An Overview - International Conference on Harmonisation and ICH (Q1) Stability Testing Guideline for Pharmaceutical Development

Mr. Anil Keshav Pawar
2019 International Journal for Research in Applied Science and Engineering Technology  
The international conference on harmonisations is the invention of three regulatory agency USA, JAPAN, EUROPE. The ICH bringing together with regulatory affair for registration of product and scientific, technical aspect. The mission of the ICH is to improve worldwide harmonization with safety and efficacy also registration and development of high quality with good manner. The ICH in quality area which provide guidance to conduct stability study, impurity detection, pharmaceutical manufacturing
more » ... and development, regulatory aspect, good manufacturing practices, quality risk management. The ICH quality guideline control and improve pharmaceuticals drug development with better harmonization.
doi:10.22214/ijraset.2019.12163 fatcat:lpxrrl7r3vdalkaz3c27pgqtsi