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APV Expert WorkshopQuality by Design based formulation strategies
in continuous processing5./6. June 2019
Leicester, EnglandCourse no. 6771Pharmaceutical Manufacturing In cooperation withArbeitsgemeinschaft
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Here is how to fill out quality by design based:
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Define the purpose and scope of the project.
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Identify critical quality attributes (CQAs) that are important for the product.
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Design experiments to study the relationship between CPPs and CQAs.
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Collect and analyze the data from the experiments.
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Use statistical methods to establish the design space and define the control strategy.
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What is quality by design based?
Quality by design is based on the principle of designing quality into a product or process from the beginning.
Who is required to file quality by design based?
All manufacturers and developers of products or processes are required to file quality by design based.
How to fill out quality by design based?
To fill out quality by design based, one must follow the guidelines and requirements set forth by the regulatory bodies.
What is the purpose of quality by design based?
The purpose of quality by design based is to ensure that products or processes meet quality standards consistently.
What information must be reported on quality by design based?
Information such as design specifications, risk assessments, testing protocols, and validation data must be reported on quality by design based.
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