The challenges of interpreting pharmacopeia

Beccy Bell, associate director of Laboratory Services at testing and regulatory consultancy Broughton, outlines the challenges of interpreting the guidance, and measures that can be put into place to ensure pharmaceutical products are compliant with the guidance outlined in several jurisdictions.  

Pharmacopeias contain the official standards for the quality of substances in medicines and how to make them. There are four Pharmacopeias: British, European, U.S. and Japanese. While the four sets of standards are largely harmonised, there are nuances that are open to…