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Quality assurance in medicines

Learning objective

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The objective and function of the pharmaceutical industry is to produce (and discover, for some industries) and market safe, high-quality, and efficacious medicines. Many organizations have formulated guidelines for producing quality medicines, including the US Food and Drug Administration (FDA), the Medicines and Healthcare Products Regulatory Agency (MHRA), the European Medicine Evaluation Agency (EMEA), the International Conference on Harmonization of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH), the World Health Organization (WHO), the Pharmaceutical Inspection ...

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