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Detection of N-Nitrosodimethylamine (NDMA) impurities has led to regulatory warnings and product recalls. Pharmaceutical manufacturers must adopt a proactive approach to risk assessment and mitigation in relation to genotoxic contaminants.

Single-Use Systems offer biopharmaceutical manufacturers unique benefits in new and existing applications. Emerson’s measurement instrumentation solutions offer newfound flexibility to scale operations.

This ebooklet walks through the steps required to take a biologic/biopharmaceutical product forward to commercial manufacturing. It distinguishes between a drug and biologic, which is key to understanding the complex requirements for biologics development and manufacture.

This chapter, excerpted from the book Good Distribution Practice, provides background on serialization and how, despite initial investment of time and money, it will allow greater tracking of medicinal product through the drug supply chain and reduce the chance that falsified medicines end up in the hands of the public.

At Rite-Hite, we have many solutions for the pharmaceutical industry along with the knowledge and experience to help you address the issues you face with your clean areas. We keep up-to-date on best practices, new design and technology and the latest trends in the industry.