FDA Proposes Amendment of GLP for Non-Clinical Laboratory Studies

The FDA has proposed significant changes to the Good Laboratory Practice (GLP) for Non-Clinical Laboratory Studies in order to be more relevant to today’s practices in regards to the way studies are planned and conducted. The proposed changes especially focused on multi-site studies. 

According to the National Law Review, the following are included among the significant proposed changes by the FDA: 

  • Additional standard operating procedures (SOP) to ensure conformity with the proposed requirement for a GLP Quality System;
  • Revised definitions of "testing facility" and "test site" to address the functions and requirements unique to multi-site studies; and
  • Updated responsibilities assigned to key roles in a GLP study, including but not limited to the Sponsor, Management, Study Director, Quality Assurance Unit, Principal Investigators, and contributing scientists.