Analytical Quality by Design Concise Review on Approach to Enhanced Analytical Method Development

Bhosale Abhilash, Darekar Shubhangi, Dr. V. U Barge, Dr. Ashok Bhosale
2020 Zenodo  
In the last few decades, the pharmaceutical industry has been rapidly progressing by focussing on various aspects of formulation and analytical development such as product Quality, Safety, and Efficacy. It is reflected through the increase in number of product development by the increased use of scientific tools such as QbD Quality by Design and PAT Process Analytical Technology . ICH guidelines Q8 to Q11 have specified QbD implementation in API synthetic process and also in formulation as well
more » ... formulation as well as analytical development. QbD has earned considerable reputation by formulation developers. It has enhanced the inculcation of scientific outlook and assessment of risks at an early stage. In this review, we have focussed on the implementation AQbD 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, and, MODR method operable design region . AQbD intends to provide product with highest quality through the minimisation of risks and also by providing good input for PAT approach. Thus, AQbD can act as an effective method towards innovative approach of Analytical Method Development along with meeting the necessary desired specifications. Bhosale Abhilash | Darekar Shubhangi | Dr. V. U Barge | Dr. Ashok Bhosale "Analytical Quality by Design: Concise Review on Approach to Enhanced Analytical Method Development" Published in International Journal of Trend in Scientific Research and Development (ijtsrd), ISSN: 2456-6470, Volume-4 | Issue-3 , April 2020, URL: Paper Url :
doi:10.5281/zenodo.3892381 fatcat:7zheo4fovndqvpuubltnhewvi4