Parenteral Products: Pharmacopeial Control of Containers, Storage and Distribution

摘要

National pharmacopeias, for example the U.S. Pharmacopeial Convention (USP), The Japanese Pharmacopoeia (JP), and The European Pharmacopoeia of the Council of Europe (EP), set quality standards for active pharmaceutical ingredients, drug products, excipients, packaging materials, labeling and storage conditions. The USP also has General Information chapters numbered above <1000> that contain no standards, tests, assays or other mandatory specifications with respect to Pharmacopeial articles, but provide information and guidance on a large variety of topics including packaging, storage and distribution practices. This article will concentrate on the quality control of container materials used for packaging parenteral products (glass, plastic and elastomers), good storage and shipping practices as well as providing an overview of new topics that the USP is developing relevant to parenteral products within the Packaging, Storage and Distribution Expert Committee for the 2010-2015 cycle.