Recent trends and harmonization of quality risk management

  • Manoj Charde Government College of Pharmacy, Kathora Naka, Amravati-444604, Maharashtra
  • P. Ingole Government College of Pharmacy, Kathora Naka, Amravati-444604, Maharashtra
  • A. S. Welankiwar Government College of Pharmacy, Kathora Naka, Amravati-444604, Maharashtra
  • J. Kumar Government College of Pharmacy, Kathora Naka, Amravati-444604, Maharashtra
  • R. D. Chakole Government College of Pharmacy, Kathora Naka, Amravati-444604, Maharashtra
Keywords: Pharmaceutical quality system, quality risk management, critical parameter, GMP, WHO

Abstract

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.

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Published
2013-10-03
Section
Review Article