Quality by Design: Concept for the Proof-of-Principle Testing Regarding Automated Microdosing

Rubrik: Originale

(Treffer aus pharmind, Nr. 01, Seite 145 (2012))

Sternberger-Rützel E | Runft W | Beck M | Weber E | Kleiner M | Gumpinger B | Müller I

Quality by Design: Concept for the Proof-of-Principle Testing Regarding Automated Microdosing / Sternberger-Rützel et al. • Quality by Design · Sternberger-Rützel E, Runft W, Beck M, Weber E, Kleiner M, Gumpinger B, Müller I · ¹ Robert Bosch GmbH, Business Unit Packaging Technology, Waiblingen, Germany und ² University of Applied Sciences of Albstadt-Sigmaringen, Faculty of Life Sciences,
Pharmaceutical Engineering, Sigmaringen, Germany und
Adjustable and fixed vacuum dosing wheel Automated microdosing Filling weight statistics Particle size distribution Powder rheology Quality by design (QbD) is a well-known tool used by the pharmaceutical industry for formulation or process optimization as a scientific and risk-based approach that is required by the regulatory authorities. The U.S. Food and Drug Administration (FDA) as well as the European authorities put an emphasis on QbD strategies during the development and manufacturing of medicinal products. In the FDA's “Guidance for Industry: Quality Systems Approach to Pharmaceutical cGMP Regulations” it is explained that “Quality by Design means designing and developing a product ...