Application of the QbD principles in the development of the casopitant mesylate manufacturing process. Process research studies for the definition of the control strategy of some drug substance-CQAs for stages 2a, 2b, and 2c

Organic Process Research and Development

Volumn 14, Issue 4, 2010, Pages 805-814

  Cimarosti, Zadeo ^a   Bravo, Fernando ^a   Castoldi, Damiano ^a   Tinazzi, Francesco ^a   Provera, Stefano ^a   Perboni, Alcide ^a   Papini, Damiano ^a   Westerduin, Pieter ^a  

^a GSK   (Italy)

Author keywords

[No Author keywords available]

Indexed keywords

CONTROL STRATEGIES; DRUG DISCOVERY; DRUG SUBSTANCES; GLAXO SMITHKLINE; INFLAMMATORY BOWEL DISEASE; MANUFACTURING PROCESS; POTENTIAL ACTIVITIES; PROCESS DEVELOPMENT; PROCESS UNDERSTANDING; QUALITY BY DESIGNS; QUALITY PROCESS; RESEARCH STUDIES; THERAPEUTIC TARGETS;

DESIGN OF EXPERIMENTS; INDUSTRIAL ENGINEERING; PRODUCTION ENGINEERING; QUALITY ASSURANCE; RISK ANALYSIS; RISK ASSESSMENT;

QUALITY CONTROL;

EID: 77955409770     PISSN: 10836160     EISSN: 1520586X     Source Type: Journal    
DOI: 10.1021/op1000622     Document Type: Article

References (6)

1. ICH Q8 Pharmaceutical Development
2. ICH Q9 Quality Risk Management
3. ICHQ 10 Pharmaceutical Quality System.
4. See for example: Pharmaceutical cGMPs for the 21st century-A risk based approach, Final Report; U.S. Department of Health and Human Services, Food and Drug Administration, Center for Drug Evaluation and Research (CDER): Silver Spring, MD, U.S.A., 2004.
5. Cimarosti, Z.; Bravo, F.; Stonestreet, P.; Tinazzi, F.; Vecchi, O.; Camurri, G. Org. Process Res. Dev. ASAP-DOI: 10.1021/op900242x.
6. Guercio, G.; Bacchi, S.; Perboni, A.; Leroi, C.; Bientinesi, I.; Hourdin, M.; Goodyear, M.; Curti, S.; Provera, S.; Cimarosti, Z. Org. Process Res. Dev. 2009, 13, 1100-1110