Design Qualification Protocol for Pin Mill in Solid Dosage Form Production
Document Number: DQ-PM-001
Version: 1.0
Effective Date: 2023-10-01
Reviewed By: [Name]
Approval Date: [Date]
Objective
The objective of this Design Qualification (DQ) Protocol is to establish documented evidence that the Pin Mill equipment is suitable for its intended use in the fine milling of solid dosage forms, ensuring compliance with user requirements and regulatory standards.
Scope
This protocol applies to the Pin Mill utilized in the Production/Milling area for fine milling processes impacting the quality of solid dosage forms.
Responsibilities
- Validation Team: Responsible for the execution and documentation of the DQ protocol.
- Quality Assurance: Responsible for reviewing and approving the DQ protocol and all associated documentation.
- Production Team: Responsible for the operation of the Pin Mill and adherence to the established procedures.
Prerequisites
- Completion of User Requirements Specification (URS).
- Installation Qualification (IQ) completed and approved.
- Operational Qualification (OQ) protocols prepared.
Equipment Description
The Pin Mill is a milling device used for fine milling of solid dosage forms. It operates by utilizing high-speed rotating discs to achieve the desired particle size distribution (PSD). The critical parameters for this equipment include disc speed, output particle size distribution (PSD), and temperature.
Test Plan
| Test ID | Procedure | Acceptance Criteria | Evidence |
|---|---|---|---|
| DQ-01 | Verify disc speed settings | Disc speed within specified range as per URS | Calibration records |
| DQ-02 | Measure output PSD | Output PSD meets specifications outlined in URS | Particle size analysis report |
| DQ-03 | Monitor milling temperature | Temperature remains within specified limits | Temperature log |
Detailed Test Cases
Test Case DQ-01: Verify Disc Speed Settings
- Procedure: Set the disc speed to the required setting and verify using a calibrated tachometer.
- Acceptance Criteria: Disc speed must be within the range specified in the URS.
- Evidence: Record of tachometer readings and calibration certificate.
Test Case DQ-02: Measure Output PSD
- Procedure: Collect samples post-milling and analyze using laser diffraction.
- Acceptance Criteria: The output PSD must conform to the specifications outlined in the URS.
- Evidence: Particle size analysis report.
Test Case DQ-03: Monitor Milling Temperature
- Procedure: Continuously monitor and log temperature during milling operations.
- Acceptance Criteria: Temperature must remain within the limits specified in the URS.
- Evidence: Temperature log and monitoring records.
Deviations
Any deviations from the acceptance criteria must be documented and reviewed by the validation team and Quality Assurance. A root cause analysis should be conducted, and corrective actions must be implemented.
Approvals
By signing below, the undersigned approve this Design Qualification Protocol:
__________________________ Validation Team Lead
__________________________ Quality Assurance
__________________________ Production Manager