Acino And Mitsubishi Tanabe Pharma Contravene Manufacturing Rules

It is BMI's view that adhering to quality manufacturing standards is one of the few fundamental responsibilities of a pharmaceutical company. Synthesis of active pharmaceutical ingredients (APIs) is a complex task that must be undertaken in sterile conditions. Furthermore, waste products have to be disposed of safely and it is essential that process documentation is in order for scrutiny by regulatory agencies. Failure to maintain pharmaceutical production quality can result in serious consequences, as demonstrated by two recent developments.

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