<1> Injections and Implanted Drug Products (Parenterals)—Product Quality Tests
The U.S. Pharmacopeial Convention (USP) aims to have drug substance and product monographs in the United States Pharmacopeia and the National Formulary (USP–NF) compendia for all drug products and their ingredients that are legally marketed in the United States. To support a drug product monograph, USP has divided the tests of a monograph into two categories: product quality tests and product performance tests—both arising from an understanding of critical quality attributes for a named article. Taxonomy in the USP–NF categorizes dosage forms according to five routes of administration: injection, oral, topical-transdermal, mucosal, and inhalation. For each route of administration, USP has/will create two general chapters: one that provides product quality tests that can be called out in a monograph, and one that provides one or more product performance tests that also can be called out in a monograph.
Based on these considerations, USP–NF General Chapter <1> Injections is being revised to contain only product quality tests for injections and implanted drug products (parenterals); this revision was recently published for public comment in Pharmacopeial Forum 39 (5), September–October 2013.
- Overview of USP dosage form taxonomy
- Discussion of revised <1>, content and structure
- Industry Perspective
This workshop will be offered in a hybrid format whereby participants can attend face-to-face (limited availability) or via WebEx. Please select your preference via the online registration form. Details on your preferred attendance will be provided one (1) week prior to the event.
- Analytical chemistry
- QA/QC analysis
- Regulatory affairs
- Contract research organizations
- Contract manufacturing organizations
- Packaging manufacturers and suppliers
- Government agencies and laboratories
This workshop will be offered in a hybrid format whereby participants can attend face-to-face (limited availability) or via WebEx. Please select your preference via the online registration form. Details on your preferred attendance will be provided in your registration confirmation email.
There are no registration fees associated with this workshop, however registration is required. Please utilize the Registration Button on this page to register for the workshop and receive relevant information for your participation.