Installation Qualification Protocol for Co-Mill / Conical Mill
Document Control:
Document Number: IQ-OSD-001
Version: 1.0
Effective Date: 2023-10-01
Reviewed by: [Name]
Approval Date: [Date]
Objective
The objective of this Installation Qualification (IQ) protocol is to verify that the Co-Mill / Conical Mill is installed according to the manufacturer’s specifications and is functioning as intended for the de-agglomeration and sizing of solid dosage forms.
Scope
This protocol applies to the Co-Mill / Conical Mill located in the Production/Milling area and is intended for direct impact on product quality.
Responsibilities
The Validation Team is responsible for executing this protocol, documenting results, and ensuring compliance with relevant regulatory requirements.
Prerequisites
- Installation of equipment must be completed.
- All utilities (electrical, water, compressed air) must be operational.
- Personnel must be trained on equipment operation.
Equipment Description
The Co-Mill / Conical Mill is designed for the de-agglomeration and sizing of solid dosage forms. Key features include adjustable impeller speed, interchangeable screen sizes, and optimized output particle size distribution (PSD).
Test Plan
| Test ID | Procedure | Acceptance | Evidence |
|---|---|---|---|
| IQ-01 | Verify impeller speed | Within specified range | Calibration records |
| IQ-02 | Check screen size | Correct screen installed | Visual inspection |
| IQ-03 | Measure output PSD | Meets specifications | PSD analysis report |
Detailed Test Cases
Test Case IQ-01: Verify Impeller Speed
Procedure: Measure the impeller speed using a tachometer. Ensure it operates within the specified range as per the URS.
Acceptance Criteria: Impeller speed must be within the specified range.
Evidence: Record measurements in the validation log.
Test Case IQ-02: Check Screen Size
Procedure: Inspect the installed screen for correct size and condition. Refer to the equipment specifications.
Acceptance Criteria: The correct screen must be installed and free of damage.
Evidence: Document visual inspection results.
Test Case IQ-03: Measure Output PSD
Procedure: Collect samples of the output and analyze for particle size distribution using appropriate analytical methods.
Acceptance Criteria: Output PSD must meet the specifications outlined in the URS.
Evidence: Include PSD analysis report in the validation documentation.
Deviations
Any deviations from the acceptance criteria must be documented and investigated. Appropriate corrective actions must be taken and documented.
Approvals
Prepared by: [Name] – [Title] – [Date]
Reviewed by: [Name] – [Title] – [Date]
Approved by: [Name] – [Title] – [Date]