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Focus Areas
- Standards for packaging systems and their materials of construction (metal, glass, plastic and elastomeric)
- Packaging definitions; definitions for the proper storage of compendial articles
- Guidance on procedures and controls for the proper distribution of compendial articles
- Guidance on good packaging and repackaging practices
Expert Committee Charge
- The General Chapters–Packaging and Distribution Expert Committee is responsible for developing new and revising existing general chapters related to packaging (container-closure systems), storage, and distribution of pharmaceutical ingredients or dosage forms.
Key Issues
- Modernization of General Chapter <87> Biological Reactivity, In Vitro and General Chapter <88> Biological Reactivity, In Vivo
- Modernization of General Chapter <381> Elastomeric Closure for Injections; including methods and specifications for the various elastomeric materials
- Modernization of General Chapter <660> Containers–Glass; including the replacement of titration methods with quantitative methods
- Continued work on the updating and development of new plastic standards
- Development of a general chapter dealing with metal containers
- Development of general chapters on various Good Distribution Practices topics
Subgroups and Expert Panels
- Container materials—packaging/glass/plastic/elastomers
- Packaging performance and compatibility
- Packaging development/integrity
- Extractables and leachables
- Packaging/repackaging
- Biocompatibility
- Good distribution practices
Standards Development
- The latest ballot results can be found here (results can be filtered by particular ECs).
- The status of Revisions, Deferrals, Cancellations, Commentary, and Index for each USP–NF and Supplement can be found here.
Contact
- Desmond Hunt, Ph.D., Principal Scientific Liaison - General Chapters, dgh@usp.org
- Allison von Berg, M.F.S., J.D., Expert Committee Manager, abv@usp.org