Worldwide Good Manufacturing Practices

Abstract

The European Union (EU) is an economic and political partnership between 28 European countries that together cover much of the continent of Europe. European law works by Directives being issued from the EU. These Directives must then be incorporated into national law by each Member State of the EU. It is a legal requirement that sites in Europe making human or animal medicinal products work to the relevant Directive. In order to get the right to make medicines, the site must have a Manufacturing Authorization— a licence to make medicines that is granted by the national Regulatory Authority. In Japan, Good Manufacturing Practices (GMP) is regulated and inspected by the Ministry of Health, Labor, and Welfare. The Pharmaceutical Affairs Law in Japan sets the legal framework for GMP. The World Health Organization (WHO) also produces a Guide to GMP. The WHO does employ GMP inspectors, many of whom used to work for national Regulatory Authorities.