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Understanding the Role of the ICH, Regulatory Bodies, and Pharmacopeias
Pharmaceutical GMP labs encounter different regulations from local, regional, and international pharmacopeias, as well as supporting organizations and agencies such as the International Council for Harmonization of Technical Requirements for Pharmaceuticals for Human Use (ICH) and the World Health Organization (WHO). However, even with guidance, labs are not always clear which guidelines to follow in certain target markets and which agencies to report to.
Confusion can slow the process of bringing drugs to market, and it can also result in hefty fines. Read this article to learn more about pharmacopoeias and the specific roles of the ICH and WHO.
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