FDAnews Drug Daily Bulletin

ISPE Works to Find Consensus Between Industry and FDA on Quality Metrics

Sept. 13, 2013
The International Society for Pharmaceutical Engineering (ISPE) is searching for common ground between the FDA and industry on quality metrics, which the agency believes can improve drug quality and drugmakers contend will only cause confusion. The goal is to develop a white paper acceptable to industry and regulators that defines objective metrics for use in a risk-based inspection program.

The project started during a June ISPE conference where attendees at a workshop voiced lingering questions about the challenges surrounding quality metrics, including:

  • Should they be measured by site, product or company?

  • Does the metric truly reflect quality and/or compliance? and

  • Would their wider use lead to unacceptable behavior by industry or regulators?

John Avellanet will speak on the issue during FDAnews’ Eighth Annual FDA Inspections Summit, Oct. 23-25.