Impurities found in pharmaceuticals are a cause for concern. By definition, impurities are any components that are not active ingredients or excipients, and that can compromise quality in a drug substance or product. Pharmaceutical impurities can be classified as organic or inorganic and include residual solvents. The presence of impurities results from manufacturing and degradation processes. Unacceptable levels of impurities in drug substances or drug products can indicate inadequate understanding and control of the production process, as well as insufficient stability testing and quality control measures. It is important to know your impurities to help minimize the threats they can pose to public health and to avoid product recalls.
This year, United States Pharmacopeia (USP) Asia Pacific (APAC) organised a special outreach and education programme on the topic of impurities. USP held several events and shared resources and guidelines on how to deal with impurities. The programme included a Live Webcast, and a three-day USP Education Online Course led by Dr Christian Zeine from USP’s Scientific Affairs Team. Both events were an opportunity to share more about USP’s collective approach to impurities and how USP’s General Chapters, Reference Standards and Pharmaceutical Analytical Impurities (PAIs) are designed to support manufacturers in monitoring and controlling the level of impurities in their products.
The programme received strong interest in our community. Over 100 participants joined the course, including formulators, analytical and manufacturing scientists, regulators, and quality assurance and control professionals. All took an active part in the discussion through the Question & Answer (Q&A) Session and posed some important questions which led USP to look deeper into the knowledge gaps around impurities in the region.
In response to the insights shared by our community, and to answer remaining questions on this topic, USP is planning a second outreach and education programme later this year where we will investigate many of the remaining knowledge and technical gaps on impurities, including Nitrosamines.
In this programme, USP will offer additional learning and exchange opportunities focusing on how to report unspecified impurities, calculating total impurities, impurities in vaccines, and nitrosamines. Throughout this programme, we will share news on upcoming developments of USP reference standards and how these could be used optimally. We hope to offer a series of interactive online and in-person courses with structured Q&A opportunities, real examples, and case studies in several APAC languages, as well as further guidance on monograph development and interpretation.
Should you have further questions, please contact our USP APAC team: