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How can you ensure GMP design control and validation requirements are met for new or emerging technologies?

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Designing new or emerging technologies can be exciting and rewarding, but also challenging and complex. You need to ensure that your products meet the quality, safety, and performance standards required by the Good Manufacturing Practice (GMP) regulations. How can you apply the GMP design control and validation principles to your innovation process? Here are some tips to help you.

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1 Understand the regulations

Before you start designing, you need to familiarize yourself with the relevant GMP regulations for your industry and market. These may vary depending on the type, function, and intended use of your product. For example, medical devices, pharmaceuticals, and biotechnology products may have different GMP requirements than food, cosmetics, or electronics. You also need to consider the regulatory agencies and authorities that will review and approve your product, such as the FDA, EMA, or TGA. You should consult with them early and often to ensure that you comply with their expectations and guidelines.

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Andrew McGillivray

Director of Food Safety and Quality Assurance at Redbarn Pet Products
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Be real. When you read that an organization is using a cross functional team to assess something new or different that is usually BS. Organizations have an individual that writes/maintains HACCP, probably the same tired soul that is responsible for their other programs too (GFSI, ISO, Regulatory claim programs). So, from my POV, an objective strong, proven, trusted person can do a lot. This person already knows that aspects of programs that are already in place that guide them through "New". Think change management, HACCP asssement, program review, etc. Someone in the comments said risk analysis (bingo). But not too many folks know how to do a risk analysis, confidence measurement, degree of certainty of consequence scores. And more

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2 Define the design inputs and outputs

The GMP design control process starts with defining the design inputs, which are the requirements and specifications that your product must meet. These may include customer needs, user feedback, market research, technical standards, regulatory criteria, and risk analysis. You should document and verify the design inputs clearly and comprehensively. Next, you need to define the design outputs, which are the results and deliverables of your design activities. These may include drawings, models, prototypes, test plans, and reports. You should document and validate the design outputs against the design inputs to ensure that they meet the requirements and specifications.

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Keval Pednekar

Quality Assurance Auditor
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In my experience to ensure GMP design control and validation requirements are met for new or emerging technologies, thorough risk assessments and feasibility studies are conducted. Collaboration between cross-functional teams aids in identifying potential risks and establishing appropriate controls early in the design process. Prototyping and simulation techniques help validate the technology's performance and reliability. Additionally, continuous monitoring and adaptation throughout the development lifecycle ensure compliance with evolving regulatory standards.

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3 Follow the design stages and reviews

The GMP design control process follows a series of stages and reviews that guide you from the concept to the final product. These may include feasibility, development, verification, validation, transfer, and changes. At each stage, you need to perform and document the appropriate design activities, such as research, analysis, testing, evaluation, and improvement. You also need to conduct and document the periodic design reviews, which are formal and systematic assessments of the design outputs by a qualified and independent team. The design reviews help you to identify and resolve any issues, gaps, or errors in your design process and product.

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4 Implement the design changes and traceability

The GMP design control process allows you to make changes to your design inputs or outputs as needed, but you need to follow a rigorous and controlled procedure. You need to document and justify the reasons for the changes, as well as the impact and consequences of the changes on the product quality, safety, and performance. You also need to verify and validate the changes to ensure that they meet the requirements and specifications. Moreover, you need to implement and maintain the design traceability, which is the ability to link and track the design inputs and outputs throughout the design process and product lifecycle. The design traceability helps you to ensure the consistency, completeness, and compliance of your design process and product.

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5 Monitor and improve the design process

The GMP design control process is not a one-time event, but a continuous and iterative process that requires constant monitoring and improvement. You need to collect and analyze the data and feedback from your design activities, as well as from the manufacturing, distribution, and post-market surveillance of your product. You need to use the data and feedback to evaluate the effectiveness and efficiency of your design process and product, as well as to identify and implement any opportunities for improvement. You also need to update and revise your design documentation and records accordingly.

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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?

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How can you ensure GMP design control and validation requirements are met for new or emerging technologies?

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2

3

4

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1 Understand the regulations

2 Define the design inputs and outputs

3 Follow the design stages and reviews

4 Implement the design changes and traceability

5 Monitor and improve the design process

6 Here’s what else to consider

Industrial Design

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How can you ensure GMP design control and validation requirements are met for new or emerging technologies?

1

2

3

4

5

6

1 Understand the regulations

2 Define the design inputs and outputs

3 Follow the design stages and reviews

4 Implement the design changes and traceability

5 Monitor and improve the design process

6 Here’s what else to consider

Industrial Design

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