Very recently, Food and Drug Administration (FDA) has approved a few new drug
applications (NDA) with regulatory flexibility for quality by design (QbD) based analytical …

In this era of competition quality has been given prime magnitude; failure to meet such
quality allied goals produces massive shift of company in share of market. In this context …

Summary International Conference on Harmonisation (ICH) Q2 (R1) provides a formal
overview of the criteria required to fully validate an analytical procedure. It highlights that the …

ABSTRACT Quality-by-design (QbD) is a systematic approach to drug development, which
begins with predefined objectives, and uses science and risk management approaches to …

Since the adoption of the ICH Q8 document concerning the development of pharmaceutical
processes following a Quality by Design (QbD) approach, there have been many …

Pharmaceutical regulatory bodies increasingly require the implementation of systematic
approaches in pharmaceutical product development. Quality control methods play a key role …

Analytical methods are utilized throughout the biopharmaceutical and vaccines industries to
conduct research and development, and to help control manufacturing inputs and outputs …

This study tests the impact of drone transportation on the quality of a medicine. Modelling the
critical process parameters of drone flight, the effects of temperature and vibration on insulin …

Abstract Background Quality by design (QbD) refers to the achievement of certain
predictable quality with desired and predetermined specifications. A quality-by-design …

The pharmaceutical industry is highly regulated by quality policies. The concept of risk
management is strongly integrated into the quality assurance system to ensure …