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Journal of Chemistry - Volume 2015 2015, Article ID 435129, 8 pages -

Review Article

Hetero Drugs Ltd. R&D, Plot No. B. 80 & 81, APIE, Balanagar, Hyderabad, Andhra Pradesh, India

Department of Chemistry, Sri Krishnadevaraya University, Anantapur, Andhra Pradesh, India

Department of Chemistry, JNT University, Hyderabad, Andhra Pradesh, India

Received 24 October 2014; Revised 18 December 2014; Accepted 1 January 2015

Academic Editor: Romdhane Karoui

Copyright © 2015 N. V. V. S. S. Raman et al. This is an open access article distributed under the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited.


Pharmaceutical industry has been emerging rapidly for the last decade by focusing on product Quality, Safety, and Efficacy. Pharmaceutical firms increased the number of product development by using scientific tools such as QbD Quality by Design and PAT Process Analytical Technology. ICH guidelines Q8 to Q11 have discussed QbD implementation in API synthetic process and formulation development. ICH Q11 guidelines clearly discussed QbD approach for API synthesis with examples. Generic companies are implementing QbD approach in formulation development and even it is mandatory for USFDA perspective. As of now there is no specific requirements for AQbD Analytical Quality by Design and PAT in analytical development from all regulatory agencies. In this review, authors have discussed the implementation of QbD and AQbD simultaneously for API synthetic process and analytical methods development. AQbD key tools are identification of ATP Analytical Target Profile, CQA Critical Quality Attributes with risk assessment, Method Optimization and Development with DoE, MODR method operable design region, Control Strategy, AQbD Method Validation, and Continuous Method Monitoring CMM. Simultaneous implementation of QbD activities in synthetic and analytical development will provide the highest quality product by minimizing the risks and even it is very good input for PAT approach.

Autor: N. V. V. S. S. Raman, Useni Reddy Mallu, and Hanimi Reddy Bapatu



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