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DR ANTHONY MELVIN CRASTO, WORLDDRUGTRACKER

QbD: Controlling CQA of an API

 QbD  Comments Off on QbD: Controlling CQA of an API
Sep 132016
 

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 theQbD: initially to identify the CPPs and CMAs and subsequently after DoE completion to ascertain whether the risk due to CPPs and CMAs had decreased.

 

 

 

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

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

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

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., 2015, 19 (11), pp 1634–1644
*Telephone: +919701346355. Fax: + 91 08458 279619. E-mail: amrendrakr@drreddys.com (A.K.R.)., *E-mail:sripabba85@yahoo.co.in (P.S.).

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////// QbD, DoE, FMEA, ANOVA, Design space.
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