Remote Interactive Evaluations of Drug Manufacturing and Bioresearch Monitoring Facilities

Issue Date: October 26, 2023
Issued by: Center for Drug Evaluation and Research
Topic(s): Current Good Manufacturing Practice (CGMP), Pharmaceutical Quality
Status: Draft

Remote Interactive Evaluations of Drug Manufacturing and Bioresearch Monitoring Facilities

FDA is issuing this guidance to describe how we request and conduct voluntary remote interactive evaluations at facilities where drugs are manufactured, processed, packed, compounded, or held, and at drug facilities covered under FDA’s bioresearch monitoring (BIMO) program.

Download the Guidance Document