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Document Number: DQ-OSD-FC-001
Version: 1.0
Effective Date: [Insert Date]
Review Date: [Insert Date]
Prepared By: [Insert Name]
Approved By: [Insert Name]
Design Qualification Protocol for Flake Crusher in Solid Dosage Form Production
Meta Description: This document outlines the Design Qualification Protocol for the Flake Crusher used in Solid Dosage Form production, detailing objectives, scope, responsibilities, and test plans.
Objective
The objective of this Design Qualification (DQ) protocol is to ensure that the Flake Crusher operates according to specified requirements and is suitable for its intended use in the production of solid dosage forms.
Scope
This protocol applies to the Flake Crusher used in the production area for dry granulation processes, specifically for crushing ribbons/flakes into smaller particles.
Responsibilities
The validation team is responsible for executing this protocol and ensuring compliance with all acceptance criteria. The Quality Assurance team will review and approve the results.
Prerequisites
1. Installation of the Flake Crusher in the designated production area.
2. Completion of the User Requirement Specification (URS).
3. Availability of qualified personnel for testing.
Equipment Description
The Flake Crusher is designed to crush ribbons/flakes generated from the roller compaction process into a specified particle size distribution (PSD). Key parameters include speed and screen output PSD.
Test Plan
| Test ID | Procedure | Acceptance Criteria | Evidence |
|---|---|---|---|
| T1 | Verify speed settings | Speed within specified range | Calibration records |
| T2 | Measure screen output PSD | PSD meets URS requirements | Particle size analysis report |
Detailed Test Cases
Test Case 1: Verify Speed Settings
Procedure: Set the Flake Crusher to the specified speed and record the actual speed using a calibrated tachometer.
Acceptance Criteria: The recorded speed must be within the range specified in the URS.
Evidence: Calibration records and speed measurement logs.
Test Case 2: Measure Screen Output PSD
Procedure: Collect samples of crushed material and analyze particle size distribution using appropriate analytical methods.
Acceptance Criteria: The PSD must meet the specifications outlined in the URS.
Evidence: Particle size analysis report.
Deviations
Any deviations from the acceptance criteria must be documented and investigated. A corrective action plan should be developed and implemented as necessary.
Approvals
This protocol must be reviewed and approved by the Quality Assurance team before execution.