Part 3: Enhanced Approaches to the Development of the Control Strategy and its Implementation in the Manufacturing Process Description

• Published in: Journal of pharmaceutical innovation Vol. 14; no. 1; pp. 1 - 14
• Main Authors: Popkin, Matt E., Omer, Batool Ahmed, Seibert, Kevin D., Luciani, Carla V., Srivastava, Sushil, Hobson, Lindsay, Lepore, John V.
• Format: Journal Article
• Language: English
• Published: New York Springer US 15.03.2019
• Subjects: Biochemical Engineering; Biomedical and Life Sciences; Biomedicine; Biotechnology; Industrial and Production Engineering; Pharmacology/Toxicology; Review Article; Design space; Manufacturing process description S2.2; CMC; Design of experiment (DoE); Process; Models; Kinetics; Control strategy; Methods; ICH; Quality by design (QbD)

A series of case histories from IQ consortium member companies will be presented to exemplify how the application of the ICH Q11 vision for enhanced Quality by Design (QbD) development of the active pharmaceutical ingredient (API) can lead to differentiated outcomes for elements such as the API supp...