USP Workshop—Visual Inspection of Parenterals Advisory Panel Webinar

This free interactive, online clarified several comments received in response to the PF Stimuli Article 35(5) [Sept–Oct 2009] "Visible Particulates in Injections–A History and a Proposal to Revise USP General Chapter Injections <1>." It provided the opportunity for early input and comments to preliminary concepts and ideas affecting future standards—specifically the applicability of the proposed inspection technique and limits to large volume parenterals, lyophilized and powder injections, biotechnology protein-based injections; and confusion relative to the term "product in distribution"; differences regarding inspection for "intrinsic" and "extrinsic" visible particles; and the stability and shelf-life implications of the test.

Topics:

  • Proposed inspection procedure and conditions for large volume parenterals composed
    of flexible packaging
  • Product in distribution sample size of 60 units
  • Increase in number of samples required and testing costs
  • Clarification of "product in distribution"
  • Drugs that require reconstitution with a vehicle, emulsions or suspensions
  • Visual inspection of protein injections
  • Distinction between "intrinsic" and "extrinsic" visible particulate matter
  • Particle growth during the shelf-life of biotechnology–derived products

When: May 13, 2010

Where: Live session at USP Headquarters in Rockville, MD, USA, transmitted live online
via WebEx

Agenda

Presentations: Webinar presentations

Participants: Professionals working in or with

  • Manufacturing: Managers, Supervisors
  • R&D: Managers, Supervisors
  • Engineers
  • Validation
  • Quality