USP Forms Elemental Impurities Advisory Group - Pharmaceutical Technology

Latest Issue
PharmTech

Latest Issue
PharmTech Europe

USP Forms Elemental Impurities Advisory Group


The US Pharmacopeial Convention (USP) has formed the Elemental Impurities Implementation Advisory Group and appointed members to the group from various regulatory agencies. The group will recommend implementations and general chapter adjustments to USP and will report to the Chemical Analysis Expert Committee.

According to USP, the Advisory Group was formed in accordance with the Bylaws of the USP Convention, which state, “The EVP–CEO may appoint advisory bodies to advance the work of the Council of Experts and the Convention and provide advice to staff on policy matters.” 

Dr. Roger Williams, EVP–CEO and Chair, Council of Experts, appointed the following members to the group:

  • Jon Clark, FDA
  • David Gaugh, GPhA
  • John Kauffman, FDA and ICH Q3D Rapporteur (current)
  • David Klug, IPEC–Americas
  • John Leighton, FDA
  • Robert Osterberg, USP Toxicology Expert Committee
  • John Punzi, CHPA
  • Mark Schweitzer, ICH Q3D Rapporteur (through Step 2)
  • Phyllis Walsh, NJPQCA 

USP will keep stakeholders informed through web postings on the Elemental Impurities Key Issues page, including summaries of the Advisory Group’s deliberations.

ADVERTISEMENT

blog comments powered by Disqus
LCGC E-mail Newsletters

Subscribe: Click to learn more about the newsletter
| Weekly
| Monthly
|Monthly
| Weekly

Survey
FDASIA was signed into law two years ago. Where has the most progress been made in implementation?
Reducing drug shortages
Breakthrough designations
Protecting the supply chain
Expedited reviews of drug submissions
More stakeholder involvement
Reducing drug shortages
70%
Breakthrough designations
4%
Protecting the supply chain
17%
Expedited reviews of drug submissions
2%
More stakeholder involvement
7%
View Results
Eric Langerr Outsourcing Outlook Eric LangerRelationship-building at Top of Mind for Clients
Cynthia Challener, PhD Ingredients Insider Cynthia ChallenerRisk Reduction Top Driver for Biopharmaceutical Raw Material Development
Jill Wechsler Regulatory Watch Jill Wechsler Changes and Challenges for Generic Drugs
Faiz Kermaini Industry Insider Faiz KermainiNo Signs of a Slowdown in Mergers
From Generics to Supergenerics
CMOs and the Track-and-Trace Race: Are You Engaged Yet?
Ebola Outbreak Raises Ethical Issues
Better Comms Means a Fitter Future for Pharma, Part 2: Realizing the Benefits of Unified Communications
Better Comms Means a Fitter Future for Pharma, Part 1: Challenges and Changes

Click here