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

Contact

Desmond Hunt, Ph.D., Senior Scientific Liaison - General Chapters, dgh@usp.org

Interested in learning more about the work of this Expert Committee?

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Upcoming Official Meetings

  • To be determined

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