CDER Requests Access to Drug Manufacturing Operations

The FDA is asking pharma companies to open their doors and allow CDER staff to observe manufacturing operations as part of its internal training program.

The agency wants its project managers to have a better understanding of manufacturing operations first-hand, and is asking companies to allow groups of CDER staff to tour their facilities, the agency said in a Federal Register notice scheduled to be published Feb. 9.

The primary purpose of the Site Tours Program is for project managers to learn about the team approach to drug development, including drug discovery, preclinical evaluation, tracking mechanisms and regulatory submission operations.

The program is not intended as a mechanism to inspect, assess, judge or perform a regulatory function, but is meant “to improve mutual understanding and to provide an avenue for open dialogue,” the agency says. CBER recently announced a similar training program for biologics manufacturing operations. Read the notice here: www.fdanews.com/02-08-16-SiteTrainingProgram.pdf.