Application of quality by design principles to support development of a control strategy for the control of genotoxic impurities in the manufacturing process of a drug substance

Organic Process Research and Development

Volumn 14, Issue 4, 2010, Pages 993-998

  Cimarosti, Zadeo ^a   Bravo, Fernando ^a   Stonestreet, Paul ^b   Tinazzi, Francesco ^a   Vecchi, Orsola ^a   Camurri, Giulio ^a  

^a GSK   (Italy)

^b GLAXOSMITHKLINE   (United Kingdom)

Author keywords

[No Author keywords available]

Indexed keywords

CENTRAL NERVOUS SYSTEMS; CONTROL STRATEGIES; CRITICAL QUALITY; DRUG SUBSTANCES; ETHYL METHANESULFONATE; GENOTOXIC IMPURITIES; GLAXO SMITHKLINE; IN-PROCESS CONTROL; MANUFACTURING PROCESS; METHANESULFONATES; PROCESS DEVELOPMENT; PROCESS UNDERSTANDING; QUALITY ATTRIBUTES; QUALITY BY DESIGNS; QUALITY PROCESS; STARTING MATERIALS;

INDUSTRIAL ENGINEERING; PRODUCTION ENGINEERING; QUALITY ASSURANCE; RISK ANALYSIS; RISK ASSESSMENT;

PROCESS CONTROL;

EID: 77955350069     PISSN: 10836160     EISSN: 1520586X     Source Type: Journal    
DOI: 10.1021/op900242x     Document Type: Article

References (4)

1. ICHQ8 Pharmaceutical Development, ICHQ9 Quality Risk Management, ICHQ10 Pharmaceutical Quality System.
2. Questions and answers to the follow-up to the contamination of Viracept (nelfinavir) with ethyl mesylate. EMEA/CHMP/375807/2008. London: European Medicines Agency, 2008. http://www.emea.europa.eu/human-docs/PDFs/EPAR/Viracept/ Q&A-Viracept-37580708en.pdf (accessed 10 October 2009).
3. Teasdale, A.; Eyley, S. C.; Delaney, E.; Jacq, K.; Taylor-Worth, K.; Lipczynski, A.; Reif, V.; Elder, D. P.; Facchine, K. L.; Golec, S.; Schulte Oestrich, R.; Sandra, P.; David, F. Org. Process Res. Dev. 2009, 13, 429-433
4. Amount of intermediate coming from 1 wt of the isolated intermediate 3.