登录查看更多内容

What are the most effective design control methods for combination products?

由人工智能和领英社区提供技术支持

Combination products are medical devices that integrate drugs, biologics, or both, to provide a therapeutic effect. They pose unique challenges for engineering design, as they require compliance with different regulatory standards and quality systems. To ensure safety and effectiveness, combination products need to undergo rigorous design control methods that address the interactions and compatibility of the components, the performance and reliability of the product, and the user needs and expectations. In this article, you will learn about some of the most effective design control methods for combination products, and how they can help you meet the requirements and expectations of your stakeholders.

此文章中的业界达人

由社区从 5 条内容中精选。了解更多

PERVEZ A.

Research Assistant Project Air Pollution Indian Institute of Technology (Banaras Hindu University) Varanasi

1 User-centered design

User-centered design (UCD) is a design approach that focuses on understanding and satisfying the needs, preferences, and limitations of the end users of a product. UCD involves engaging users throughout the design process, from identifying the problem and defining the requirements, to testing and evaluating the prototypes and final product. UCD can help you design combination products that are safe, effective, user-friendly, and compliant with the intended use and labeling. UCD can also help you avoid costly design changes, user errors, and adverse events that may arise from poor usability or human factors.

添加您的观点

PERVEZ A.

Research Assistant Project Air Pollution Indian Institute of Technology (Banaras Hindu University) Varanasi
举报内容
Combination products, with their unique blend of drug and device elements, demand specific design control approaches to ensure safety and effectiveness. Here are some of the most effective methods: Strong Quality Management System (QMS): Establish a robust QMS aligned with relevant regulations like 21 CFR Part 4 and applicable drug and device guidelines. Ensure top-level commitment to quality and prioritize risk management throughout the lifecycle. Implement clear procedures for design control activities, including documentation, change control, nonconformance management, and CAPA processes.

已翻译

赞

2 Design of experiments

Design of experiments (DOE) is a statistical method that allows you to systematically test and optimize multiple variables and factors that affect the performance and quality of a product. DOE can help you design combination products that are robust, reliable, and consistent, and that meet the specifications and acceptance criteria. DOE can also help you reduce the number of experiments, save time and resources, and identify the optimal settings and interactions of the variables. DOE can be applied to various stages of the design process, such as screening, optimization, validation, and verification.

添加您的观点

PERVEZ A.

Research Assistant Project Air Pollution Indian Institute of Technology (Banaras Hindu University) Varanasi
举报内容
Risk Management: Conduct comprehensive risk assessments considering both individual components and their interactions within the final product. Leverage established frameworks like ISO 14971 (for devices) and ICH Q9 (for drugs) to identify, analyze, and control hazards across the product lifecycle. Apply risk-based design decisions, prioritizing controls for significant risks. Streamlined Design Control Approach: Identify the "base system" for design controls: Drug GMP for drug-dominant products or Device QSR for device-dominant ones. Comply with all applicable requirements for this base system. Adopt additional provisions from the other system as needed to ensure comprehensive coverage.

已翻译

赞

3 Failure mode and effects analysis

Failure mode and effects analysis (FMEA) is a risk management tool that helps you identify and prioritize the potential failures and their causes and effects on a product or process. FMEA can help you design combination products that are safe and effective, and that minimize the likelihood and severity of failures. FMEA can also help you implement preventive and corrective actions, monitor and control the risks, and document the results and actions. FMEA can be conducted at different levels of detail and complexity, such as system, design, process, or use.

添加您的观点

PERVEZ A.

Research Assistant Project Air Pollution Indian Institute of Technology (Banaras Hindu University) Varanasi
举报内容
Refer to FDA "Guidance on CGMP for Combination Products" for detailed information on streamlining. Collaboration and Interface Management: Establish clear communication channels between cross-functional teams (drug, device, packaging, etc.) involved in design. Define clear interfaces between components and systems, including physical, chemical, and functional interactions. Implement procedures for resolving interface-related issues and ensuring compatibility.

已翻译

赞

4 Quality function deployment

Quality function deployment (QFD) is a planning tool that helps you translate the voice of the customer (VOC) into measurable design requirements and specifications. QFD can help you design combination products that meet or exceed the customer expectations and satisfaction, and that align with the business goals and strategies. QFD can also help you communicate and coordinate the design requirements and specifications across different functions and departments, such as engineering, manufacturing, marketing, and regulatory. QFD can be implemented using various matrices, such as the house of quality (HOQ), that link the VOC to the design features and characteristics.

添加您的观点

PERVEZ A.

Research Assistant Project Air Pollution Indian Institute of Technology (Banaras Hindu University) Varanasi
举报内容
Design Verification and Validation (V&V): Conduct thorough V&V activities to ensure the design meets its intended functions and specifications. Tailor V&V plans to the specific risks and complexities of the combination product. Utilize various V&V methods like testing, analysis, and modeling. Additional Effective Methods: Employ Design for Manufacturing and Assembly (DFMA) principles to optimize production and minimize errors. Implement robust supplier qualification and control programs for components and materials.

已翻译

赞

5 Design review

Design review is a formal and structured process that involves evaluating and verifying the design outputs and outcomes against the design inputs and objectives. Design review can help you design combination products that are compliant with the regulatory standards and quality systems, and that demonstrate the safety and effectiveness of the product. Design review can also help you identify and resolve any design issues, gaps, or discrepancies, and provide feedback and recommendations for improvement. Design review can be performed at various stages and milestones of the design process, such as conceptual, preliminary, critical, and final.

添加您的观点

PERVEZ A.

Research Assistant Project Air Pollution Indian Institute of Technology (Banaras Hindu University) Varanasi
举报内容
Utilize design reviews and audits conducted by qualified personnel at key stages. Maintain thorough design documentation throughout the product lifecycle. Remember, the specific design control methods you choose will depend on your unique product, its risks, and your regulatory requirements. Consulting with experts in both drug and device development is crucial for implementing effective and compliant design controls for your combination product.

已翻译

赞

6 Here’s what else to consider

This is a space to share examples, stories, or insights that don’t fit into any of the previous sections. What else would you like to add?

添加您的观点

Engineering Design

+ 关注

给文章评分

我们借助人工智能创建了此文章。您认为这篇文章怎么样？

很棒不太好

举报此文章

查看全部

What are the most effective design control methods for combination products?

1

2

3

4

5

6

1 User-centered design

2 Design of experiments

3 Failure mode and effects analysis

4 Quality function deployment

5 Design review

6 Here’s what else to consider

Engineering Design

给文章评分

感谢您的反馈

更多Engineering Design相关文章

更多相关阅读内容

What are the most effective design control methods for combination products?

1

2

3

4

5

6

1 User-centered design

2 Design of experiments

3 Failure mode and effects analysis

4 Quality function deployment

5 Design review

6 Here’s what else to consider

Engineering Design

给文章评分

感谢您的反馈

查看其他技能