Disintegration test apparatus is used to check the disintegration of the tablets and capsules in the required period of time. Apparatus consists of one or two (based on URS) basket assembly each having 6 tubes of specified diameter in which the tablets or capsules have been inserted to check the DT. Design Qualification of DT Apparatus is done after finalising the URS FAT and SAT.
OBJECTIVE FOR DESIGN QUALIFICATION OF DT APPARATUS
To verify and document that the design of the Disintegration Test Apparatus is suitable for its intended purpose and complies with User Requirement Specifications (URS), applicable regulatory requirements, GMP guidelines, and operational needs prior to installation and commissioning.
SCOPE
This Design Qualification protocol covers the review and verification of the design, technical specifications, safety features, utilities, instrumentation, and documentation of the Disintegration Test Apparatus.
This qualification is applicable to the Disintegration Test Apparatus to be installed at XYZ Company
REFERENCES
- User Requirement Specification (URS)
- Equipment Technical Specification
- Vendor Drawings and Manuals
- Good Manufacturing Practices (GMP)
- Applicable IP/USP Requirements
- Company Validation Master Plan (VMP)
PRE-APPROVAL OF DOCUMENT
Prepared By
| Designation | Name | Date | Signature |
| Executive/Officer Engineering |
Reviewed By
| Designation | Name | Date | Signature |
| Head Engineering | |||
| Head Production |
Approved By
| Designation | Name | Date | Signature |
| Head QA |
RESPONSIBILITIES
Customer Responsibilities
- Provide approved User Requirement Specifications (URS).
- Review and approve technical specifications and drawings.
- Participate in design review activities.
- Approve Design Qualification documentation.
Manufacturer Responsibilities
- Design and manufacture equipment in accordance with approved specifications.
- Provide complete technical documentation and drawings.
- Ensure compliance with applicable quality and safety requirements.
- Notify the customer of any proposed design changes through a documented change control system.
- Ensure safe transportation and delivery of equipment.
DESIGN REVIEW CRITERIA
The Design Qualification shall verify:
- Compliance of equipment design with URS.
- Compliance with IP/USP requirements.
- Adequacy of construction materials.
- Suitability of utilities and electrical requirements.
- Adequacy of instrumentation and controls.
- Operator and product safety provisions.
- Availability of calibration and maintenance provisions.
- Availability of technical documentation.
EQUIPMENT DESCRIPTION
The Disintegration Test Apparatus is designed for determining the disintegration time of tablets and capsules in accordance with IP/USP requirements.
The apparatus consists of two independent basket assemblies, each capable of testing six tablets simultaneously. Independent timers and drive mechanisms are provided for each basket assembly. Temperature and test duration are displayed digitally. At completion of the test cycle, baskets automatically return to the upper position.
TECHNICAL SPECIFICATIONS FOR DESIGN QUALIFICATION OF DT APPARATUS
| Parameter | Specification |
| Equipment Name | Disintegration Test Apparatus |
| Make | |
| Model No. | |
| Power Supply | |
| Frequency | |
| Dimensions | |
| Protection Class | |
| Operating Temperature Range | |
| Number of Test Stations | |
| Compliance Standard | USP Chapter 701 |
SAFETY FEATURES
| Safety Feature | Purpose |
| Electrical Insulation | Protection against electrical shock |
| Earthing System | Personnel safety and equipment protection |
| Overload Protection | Protection of electrical components |
| Emergency Shut-off (if applicable) | Safe equipment shutdown |
UTILITIES REQUIREMENT
| Utility | Requirement |
| Electrical Supply | |
| Voltage | |
| Frequency | |
| Power Consumption |
EQUIPMENT CONSTRUCTION DETAILS DURING DESIGN QUALIFICATION OF DT APPARATUS
Equipment Structure
| Description | Specification | Verification Method | Actual Observation | Checked By |
| Make/Model | ||||
| Construction Material | ||||
| Surface Finish |
INSTRUMENTS REQUIRING CALIBRATION
| Instrument | Location | Model No. | Serial No. | Calibration Required |
| Voltmeter | Operating Panel | Yes | ||
| Ammeter | Operating Panel | Yes | ||
| Temperature Sensor | Test Chamber | Yes | ||
| Timer | Operating Panel | Yes |
DOCUMENTS REVIEWED DURING DESIGN QUALIFICATION OF DT APPARATUS
| Document Name | Document Number | Status |
| Technical Datasheet | ||
| GA Drawing | ||
| Electrical Drawing | ||
| Operation Manual | ||
| Calibration Certificates |
DESIGN QUALIFICATION SUMMARY
Based on the review of equipment design, technical specifications, safety features, utilities, instrumentation, and supporting documentation, the Disintegration Test Apparatus is found to be suitable for its intended use and complies with specified user requirements.
DEVIATION (IF ANY)
| Sr. No. | Description of Deviation | Corrective Action | Status |
CONCLUSION
The Design Qualification of the Disintegration Test Apparatus has been completed satisfactorily. The equipment design is acceptable and recommended for Installation Qualification (IQ).
FINAL APPROVAL
| Department | Name | Signature | Date |
| Engineering | |||
| Production | |||
| Quality Assurance |
FAQ’s FOR DESIGN QUALIFICATION OF DT APPARATUS
Q-1 What is DQ
Answer:- DQ is defined as Design Qualification. It is the part of Qualification. Design qualification is documented verification to demonstrate the proposed design of equipment, facility, system and utility for its intended purpose.
Q-2 Why DQ is Important?
Answer:- DQ helps and identify whether the design will meet operational needs and as per regulatory requirements.
Q-3 When should DQ performed ?
Answer:- DQ should be performed before the equipment purchased and after SAT in the facility. Design review should be performed after URS.
Q-4 What documents are reviewed during DQ ?
Answer:- User Requirement Specification
Functional Specification
Design Review document
Process Flow Diagram
Piping & Instrumentation Diagram
General drawings of Equipments
Q-5 What happens if any gaps are identified during DQ?
Answer:- The found gaps are identified and documented. Suitable CAPA taken, updation in existing design document before proceed to next stage.