Research Journal of Pharmacy and Technology

SCOPUS
  • Year: 2017
  • Volume: 10
  • Issue: 9

Quality by Design approaches to Analytical Method Development

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

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

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.