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Top 5 trends in non-compliance in Pharma Manufacturing

Vivek Gera

Pharmaceutical companies operate in one of the most dynamic environments. Changes in regulations by leading bodies such as US Food and Drug Administration (USFDA) and the European Medicines Agency (EMA) have increased the significance of regulatory compliance management for drug manufacturers. We analysed a total of 155 warning letters issued by FDA’s Office of Manufacturing Quality (OMQ) from 2015–2018. The infographic below illustrates the findings.


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