Document Control Number: DQ-OSD-001
Version: 1.0
Date: 2023-10-01
Prepared by: [Your Name]
Reviewed by: [Reviewer Name]
Approved by: [Approver Name]
Design Qualification Protocol for Tablet Compression Machine in Solid Dosage Form Production
Meta Description: This document outlines the Design Qualification Protocol for the Tablet Compression Machine used in Solid Dosage Form production, focusing on critical parameters and compliance.
Tags: Equipment Validation, Design Qualification, Tablet Compression, OSD, Production
Objective
The objective of this Design Qualification (DQ) protocol is to ensure that the Tablet Compression Machine (Single Rotary) is properly designed, installed, and operates according to the specified requirements for the production of solid dosage forms.
Scope
This protocol applies to the validation of the Tablet Compression Machine located in the Production/Compression area, impacting the quality of the tablet product directly.
Responsibilities
- Validation Team: Responsible for executing the DQ protocol and documenting results.
- Quality Assurance: Responsible for reviewing and approving the DQ protocol and results.
- Engineering: Responsible for maintaining the equipment and ensuring it meets specifications.
Prerequisites
- Completion of User Requirement Specification (URS).
- Installation Qualification (IQ) completed and approved.
- Staff trained on the operation of the Tablet Compression Machine.
Equipment Description
The Tablet Compression Machine (Single Rotary) is designed for the efficient compression of tablet formulations. It features adjustable speed, compression force, and weight control capabilities, controlled via a PLC (Programmable Logic Controller).
Test Plan
| Test ID | Procedure | Acceptance Criteria | Evidence |
|---|---|---|---|
| DQ-TC-001 | Verify speed settings against specifications. | Speed must be within +/- 10% of set value. | Calibration report. |
| DQ-TC-002 | Check compression force output. | Compression force must meet product specifications. | Force measurement logs. |
| DQ-TC-003 | Verify weight control accuracy. | Weight must be within specified limits. | Weight calibration report. |
Detailed Test Cases
Test Case DQ-TC-001: Speed Verification
Objective: To confirm that the speed settings can be accurately set and maintained.
Procedure: Set the machine to the specified speed and measure the actual speed using a tachometer.
Acceptance Criteria: Speed must be within +/- 10% of set value.
Evidence: Documented calibration report.
Test Case DQ-TC-002: Compression Force Output
Objective: To ensure that the compression force is consistent with product requirements.
Procedure: Run the machine and measure the compression force using a force gauge.
Acceptance Criteria: Compression force must meet product specifications.
Evidence: Force measurement logs.
Test Case DQ-TC-003: Weight Control Accuracy
Objective: To validate the weight control mechanism of the machine.
Procedure: Conduct multiple weight measurements during operation.
Acceptance Criteria: Weight must be within specified limits.
Evidence: Weight calibration report.
Deviations
Any deviations from the acceptance criteria must be documented, along with a justification and corrective actions taken.
Approvals
The completed DQ protocol must be signed and dated by the Validation Team, Quality Assurance, and Engineering representatives upon successful completion of all tests.