Quality- by-design in pharmaceutical development - Computer-Aided Applications in Pharmaceutical Technology - page 14

1.5 Conclusion

Concepts presented in this chapter suggest that there is an ever-growing
need for better understanding of the formulation and process development
by pharmaceutical scientists. Benefi ts of QbD application for both
regulatory agencies and manufacturers have been proven. It is clear the
QbD will become a necessity, therefore all the stakeholders should adapt
to its implementation.

1.6 Notes

1. http://www.fda.gov/downloads/Drugs/DevelopmentApprovalProcess/How
DrugsareDevelopedandApproved/ApprovalApplications/AbbreviatedNew
DrugApplicationANDAGenerics/UCM304305.pdf

http://www.fda.gov/downloads/Drugs/DevelopmentApprovalProcess/How
DrugsareDevelopedandApproved/ApprovalApplications/AbbreviatedNew
DrugApplicationANDAGenerics/UCM286595.pdf

2. http://www.efpia.eu/Content/Default.asp?PageID=559&DocID=2933

1.7 References

Adam, S., Suzzi, D., Radeke, C., and Khinast, J.G. (2011) 'An integrated Quality
by Design (QbD) approach towards design space defi nition of a blending unit
operation by Discrete Element Method (DEM) simulation', Eur. J. Pharm.
Sci. , 42: 106-15.
Am Ende, D.J. (ed.) (2010) Chemical Engineering in the Pharmaceutical Industry .
Hoboken, NJ: John Wiley & Sons, Inc.
Bakeev, K.A. (2010) Process Analytical Technology: Spectroscopic Tools and
Implementation Strategies for the Chemical and Pharmaceutical Industries .
Hoboken, NJ: John Wiley & Sons, Inc.
Charoo, N.A., Shamsher, A.A.A., Zidan, A.S., and Rahman, Z. (2012) 'Quality
by Design approach for formulation development: a case study of dispersible
tablets', Int. J. Pharm. , 423: 167-78.
Cui, Y.' Song, X., Reynolds, M., Chuang, K., and Xie, M. (2011) 'Interdependence
of drug substance physical properties and corresponding quality control
strategy', J. Pharm. Sci. , 101(1): 312-21.
European Medicines Agency (2008) Guidelines on the details of the various
categories of variations to the terms of marketing authorizations for medicinal
products for human use and veterinary medicinal products .
European Medicines Agency/Food and Drug Administration (2011)
EMA-FDA Pilot Program for Parallel Assessment of Quality by Design
Applications .

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