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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. Top | |
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