Traditionally, pharmacopoeia is a book of medicinal drugs with their effects and directions for use. Today, the pharmacopoeia are regional organizations devoted to creating and maintaining standards to ensure public health. Part of that mission includes maintaining a list, or compendium, of those standards, which also cover dietary supplements, excipients used in drug manufacturing, food safety, and chemicals, and standards for drug manufacturing. The USP also has standard reference materials for use in compendial testing and performs research to update existing standards and create new ones. The EP and JP are primarily focused on providing a compendial reference document applicable for drugs manufactured for sale in Europe and Japan, respectively. The Council of Europe publishes the EP and makes standard reference materials available. All three organizations work together to harmonize key standards to decrease the global complexity of manufacturing and distributing drugs. The compendia are critical references for test methods used to release excipients and drug substance for use in manufacturing human use drugs and for maintaining quality during Current Good Manufacturing Practice (cGMP) manufacturing. Use of and reference to these standards is a key part of an effective cGMP compliance strategy.
You can learn more about making a generic drug in this recent blog post.
Reach out to me if you want to know more or discuss your medical product development challenges.
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Text Copyright © 2020 Katrina Rogers
