A Process Analytical Technology (PAT) approach to control a new API manufacturing process: Development, validation and implementation-Reference-Cited by-同舟云学术

A Process Analytical Technology (PAT) approach to control a new API manufacturing process: Development, validation and implementation

Published:2014-03 Issue: Volume:120 Page:114-125
ISSN:0039-9140
Container-title:Talanta
language:en
Short-container-title:Talanta

Author:

Schaefer Cédric,Clicq David,Lecomte Clémence,Merschaert Alain,Norrant Edith,Fotiadu Frédéric

Funder

Ministère de l'Education Nationale, de l'Enseignement Superieur et de la Recherche

UCB Pharma

Association Nationale de la Recherche et de la Technologie

Publisher

Elsevier BV

Subject

Analytical Chemistry

Reference51 articles.

1. United States Food and Drug Administration (FDA), Guidance for industry PAT – A Framework for Innovative Pharmaceutical Manufacturing and Quality Assurance, 2004.

2. International Conference on Harmonization (ICH), Pharmaceutical Development, Q8(R2), 2009.

3. International Conference on Harmonization (ICH), Quality Risk Management, Q9, 2005.

4. International Conference on Harmonization (ICH), Pharmaceutical Quality System, Q10, 2008.

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