Quality by Design in Action 1: Controlling Critical Quality Attributes of an Active Pharmaceutical Ingredient

The importance of Quality by Design (QbD) is being realized gradually, as it is gaining popularity among the generic companies. However, the major hurdle faced by these industries is the lack of common guidelines or format for performing a risk-based assessment of the manufacturing process. This article tries to highlight a possible sequential pathway for performing QbD with the help of a case study. The main focus of this article is on the usage of failure mode and effect analysis (FMEA) as a tool for risk assessment, which helps in the identification of critical process parameters (CPPs) and critical material attributes (CMAs) and later on becomes the unbiased input for the design of experiments (DoE). In this case study, the DoE was helpful in establishing a risk-based relationship between critical quality attributes (CQAs) and CMAs/CPPs. Finally, a control strategy was established for all of the CPPs and CMAs, which in turn gave rise to a robust process during commercialization. It is noteworthy that FMEA was used twice during the QbD: initially to identify the CPPs and CMAs and subsequently after DoE completion to ascertain whether the risk due to CPPs and CMAs had decreased……….http://pubs.acs.org/doi/abs/10.1021/op500295a

Quality by Design in Action 1: Controlling Critical Quality Attributes ofan Active Pharmaceutical Ingredient

Abdul Qayum Mohammed ^†‡, Phani Kiran Sunkari^†, P. Srinivas ^*‡, and Amrendra Kumar Roy ^*†

^† CTO-III, Dr. Reddy’s Laboratories Ltd, Plot 116, 126C and Survey number 157, S.V. Co-operative Industrial Estate, IDA Bollaram, Jinnaram Mandal, Medak District, Telangana 502325, India

^‡ Department of Chemistry, Osmania University, Hyderabad, Telangana 500007, India

Org. Process Res. Dev., Article ASAP

DOI: 10.1021/op500295a

Publication Date (Web): January 21, 2015

Copyright © 2015 American Chemical Society

*Telephone: +919701346355. Fax: + 91 08458 279619. E-mail: amrendrakr@drreddys.com (A.K.R.)., *E-mail:sripabba85@yahoo.co.in (P.S.).

http://pubs.acs.org/doi/abs/10.1021/op500295a

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