Contact
- Desmond Hunt, Ph.D., Principal Scientific Liaison - General Chapters, dgh@usp.org
Interested in learning more about the work of this Expert Committee?
Download Roster Observe a Meeting
Upcoming Official Meetings
- October 4, 2019 face-to-face meeting at USP–U.S., Rockville, MD
Past Meetings – Executive Summaries
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 Good Distribution Practices
Subgroups and Expert Panels
- Container materials – packaging/glass/plastic/elastomers
- Packaging performance and compatibility
- Packaging development/integrity
- Medical devices/extractables and leachables
- Packaging/repackaging
- Toxicology
- Good distribution practices
Ballot Results and Standards-Development
Historic Prospectus
- <381> Elastomeric Closure for Injections (posted 30–Dec–2016; deadline 30–Jan–2017)
- <382> Elastomeric Closure Functionality in Injectable Pharmaceutical Packaging/Delivery Systems (posted 30–Dec–2016; deadline 30–Jan–2017)
- <1381> Evaluation of Elastomeric Components Used in Pharmaceutical Packaging/Delivery Systems (posted 30–Dec–2016; deadline 30–Jan–2017)
- <1382> Assessment of Elastomeric Closure Functionality in Injectable Pharmaceutical Packaging/Delivery Systems (posted 30–Dec–2016; deadline 30–Jan–2017)