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

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...

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Bibliographic Details
Published inJournal 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
LanguageEnglish
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)
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Summary: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 supply chain and control strategy, and how changes to such outcomes are managed over the lifecycle. A series of articles will address “flexibility” and look to provide recommendations for the further development of the ICH Q11 vision. The focus of this work will address flexibility associated with the “Enhanced Approaches to the Development of the Control Strategy and Its Implementation in the Manufacturing Process Description.”
ISSN:1872-5120
1939-8042
DOI:10.1007/s12247-018-9340-2