Be confident in your analytical R&D and process development
Pressure to get your product to market – on time and on budget – is high. It can be tempting to “not sweat the small stuff.” But when it comes to impurities, those little peaks on your chromatogram can grow into big problems down the road. Building quality into the earlier stages of the product development and manufacturing lifecycle can save time and resources in the long run.
Impurities in pharmaceutical R&D and manufacturing are a fact of life. New manufacturing processes, more complex drug formulations and increasingly complicated global supply chains for materials and ingredients are making it more difficult for companies to assess and control for impurities. In addition, a spate of recalls due to unsafe levels of impurities has prompted regulators to scrutinize impurities more critically than ever and regulatory actions related to impurities continue to grow.
Finding and addressing impurities earlier in R&D and process development can reduce the risk of unsafe impurity levels later in manufacturing processes, helping you stay on time and in compliance with regulatory expectations.