CONCLUSION
This article aims to illustrate the need to achieve operational excellence with respect to data- and knowledge-management
systems to successfully implement QbD for manufacturing of biotherapeutics. As discussed, there is a great need among the
biomanuacturing industry to apply risk-assessment and management principles to achieve this objective. When done correctly,
this approach is more economical and effective than traditional approaches otherwise used in industry.
Anshuman Bansal, PhD, and Jaspinder Hans are cofounders of Simplyfeye Softwares in Delhi, India. Anurag Rathore, PhD, is a partner at Simplyfeye and a faculty member at the Indian Institute of Delhi, India, +91-9650770650, asrathore@biotechcmz.com
. Rathore is also a member of BioPharm International's editorial advisory board.
REFERENCES
1. "Operational excellence" as defined by Industry Week,
http://www.industryweek.com/articles/operational_excellence_defined_14011.aspx
2. ICH, Q8(R1): Pharmaceutical Development, November, 2008.
3. A.S. Rathore and H. Winkle, Nature Biotechnology, 27 (1) 26–34 (2009).
4. A.S. Rathore, Trends in Biotechnol.
27 (9) 546–553 (2009).
5. R. Johnson et al., BioPharm. Intl., 20 (10) 130–144 (2007).
6. P. Konold, R. Woolfenden II, Cenk Undey, and A. S. Rathore, BioPharm. Intl.
22 (5) 26–39 (2009).
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