How can you use DOE to design GMP products?

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Design of experiments (DOE) is a powerful tool for optimizing products and processes in various industries, including those that follow good manufacturing practice (GMP) standards. GMP is a system of guidelines and regulations that ensure the quality, safety, and efficacy of products that are intended for human or animal use, such as pharmaceuticals, biologics, medical devices, cosmetics, and food. In this article, you will learn how you can use DOE to design GMP products that meet your specifications, customer expectations, and regulatory requirements.

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Billgerd Tjengal

Analytical Development Scientist at PT. KIMIA FARMA, TBK
Juan Valdez, CLSSBB

Senior Executive in Manufacturing & Product Development | Lean Six Sigma Black Belt | Innovator Driving Operational…
Dapo Odunlade

Validation Lead at ADM

1 What is DOE?

DOE is a method of planning, conducting, and analyzing experiments that allows you to test multiple factors and their interactions simultaneously. By using DOE, you can identify the optimal combination of factors that affect your product performance, such as ingredients, formulation, process parameters, equipment settings, and environmental conditions. DOE also helps you to reduce the number of experiments needed, saving time, money, and resources.

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Dapo Odunlade

Validation Lead at ADM
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One thing, I've found useful with factorial design is the ability to predict the effect of multiple parameter changes on Quality attribute.

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Billgerd Tjengal

Analytical Development Scientist at PT. KIMIA FARMA, TBK
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DoE (Design of Experiment) is basically a statistical method that we use to identify significant factors, and the optimal combination of those factors that affect the product quality. Let's say you want to make a popcorn using microwave oven. You want to know what affect / optimize the amount of unpopped popcorn from those parameters: duration, amount of popcorn, position of the popcorn, etc. Using DoE you can distinguish what to optimize.

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2 Why use DOE for GMP products?

GMP products are subject to strict quality control and validation procedures that ensure their consistency, reliability, and compliance with the applicable standards and regulations. However, these procedures can also be costly, time-consuming, and complex, especially when you need to make changes or improvements to your product or process. By using DOE, you can design GMP products that are robust, stable, and scalable, and that can withstand variations in the manufacturing process and the external environment. DOE also helps you to document and justify your design decisions, which can facilitate the approval and audit processes.

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Billgerd Tjengal

Analytical Development Scientist at PT. KIMIA FARMA, TBK
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GMP Products such as pharmaceuticals, and foods needs to be stable, and consistent. For generic pharmaceutical products needs to be bioequivalent. Using DoE you can easily optimize the amount of additives (or excipients) such as disintegrant, colorant, preservative, etc that may or may not impact product performance; in order to get the final specifications that you want.

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3 How to use DOE for GMP products?

Using DOE for GMP products follows similar steps to other product or process optimization, yet there are some special aspects to consider. You must define your objective and scope, such as the quality attributes, acceptance criteria, controllable factors, and any constraints or limitations. Selecting an experimental design includes determining the type of DOE, number of factors and levels, number of runs or trials, randomization or blocking methods, and data validation and reliability. Conducting experiments includes preparing and executing them, measuring and recording responses or outcomes, handling deviations or errors, and following GMP protocols and documentation requirements. Analyzing results involves using statistical tools and software to interpret and visualize data, identify main effects and interactions of factors, and determine optimal settings or conditions for the product or process. Lastly, verifying and validating findings requires confirming and testing them against specifications or expectations, evaluating robustness and stability of the product or process, and documenting and reporting findings with recommendations.

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4 What are the benefits of using DOE for GMP products?

Using DOE for GMP products can bring you several benefits, such as improving product quality, safety, and efficacy; enhancing customer satisfaction and loyalty; reducing costs and risks; increasing productivity and efficiency; supporting decision making and problem solving; and facilitating compliance and auditability. Optimizing critical factors and minimizing variability and uncertainty can help you meet or exceed customer expectations and needs, saving time, money, and resources while avoiding rework, waste, and defects. Moreover, DOE can provide data-driven insights and evidence to streamline processes and eliminate unnecessary steps or activities. Finally, it can document and justify design choices and actions to support auditability.

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Billgerd Tjengal

Analytical Development Scientist at PT. KIMIA FARMA, TBK
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There are a lot of benefits (and of course disadvantages) of using DoE. The benefits are: It may help a lot in the development of difficult projects. Reducing the amount of trials. In other hand, if you choose to use DoE on a project that is not that hard, you may waste time and resources optimizing a parameter that can already be predicted using theoretical aspect.

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5 What are the challenges of using DOE for GMP products?

Using DOE for GMP products can also pose some challenges, such as defining your objective and scope clearly and realistically, while considering your business goals and customer requirements. The experimental design should be selected with care to balance the trade-offs between complexity, accuracy, and feasibility. Experiments should be conducted carefully and consistently, following GMP rules and regulations. Results should be analyzed correctly and objectively to avoid any bias or errors. Finally, findings should be verified and validated thoroughly and rigorously, addressing any gaps or discrepancies.

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Juan Valdez, CLSSBB

Senior Executive in Manufacturing & Product Development | Lean Six Sigma Black Belt | Innovator Driving Operational Excellence | Industry 4.0 Leader | Strategic Business Development Expert
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Design of Experiments (DOE) requires managing numerous variables and their interactions, which adds significant complexity to the experimental process. Each factor, whether it’s a variable in formulation, process conditions, or material properties, can influence the outcome. Understanding how these factors interact, both independently and in combination, is critical for accurate analysis. This complexity demands advanced statistical and experimental design skills to develop robust experimental plans. Additionally, sophisticated software tools are often needed to model these interactions and interpret the results effectively.

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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 use DOE to design GMP products?

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1 What is DOE?

2 Why use DOE for GMP products?

3 How to use DOE for GMP products?

4 What are the benefits of using DOE for GMP products?

5 What are the challenges of using DOE for GMP products?

6 Here’s what else to consider

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