An accurate and good understanding of the contents of any pharmaceutical or biopharmaceutical helps to ensure both drug efficacy and patient safety. This is no revelation. In fact, this was recognised almost 200 years ago when the United States Pharmacopeia (USP) was formed, with the very aim of specifying the minimum level of critical quality attributes that should be controlled throughout the manufacture of drug substances (DS) and drug products (DP) and their shelf-life.
These attributes and respective acceptance criteria, as well as associated test methods, are described in the monograph of an article. When a test procedure is used in multiple monographs, the preferred option is to develop a General Chapter for this procedure, which is referenced in the various monographs. USP is believed to be the oldest continuously revised and published pharmacopoeia. Their “book” is the USP-National Formulary (USP-NF), which focuses on DS and DP for prescription and over-the-counter drugs, dietary supplements and ingredients, excipients and compounded DP. Ensuring that the almost 5000 monographs within the USP-NF today are correct, up-to-date and make use of the most appropriate and current existing technology involves the work of a large team comprising staff, regulatory agencies, committees, expert panels, the pharmaceutical industry and other stakeholders. In this article, we will explore the area of pharmacopoeial monograph modernisation, including thoughts and input from USP staff and industry experts, considering relevant and upcoming chromatographic and spectroscopic techniques.
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