Critical Quality Attributes and Specifications

Are you starting to scale up your product manufacturing process?

Are you implementing your QbD/PAT project?

We help you to develop analytical methods on the QbD principles = Analytical Quality by Design (AQbD).

We help you to plan your Design Space aiming to identify the Critical Material Attributes (CMA) and set the specification limits for the CMA.

Do you know that the solid-state properties such as the particle size distribution, specific surface area or polymorphic form very often are the CMA?

We can help you with setting specifications using the ICH guidelines.

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Literature:

Ramalingam P, Jahnavi B. QbD considerations for analytical development. In Pharmaceutical Quality by Design 2019 Jan 1 (pp. 77-108). Academic Press.


ICH topic Q6a specifications: Test procedures and acceptance criteria for new drug substances and new drug products. 

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