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.