Document Control Number: DQ-ACM-001
Version: 1.0
Effective Date: [Insert Date]
Reviewed By: [Insert Name]
Approval Date: [Insert Date]
Design Qualification Protocol for Air Classifier Mill in Solid Dosage Form Production
Meta Description: This document outlines the Design Qualification Protocol for the Air Classifier Mill used in the production of Solid Dosage Forms, ensuring compliance with critical parameters and acceptance criteria.
Tags: Equipment Validation, Design Qualification, Air Classifier Mill, Solid Dosage Form
Objective
The objective of this Design Qualification (DQ) protocol is to verify that the Air Classifier Mill meets the established requirements for its intended use in the production of Solid Dosage Forms, ensuring compliance with critical parameters and acceptance criteria as defined in the User Requirement Specification (URS).
Scope
This DQ protocol applies to the Air Classifier Mill utilized in the Production/Milling area for controlled fine milling of solid dosage forms. It encompasses the verification of equipment performance, operational capabilities, and adherence to regulatory standards.
Responsibilities
The responsibilities for this DQ protocol are as follows:
- Validation Team: Responsible for executing the DQ protocol and documenting results.
- Quality Assurance: Responsible for reviewing and approving the DQ documentation.
- Production Team: Responsible for providing operational insights and supporting validation activities.
Prerequisites
- Completion of installation qualification (IQ).
- Availability of User Requirement Specification (URS).
- Training of personnel on equipment operation.
Equipment Description
The Air Classifier Mill is designed for controlled fine milling of solid dosage forms. It utilizes classifier speed, airflow, and particle size distribution (PSD) to achieve desired milling outcomes. The equipment is critical for ensuring uniformity and quality in product formulation.
Test Plan
| Test ID | Procedure | Acceptance Criteria | Evidence |
|---|---|---|---|
| T1 | Verify classifier speed settings | Within specified range as per URS | Calibration report |
| T2 | Measure airflow rates | Within specified range as per URS | Flow rate measurement log |
| T3 | Assess particle size distribution (PSD) | Meets specifications outlined in URS | PSD analysis report |
Detailed Test Cases
Test Case 1: Classifier Speed Verification
Objective: To ensure that the classifier speed is set within the specified range.
Procedure: Adjust the classifier speed and record the settings. Compare with URS requirements.
Acceptance: Classifier speed must be within the specified range.
Evidence: Calibration report documenting speed settings.
Test Case 2: Airflow Rate Measurement
Objective: To verify that the airflow rate meets the specified requirements.
Procedure: Measure airflow using calibrated flow meters during operation.
Acceptance: Airflow must be within the specified range as per URS.
Evidence: Flow rate measurement log.
Test Case 3: Particle Size Distribution Assessment
Objective: To confirm that the PSD of milled product meets specifications.
Procedure: Collect samples and analyze using appropriate methods.
Acceptance: PSD must meet the specifications outlined in the URS.
Evidence: PSD analysis report.
Deviations
Any deviations from the established acceptance criteria must be documented and assessed for impact on product quality. Appropriate corrective actions should be taken as necessary.
Approvals
Approved by: ______________________
Date: ______________________