Design Qualification (DQ) is a widely used document in every pharma industry. The DQ is a key input to the commissioning and qualifications as per VMP. After OEM understood the user requirement specification (URS), his team generate the design qualification (DQ) document & submit this to the pharma organization.
This also leads to verification that the proposed design of the facilities, systems, and equipment is suitable for the process and meets all regulatory requirements as per our URS.
After reviewing this design document, we assured that the design deliverables are consistent with the URS and mitigate all control and process strategies. This document is kept & stored by the QA team thought the entire life of that equipment.
Approval of Design Specification:
The protocol is approved by all stakeholders like User, engineering, Quality control warehouse department, etc., and finally approved by the Quality assurance department
Approved By Name: Position: Signature: Date:
Scope: The Design Specification applies to the OEM-supplied machine in accordance with the URS given by the pharmaceutical organization.
This document includes all information and data required for the acceptance test in accordance with the Life Cycle Model (GAMP) or for the Installation Qualification for the hardware and software with all machine components (IQ).
It makes it possible to establish acceptance standards to demonstrate that all client requests are met. To make sure the equipment is installed and commissioned properly
RESPONSIBILITIES:
Pharma Company:
Responsible To Review, Checking, and Approving the design qualification document.
Original Equipment Manufacturer (OEM):
- Design, engineer, and give all technical information necessary for the equipment’s design qualification, i.e.
- Machine overview,
- P&ID drawing,
- Equipment orientation with layout,
- Specifications of the purchased items, including their brand, model, and amount, backup records, and brochures.
- Complete information on Utilities.
- Identification of components for calibration
- Material of construction of all components
- Safety features and alarms
- To assist the client in setting up the machine’s Factory Acceptance Test at their workplace or location.
- To make sure the item was safely delivered to the user site.
- To ensure that there won’t be any unapproved or undocumented design changes.
- If a change to the mutually agreed-upon design is ever desired, the change control method must be followed and documented.
Object, Purpose, and Execution:
Design Qualification is a very important part of VMP. It provides the documented verification of the design of new or modified equipment and captures all direct or indirect impacts on the product.
DQ verifies that the machine is adequate to control the risks to product quality and personal safety. Also, a guide about the mitigation of risk that is identified during the Quality Risk Assessment (QRA) is present in the design.
- Machine description.
- Component details
- Instrumentation details
- loading & unloading of material
- Equipment subassemblies & parts
- Description of the Main body of the machine
- ON/OFF valve details
- Product containers or product direct contact part details
- Control panel & power panel
- Control system, field instruments, etc.
- Technical specification
- Material of construction
- Enclosures
- Utility specification
- Safety features
- Fat procedure:
- Change control procedure
DQ will be executed during the development of the concept and the Basis of Design packages and near the completion of the detailed design.
At every stage, there could be a reiteration of the URS which is used to develop as per information gathered from various sources such as process development, the introduction of better technology/solutions from vendor offerings, etc.
Final Approval:
Finally, DQ will evaluate and approved by all stakeholders,
- Technical SMEs,
- System owners,
- Any other stakeholders
- The document was finally approved by the Quality Head
FAQ Regarding Design Qualification:
Answer: DQ contains all the design aspects of the engineering machine-like automation, size, capacity, outputs, GA drawings, Electrical drawings etc. This is the base document for any equipment as per engineering aspects.
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