (PSD)
Procedure: Collect samples of the output and analyze using appropriate particle size analysis equipment.
Acceptance Criteria: Output PSD must meet specifications outlined in URS.
Evidence: Test results documented and filed.
Deviations:
Any deviations from the acceptance criteria must be documented and investigated. Corrective actions should be taken as necessary.
Approvals:
Signature of Validation Team: ______________________
Signature of Maintenance Team: ____________________
Signature of Quality Assurance: ____________________