Lucideon Publishes White Paper on Quality by Design for the Pharmaceutical Industry

Lucideon has published a new white paper, ‘Why Quality by Design?’ for the Pharmaceutical industry.

Written by Nigel Rich, Pharmaceutical Chemistry Manager at Lucideon, the paper discusses the Quality by Design (QbD) approach to method development.  Nigel explores the pros and cons of adopting QbD methodology, providing a detailed insight into the many advantages that can be easily overlooked regarding the adoption of the method.

Lucideon offers expert method development, QC and QA, testing and analysis and cleanliness validation through its state-of-the-art pharmaceutical laboratories.  Lucideon’s experience and expertise provide informed and efficient method development which often involves the QbD approach.  QbD allows for greater understanding of the process including in built quality control and greater flexibility of variable parameters and process changes.

Nigel Rich said: “Although the QbD approach to method development is more involved, requiring more research and time to develop, it does save a lot of time further down the line.

“Regulatory bodies take a favourable view to products developed with the QbD approach as it is good practice, showing a greater level of understanding of the process and the defining parameters of the variables.  This produces a more efficient, flexible and safer process.”

Lucideon’s method development service provides complete method development for pharmaceutical, medical device and consumer healthcare products.  All development is performed to ICH guidelines and is supported by the wide range of complementary analytical and testing services Lucideon offers.

To find out more about Lucideon’s method development services visit www.lucideon.com/method-development.

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Resources

  • White paper

    Quality by Design for the Pharmaceutical Industry

    pdf 835 KB

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