Recent trends and harmonization of quality risk management

Manoj Charde, P. Ingole, A. S. Welankiwar, J. Kumar, R. D. Chakole


The World Health Organization (WHO) of the United Nations finalized the Annex 2 of the new technical Report 981 that is called as WHO guideline on the implementation of a Quality Management System, in July 2013. WHO requirements with the harmonized guidelines concern with harmonized European, US and Asian regulations. This article includes the role of Quality Risk Management in pharmaceutical quality system.


Pharmaceutical quality system, quality risk management, critical parameter, GMP, WHO



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