Deepika Purohit, Manisha Saini, Parijat Pandey, Swagat Tripathy and Harish Dureja* Pages 99 - 111 ( 13 )
Background: In pharmaceutical terms, quality means a product free from any contamination and delivers the therapeutic benefit specified in the label at a reproducible rate which can be assessed by carrying out in vivo or in vitro tests for evaluation of performance. Quality by Design (QbD) is a necessary tool in pharmaceutical environment for having product/process/method impregnated with quality. QbD is a move toward drug development that ensures the preplanned product specifications by providing guidance for architecting the manufacturing processes and formulation.
Methodology: It has provided the solution to support both the regulatory bodies and industry to shift towards added proactive and scientific approach. QbD is the greatest solution to construct quality in all pharmaceutical products, while at the same time, making it a part of the system is also a key challenge for the industry. By using QbD concept, regulators as well as industries are making a move in geometric progress in bringing quality products. Regulatory bodies across the world are showing significant attention to QbD.
Conclusion: Therefore, an attempt has been made to highlight quality by designing generic drugs and its implications to pharmaceutical industry including clinical trials, pharmaceutical validation processes and in biologics and also to provide a brief description on the status of QbD in India and as well as in Asia.
Quality by design, critical material attribute, critical process parameter, quality profile, target product, target product profile.
Department of Pharmaceutical Sciences, Indira Gandhi University, Meerpur, Rewari 123401, BresMed Health Solutions 906-912, JMD Megapolis, Gurugram, Haryana 122018, Shri Baba Mastnath Institute of Pharmaceutical Sciences and Research, Baba Mastnath University, Rohtak 124001, Aurobindo Pharma Limited, R&D Center 1, Hyderabad, Bachupally, Telangana 500090, Department of Pharmaceutical Sciences, Maharshi Dayanand University, Rohtak 124001