Quality by Design (QbD) : A new concept for development of quality pharmaceuticals
Abstract
Quality by Design (QbD) has become a new concept for development of quality pharmaceutical products, It is an essential part of the modern approach to pharmaceutical quality, QbD is a best solution to build a quality in all pharmaceutical products but it is also a major challenge to the Pharmaceutical industry whose processes are fixed in time, despite inherent process and material variability, Under this concept of QbD throughout designing and development of a product, it is essential to define desire product performance profile [Target product Profile (TPP), Target Product Quality Profile (TPQP)] and identify critical quality attributed (CQA). On the basis of this we can design the product formulation and process to meet the product attributes. This leads to recognise the impact of raw materials [critical material attributes (CMA)], critical process parameters (CPP) on the CQAs and identification and control sources of variability. QbD is an emerging idea which offers pharmaceutical manufacturer with increased self-regulated flexibility while maintaining tight quality standards and real time release of the drug product, This paper discusses the pharmaceutical QbD and describes how it can be used to develop the pharmaceutical products well within the specified period of time.Keywords:
Quality by Design (QbD), Target Product Profile (TPP), Target Product Quality Profile (TPQP), Critical Quality Attributes (CQA), Critical Material Attributes (CMA), Critical Process Parameter (CPP)References
1. Food and Drug Administration. Final Report on Pharmaceutical cGMPs for the 21st Century - A Risk Based Approach, http://www.fda.gov/ cder/ gmp/gmp 2004/ GMP_ final report 2004.htm
2. Nasr, N., Risk Based CMC Review Paradigm. Advisory Committee for Pharmaceutical Science Meeting 2004, July, 20-21.
3. US Food and Drug Administration. Guidance for Industry. PAT-A Framework for Innovative Pharmaceutical Manufacturing and Quality Assurance. Pharmaceutical cGMPs. Rockville, MD, 2004 Sept., 1-21.
4. Delasko, J.M., Cocchetto, D.M., Burke. L.B., Target Product Profile: Beginning Drug Development with the End in Mind. Update, January/February, Issue 1, 2005, http://www.fdli.org.
5. Food and Drug Administration CDER. Draft Guidance for Industry and Review Staff: Target Product Profile- A Strategic Development Tool (March 2007).
6. Food and Drug Administration Office of Generic Drugs. Model Quality Overall Summary for IR Product, http:// www.fda.gov/ cder/ ogd/ OGD_Model-QoS_IR_Product.pdf (Accessed March 31, 2006)
7. US Food and Drug Administration. Guidance for industry: Q8 Pharmaceutical Development, US Department of Health and Human Service, FDA, Rockville, MD, May 2006.
8. Amidon, G.E., Hageman, X. He, M.J., in: Abraham, D.J, (Eds), Burgers Medicinal Chemistry and Drug Discovery, Vol.2, Wiley-Interscience, New York 2004.
9. US Food and Drug Administration. Guidance for Industry: Q9 Quality Risk Management, US Department of Health and Human Service, FDA, Rockville, MD, June 2006.
10. US Food and Drug Administration, Pharmaceutical cGMPs for the 21st century: A Risk Based Approach, FDA, Rockville, MD, August 2002. http://www.fda. ov/oc/guidance/gmp.html
11. US Food and Drug Administration. Guidance for industry: Q10 Quality Systems Approach to Pharmaceutical cGMP Regulations, FDA, Rockville, MD 2006.
12. Lawrence X, Raw A, Lionberger R, Rajagopalan R, Lee L, Holcombe F, Patel R, Fang F, Sayeed V, Schwartz P, Adams P, and Buehler G. U.S. FDA question-based review for generic drugs: A new pharmaceutical quality assessment system. J. Generic Med 2007; 4:239-248
13. Bhatt D, Rane S. International Journal of Pharmacy and Pharmaceutical Science 2011;Vol 3, Issue 1
14. ICH Harmonized Tripartite Guideline on Pharmaceutical Quality Systems Q10, step 4 version, dated June 4, 2008.
15. Gibson, M., Product Optimization: Pharmaceutical Preformulation and Formulation. Taylor & Francis, New York 2001.
16. Menard, F.A., Presentation to FDA Office of Generic Drugs. September 25, 2006.
17. Rath, T., Strong, D.O., Rath & Strong's Six Sigma Pocket Guide. Lexington, AON Consulting Worldwide, MA 2002
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