Design Qualification Protocol for Oscillating Granulator in Solid Dosage Form
Document Control:
Document Number: DQ-OSD-001
Version: 1.0
Effective Date: [Insert Date]
Review Date: [Insert Date]
Objective
The objective of this Design Qualification (DQ) protocol is to establish documented evidence that the Oscillating Granulator is designed and installed according to the specified requirements for its intended use in the production of solid dosage forms.
Scope
This protocol applies to the Design Qualification of the Oscillating Granulator used in the Production/Milling area for size reduction of wet/dry mass in the manufacturing 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 results.
- Engineering: Responsible for providing technical support and ensuring equipment meets design specifications.
Prerequisites
- Approval of User Requirement Specification (URS).
- Installation of Oscillating Granulator.
- Availability of qualified personnel for testing.
Equipment Description
The Oscillating Granulator is designed for the size reduction of wet and dry mass in the production of solid dosage forms. Key features include adjustable speed settings, various screen sizes, and the capability to produce specific output particle size distributions (PSD).
Test Plan
| Test ID | Procedure | Acceptance Criteria | Evidence |
|---|---|---|---|
| T1 | Verify speed settings | Speed settings match URS specifications | Calibration records |
| T2 | Check screen size | Screen size corresponds to URS requirements | Visual inspection and measurement |
| T3 | Assess output PSD | Output PSD meets URS specifications | Particle size analysis report |
Detailed Test Cases
Test Case T1: Verify Speed Settings
Objective: To confirm that the oscillation speed of the granulator is adjustable and meets specified requirements.
Procedure: Adjust the speed settings to the specified values and record the actual speeds.
Acceptance Criteria: Speed settings must match the specifications outlined in the URS.
Evidence: Documented calibration records showing compliance.
Test Case T2: Check Screen Size
Objective: To ensure the correct screen size is installed on the granulator.
Procedure: Inspect the installed screen and measure its dimensions.
Acceptance Criteria: Screen size must correspond to the requirements in the URS.
Evidence: Visual inspection records and measurement documentation.
Test Case T3: Assess Output PSD
Objective: To verify that the output particle size distribution meets the defined specifications.
Procedure: Collect samples of granulated material and perform particle size analysis.
Acceptance Criteria: Output PSD must comply with the specifications outlined in the URS.
Evidence: Particle size analysis report.
Deviations
Any deviations from the acceptance criteria must be documented and justified. A corrective action plan should be developed and implemented as necessary.
Approvals
Prepared by: [Name] – Validation Team
Reviewed by: [Name] – Quality Assurance
Approved by: [Name] – Engineering