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Research Journal of Pharmacy and Technology
Year : 2017, Volume : 10, Issue : 9
First page : ( 3188) Last page : ( 3194)
Print ISSN : 0974-3618. Online ISSN : 0974-360X.
Article DOI : 10.5958/0974-360X.2017.00567.4

Quality by Design approaches to Analytical Method Development

Das Vedantika1,*, Bhairav Bhushan1, Saudagar R. B.2

1Department of Quality Assurance, R.G. Sapkal College of Pharmacy, Anjaneri, Nashik

2Department of Pharmaceutical Chemistry, R.G. Sapkal College of Pharmacy, Anjaneri, Nashik

*Corresponding Author E-mail: vedantika19@gmail.com

Online published on 16 May, 2018.

Abstract

The concept of QbD to the analytical method development is as known AQbD (Analytical Quality by design). It is an informal in the pharmaceutical industry to perform analytical quality by design (AQbD) in method development activity as a part of risk management, pharmaceutical development, and pharmaceutical quality system. Testing of final product is not enough, but prominence is on ‘Total Quality Management’ through inprocess testing and analysis is required today. The International Conference for Harmonization (ICH) has announced regulatory guidelines for pharmaceutical development.

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