2015–2020 General Chapters–Packaging and Distribution Expert Committee Work Plan

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

• March 21-22, 2018
• March 21-22, 2018
• June 22–23, 2016
• July 22, 2015

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

• View Expert Committee monograph and general chapter assignments (EXCEL).

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)