Abstract
Background: The dynamic pharmaceutical industry is driven by regulatory authorities viz. Central Drug Standard Control Organization (CDSCO) for India, European Agency for the Evaluation of Medicinal Products (EMEA) for Europe, Therapeutic Products Directorate (TPD) for Canada, Medicines and Healthcare Products Regulatory Agency (MHRA) for UK, Therapeutic Goods Administration (TGA) for Australia, Medicines Control Council (MCC); however the most prominent among the regulatory agency is US Food and Drug Administration (FDA). Keywords: Regulatory audit, regulatory authorities, warning letters, compliance, 483s.
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