Part 3: Enhanced Approaches to the Development of the Control Strategy and its Implementation in the Manufacturing Process Description
| Autor: | Carla V. Luciani, Lindsay A. Hobson, Batool Ahmed Omer, Kevin D. Seibert, Sushil K. Srivastava, Matt E. Popkin, John Lepore |
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| Rok vydání: | 2018 |
| Předmět: |
Flexibility (engineering)
Process management Manufacturing process Computer science Supply chain Control (management) Pharmacology toxicology Pharmaceutical Science 02 engineering and technology 021001 nanoscience & nanotechnology 030226 pharmacology & pharmacy Quality by Design 03 medical and health sciences 0302 clinical medicine Development (topology) Work (electrical) Drug Discovery 0210 nano-technology |
| Zdroj: | Journal of Pharmaceutical Innovation. 14:1-14 |
| ISSN: | 1939-8042 1872-5120 |
| Popis: | 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.” |
| Databáze: | OpenAIRE |
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