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The United States Pharmacopeia (USP) continuously creates and revises standards in response to industry needs to keep up with the evolving pharmaceutical landscape. Recently, there has been a surge in revisions of USP chapters centered on the evaluation of packaging components for drug products.
The table below provides an overview of the various chapters, and required tests for parenteral packaging components. It also highlights the chapters that are under revision as of February 2018. As indicated in the table, numerous packaging chapters were revised or created, but publication has recently been cancelled to allow strategic redevelopment based on the industry comments received.
West regularly monitors and supports the development of USP packaging chapters to ensure compliance, so dialogue with a Technical Customer Service representative can serve as a valuable resource to help drug companies understand requirements and upcoming changes. In addition, the USP website releases general announcements and intends to revise notices at least monthly to help inform of compendial activity.
On January 1, 2018, new USP standards became mandatory for measuring elemental impurities in pharmaceuticals and their ingredients – aligning with ICH Q3D, which provides limits for the amount of elemental impurities in drug products. New USP General Chapters, USP <232> (<em>Elemental Impurities – Limits</em>) and USP <233> (<em>Elemental Impurities – Procedures</em>) have replaced USP <231> (<em>Heavy Metals</em>). USP <231>, which historically was used to test for heavy metals in drug products as well as packaging components, has been withdrawn. However, the heavy metals testing in USP <381> (<em>Elastomeric Closure for Injections</em>), which is used for testing of elastomeric closures, still references USP <231>.
Understanding the different compendial and standards requirements, and how they influence the final delivery of parenteral drug products, is critical for ensuring patient safety. There are ongoing efforts to harmonize national pharmacopoeia and international standards, driven in large measure by the continuous technological developments in the pharmaceutical industry. Harmonization efforts can be treated differently depending upon the country and working group, and in some cases larger differences result. Staying aware of changes and differences can be a challenge.
The American Association of Pharmaceutical Scientists (AAPS) held its annual meeting and exposition in Denver, CO from November 13-16. This meeting continues to be a major event in the calendar of pharmaceutical scientists in academia, the industry, government and research institutions who come to participate in training events and focus group meetings, hear subject matter expert presentations, and network with customers and suppliers at the 3-day exposition.
As regulatory expectations increase, drug product manufacturers face increased pressure to produce products free of defects and minimize rejects of finished drug products. Particulate matter in finished pharmaceuticals can come from a number of sources, including the ingredients in the drug product, manufacturing equipment or the container closure system.
Compendial documents developed by both international and national organizations outline specifications for elastomeric components that are used in packaging of parenteral drug products. These specifications often are not harmonized; not all compendia specify the use of the same tests, and some tests that are used globally have varying specifications. Understanding these specifications and how they influence packaging/delivery of parenteral drug products in global markets is critical.
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