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How can GMP improve pharmaceutical product design?

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Pharmaceutical product design is a complex and multidisciplinary process that involves not only scientific and technical aspects, but also regulatory, ethical, and user-centered considerations. One of the key factors that can affect the quality, safety, and efficacy of pharmaceutical products is the adherence to good manufacturing practices (GMP). GMP are guidelines that ensure that products are consistently produced and controlled according to the highest standards. In this article, we will explore how GMP can improve pharmaceutical product design from different perspectives.

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Irfan Ali Mohammed, MS

I lead CMC Drug Development from Pre-Clinical to Commercialization | Strategy and Operations | Injectables…

1 GMP and product development

GMP can help pharmaceutical product designers to plan, execute, and document the product development process in a systematic and transparent way. By following GMP, designers can ensure that the product specifications, design inputs, and design outputs are aligned with the intended use, performance, and safety of the product. GMP can also facilitate the verification and validation of the product design, as well as the risk management and change control activities.

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Irfan Ali Mohammed, MS

I lead CMC Drug Development from Pre-Clinical to Commercialization | Strategy and Operations | Injectables, Ophthalmics, Oral Solids | Combination Products
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All bio/pharmaceutical products are expected to be manufactured under cGMP following Quality-by-Design (QbD) principles. Bio/Pharmaceutical product design and development should also start by following QbD principles to ensure Quality is embedded from the ideation stage. Similarly, it is absolutely crucial for product development scientists and engineers to engage and collaborate with manufacturing/ technical operations team to learn and understand the GMP manufacturing process flow, material, equipment and personnel flow. Working backwards: Understand your manufacturing capabilities --> assess and fill gaps --> design and develop a robust product and process that can be implemented and scaled.

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2 GMP and user experience

GMP can also enhance the user experience of pharmaceutical products by ensuring that the design meets the needs, preferences, and expectations of the end users. By applying GMP, designers can conduct user research, testing, and feedback throughout the product design process, and incorporate user-centered design principles and methods. GMP can also help designers to create products that are easy to use, understand, and access, and that provide clear and accurate information and instructions.

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3 GMP and innovation

GMP can also foster innovation in pharmaceutical product design by encouraging designers to adopt a creative and iterative approach to solve problems and generate solutions. By following GMP, designers can explore different possibilities, test different prototypes, and learn from failures and successes. GMP can also support designers to collaborate with other disciplines and stakeholders, and to leverage new technologies and trends that can improve the functionality, usability, and aesthetics of the products.

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4 GMP and sustainability

GMP can also contribute to the sustainability of pharmaceutical product design by promoting the efficient use of resources, the minimization of waste, and the prevention of environmental impacts. By applying GMP, designers can consider the life cycle of the products, from the raw materials to the disposal, and implement strategies to reduce the environmental footprint. GMP can also help designers to create products that are durable, reusable, recyclable, and biodegradable.

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5 GMP and compliance

GMP can also ensure that pharmaceutical product design complies with the relevant laws, regulations, and standards that apply to the industry. By following GMP, designers can demonstrate that the products are safe, effective, and quality-assured, and that they meet the requirements of the authorities and the customers. GMP can also help designers to prepare and maintain the necessary documentation, records, and evidence that support the product design process and outcomes.

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6 GMP and competitiveness

GMP can also improve the competitiveness of pharmaceutical product design by enhancing the reputation, trust, and loyalty of the customers and the market. By following GMP, designers can deliver products that are reliable, consistent, and satisfactory, and that meet or exceed the expectations of the users. GMP can also help designers to differentiate their products from the competitors, and to create value and benefits for the customers and the society.

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7 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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Irfan Ali Mohammed, MS

I lead CMC Drug Development from Pre-Clinical to Commercialization | Strategy and Operations | Injectables, Ophthalmics, Oral Solids | Combination Products
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Based on my learnings (still on-going) and experiences, a product development scientist or engineer should start by understanding how their product will be manufactured. Take those learnings back to the laboratory to design and develop a robust product and process that can be efficiently transferred to the manufacturing floor, implemented and scaled. Collaborate with the manufacutring team, educate them about the product, process and significance of the specifications. If a product requires new capability introduction in GMP manufacturing, the learnings will help plan proactively as the technical team installs (IQ, OQ, PQ) the new equipment. All these are examples of cross-functional collaboration, team work, and leadership.

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How can GMP improve pharmaceutical product design?

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3

4

5

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1 GMP and product development

2 GMP and user experience

3 GMP and innovation

4 GMP and sustainability

5 GMP and compliance

6 GMP and competitiveness

7 Here’s what else to consider

Industrial Design

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How can GMP improve pharmaceutical product design?

1

2

3

4

5

6

7

1 GMP and product development

2 GMP and user experience

3 GMP and innovation

4 GMP and sustainability

5 GMP and compliance

6 GMP and competitiveness

7 Here’s what else to consider

Industrial Design

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