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How can you design a GMP process that adapts to changing customer needs?

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Designing a GMP process that adapts to changing customer needs is a challenge for any industrial designer. GMP stands for good manufacturing practice, and it is a set of standards and guidelines that ensure the quality and safety of products in regulated industries, such as pharmaceuticals, medical devices, food, and cosmetics. A GMP process involves design control and validation, which are systematic methods to plan, document, test, and verify that a product meets its intended specifications and user needs. However, customer needs are not static, and they may change over time due to market trends, feedback, regulations, or innovations. How can you design a GMP process that is flexible enough to accommodate these changes without compromising quality and compliance? Here are some tips to help you achieve this goal.

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Jorge W. Rivas Tovar

Technical Operations Director / Plant Director / Plant General Manager

1 Define clear and measurable requirements

One of the first steps in designing a GMP process is to define the requirements of the product and the process. These requirements should be based on the customer needs, the regulatory standards, and the technical feasibility. They should also be clear, measurable, and testable, so that you can verify and validate them throughout the design and development stages. By having clear and measurable requirements, you can avoid ambiguity, confusion, and errors that may lead to rework, delays, or nonconformities.

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Jorge W. Rivas Tovar

Technical Operations Director / Plant Director / Plant General Manager
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Los requisitos de GMPs deben venir acompa?ados del ciclo de vida del producto. Algunos criterios GMPs se vuelven más estrictos en el tiempo y la regulación misma avanza conforme la técnica y tecnología se van desarrollando. Sin embargo la calidad de un producto nunca debe ser comprometida pues la filiáis de calidad no es solo el cumplimiento regulatorio sino exceder el marco de calidad y ahí seguir la voz del cliente es fundamental para desarrollar organizaciones de calidad y no de cumplimiento . Calidad no es negociable y eso debe estar en la cultura y DNA organizacional y de los líderes que la conforman. Calidad no es un atributo es un valor y como tal debe ser puesto como uno de los pilares estratégicos en el plan de negocio.

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2 Use a risk-based approach

Another key step in designing a GMP process is to identify and assess the potential risks that may affect the quality and safety of the product and the process. These risks may include technical, operational, human, environmental, or regulatory factors. You should use a risk-based approach to prioritize and mitigate these risks, and to determine the appropriate level of control and validation for each process step. A risk-based approach can help you optimize your resources, reduce waste, and ensure compliance.

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3 Implement change control and feedback mechanisms

A GMP process is not a static one, and it may need to be changed or updated to respond to changing customer needs or market conditions. However, any change to the product or the process should be carefully controlled and documented, to ensure that it does not introduce new risks or compromise the quality and safety of the product. You should implement a change control system that defines the roles, responsibilities, procedures, and criteria for initiating, reviewing, approving, implementing, and verifying changes. You should also establish feedback mechanisms that allow you to monitor the performance and satisfaction of the product and the process, and to identify opportunities for improvement.

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Jorge W. Rivas Tovar

Technical Operations Director / Plant Director / Plant General Manager
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La gestión de cambios debe ser una norma GMP Debe quedar un récord histórico de los cambios y las razones que sustentan estos cambios Es muy importante que el control de cambio sea holístico e involucre no solo atributos de calidad y especificaciones sino desempe?o , seguridad , eficacia y costo Hoy en día cada vez más sectores documentan cambios con objetivos de reducir impactos ambientales y energéticos como siete de su ciclo de mejora de calidad

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4 Adopt a continuous improvement mindset

Finally, designing a GMP process that adapts to changing customer needs requires a continuous improvement mindset. You should not settle for the status quo, but always look for ways to enhance the quality and efficiency of the product and the process. You should use data, metrics, and best practices to evaluate and benchmark your performance, and to identify gaps and root causes of problems. You should also embrace innovation and creativity, and seek feedback from customers, stakeholders, and peers to generate new ideas and solutions.

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Jorge W. Rivas Tovar

Technical Operations Director / Plant Director / Plant General Manager
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Mejora continua de procesos , gente y tecnología sin pilares clave de la mejora de Calidad La voz del cliente debe ser escuchada y debe ser revisado el sistema integral de calidad bajo el sistema de revisión anual de productos . Todas las áreas operacionales deben participar activamente y comprometerse a tener proyectos de mejora bajo metodologías OPEX. Debe ser un ejercicio de reflexión no solo del área de calidad sino un despliegue de la función de calidad a travez de toda la organización . Los Directivos con una profunda conciencia de calidad debe participar e incentivar la gestión de mejora continua.

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5 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 design a GMP process that adapts to changing customer needs?

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3

4

5

1 Define clear and measurable requirements

2 Use a risk-based approach

3 Implement change control and feedback mechanisms

4 Adopt a continuous improvement mindset

5 Here’s what else to consider

Industrial Design

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How can you design a GMP process that adapts to changing customer needs?

1

2

3

4

5

1 Define clear and measurable requirements

2 Use a risk-based approach

3 Implement change control and feedback mechanisms

4 Adopt a continuous improvement mindset

5 Here’s what else to consider

Industrial Design

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