Nueva etapa para QbD Pharmaceutical Services

Evento 23 SeptiembreIniciamos una nueva etapa mediante una alianza con la empresa belga “Quality by Design” que se acaba de concretar mediante la constitución de una empresa española, filial de la anterior y participada por nosotros llamada QbD PharmaProjects Spain S.L (QbD PPS).

La oferta de servicios de QbD PPS en España aúna la experiencia combinada de los originadores en consultoría farmacéutica, de más de 15 años, con un equipo de consultores de casi 100 personas.

Los servicios abarcan todo el ciclo de vida de APIs y medicamentos:

•         Desarrollo: Quality by Design y Transferencias de Tecnología.

•         Manufacturing: Compliance / Quality Assurance, Cualificaciones / Validaciones (equipos, instalaciones, procesos y CSV)

QbD PPS introduce en España un servicio de staffing novedoso llamado “Academy Model” que facilita la identificación y retención de talento de jóvenes profesionales para las empresas farmacéuticas.

El pasado 23 de septiembre, recibimos a nuestros socios europeos para presentar conjuntamente los servicios de QbD PharmaProjects Spain a un nutrido grupo de profesionales de la industria farmacéutica.

Los asistentes fueron guiados a través de las diversas etapas del ciclo de vida del medicamento – desde el diseño hasta la validación y continuando con la mejora continua.

El seminario comenzó con una charla sobre SmartQbD, presentado por la Sra. Alicia Tébar. Este método se ha desarrollado en base a la experiencia acumulada a lo largo de 10 años de implantación en el uso de las herramientas de risk analysis y DoE en departamentos de desarrollo con diferentes targets y tipos de productos.

A continuación el Sr. Martijn Reniers presentó la metodología de Transferencia de Tecnología que QbD está aplicando en diversos proyectos para aumentar la eficiencia y disminuir los riesgos de calidad.

Después de estas dos presentaciones, tuvimos una pausa para el café y los asistentes pudieron disfrutar del mismo con una taza personalizada con su nombre.

Volvimos a las presentaciones con el Sr. Bart Van Acker (CEO de QbD Bélgica) y las aplicaciones de la Gestión de riesgos en validación. A continuación, el Sr. Albert Verschoor dio una inspiradora charla sobre Sistemas de Gestión de Calidad. Por último, Alicia y Bart se unieron para presentar el Academy Model, a lo que siguieron algunas preguntas por parte de los asistentes.

Tras el seminario, se sirvió un almuerzo en el que los foráneos pudieron apreciar la cocina catalana. Recibimos comentarios muy positivos de la audiencia sobre los servicios presentados durante el almuerzo al aire libre.

Agradecemos su presencia a los asistentes y la posibilidad de obtener un feedback que nos será muy útil en nuestra intención de proporcionar  un servicio excelente a las empresas farmacéuticas españolas.

 

 

QbD Spain and QbD Benelux join forces.

QbDs join forces

We are proud to announce the signature of a partnership with the Belgian Quality by Design, the expert in quality management for Benelux enterprises in the pharmaceutical, biotechnical and cosmetics industries.

From now on, we offer new services for the spanish market, including training, coaching and a technology transfer framework developed by the Belgian company, who in turn offers to their customers the implementation of SMART QbD– the quality by design method that we have developed after 10 years of practical implementation .

With this cooperation both companies expand their services within Europe and combine their expertise. This combined expertise turns QbD as a key option for the pharma sector, to provide support and advice along the entire life cycle of the product, from development to distribution, providing them with specific knowledge, skills and tools.

Bart van Acker, founder and managing director Quality by Design: “The cooperation with QbD Pharmaceutical Services is a great step for QbD. Since 2011 we support Benelux companies and their quality management processes, and with this new partnership we expand our services to the rest of Europe. Thanks to the addition of the SMART QbD methodology to our portfolio, we are the only player in the market to offer all services under one roof – from validation and quality management to technology transfers and quality by design processes. Besides, thanks to our contacts in Spain we gain access to the fast growing South American market.”

Alicia Tébar, CEO QbD Pharmaceutical Services: “We are very pleased with this partnership. QbD only employs qualified, motivated people with a passion for helping companies to accelerate and improve their go-to-market process. With this cooperation we do not only expand our services portfolio, but also increase our knowledge and expertise. It’s a great step towards our European growth. We are looking forward to a successful cooperation and to helping clients comply with the variable rules and processes.”

 

Latests trends in Quality by Design: SMART QbD

SMART QbDThe last number of Farmaespaña Industrial publishes our article:

“Ultimas tendencias en la aplicación de Quality by Design: SMART QbD”.

SMART QbD FE Feb 2016

This article describes the methodology SMART QbD which is the result of our 10 years’ experience in QbD practical implementation in more than 20 companies, including drug products and active substances manufacturers.

This article describes the modular methodology that we have developed, based on lessons learned in real projects QbD implementation, and that we have called SMART QbD.

During development, this is about applying the tools efficiently, adapting to the available resources and taking into account the restrictions imposed by the business objectives and “time to market”. Once the product is launched, and during its commercial life,  the maintenance of the risk management system is of capital importance.

QbD is the standard in pharmaceutical development, especially for companies whose goal is to sell products in the American market. Even if development was made a few years ago and are currently approved in other countries, it would be convenient to complement it with the QbD approach to fill knowledge gaps and to issue documentation packages that meets FDA  evaluators criteria.

For example in this article Backlog unapproved ANDAS the increase in ANDAs time assessment is discussed. Main reason due to the increase in the number of generic products presented and that some of the “pre-selection” criteria is the fulfillment of the quality standards in the information presented:

“A good example is ‘quality by design,’” he said, referring to the agency’s new criteria for good manufacturing processes. “They’d say, ‘Your application isn’t very good because you didn’t have the quality by design concept.”

In conclusion, to avoid delays and questions is it highly advisable to present the information following the scheme of “Question Based Review” which in turn means having introduced the QbD methodology.

For more information please contact us.

 

 

 

 

SMART QbD in Pharmaprocess

20151028_133417Pharmaprocess, the Innovation Forum in pharmaceutical processes, has closed the 2015 edition in Barcelona with a great success.

We had the pleasure to participate in the Regulatory & Development track in the session “QbD at minimum or full application”

Ms. Beatriz Artalejo, president of AEFI (spanish industry pharmacists association) presented the speakers and facilitated Q&A final part.

Our speech “How to apply QbD in a SMART way” was adressed to explain SMART QbD ™ methodology that we use to support our customers QbD projects.

To some extent, the idea that still persists is that implementing QbD is complex and / or expensive despite the obvious advantages.

SMART QbD™  is a methodology that adapts to the timing and project constraints but providing appropriate tools to optimize the acquisition of the key knowledge about the product/process with the available resources.

The key feature is efficiency in applying QbD tools: risk analysis, design of experiments and project management. Finding the way to re-use the knowledge we get and not inventing the wheel every time is the key.

We shared with assistants some real examples on how to use non-formal DoE previous trials and other previous knowledge to avoid starting from scrach with surprisingly good results.

Risk analysis is another time consuming process that can be adressed to save the time devoted to endless meetings.

Mr. Frédéric Vaurès Technical Manager – Colorcon Iberica explained the new services that excipient supliers offer to ease the QbD efforts of their customers. Critical attributs of functional ingredients can be crucial for manufacturability or even for the product quality.

The session ended with Q&A. Thanks Pharmaprocess!!