Excellent question. Furthermore, the EU provides GMP certificates for companies manufacturing investigational products, whereas the FDA doesn't typically inspect until the product is to be made commercial. So, if you are manufacturing investigational products to be used in clinical studies in the EU, from the US, do you need to obtain a GMP certificate from someone in the EU?
------------------------------
Don Rackham
Director Quality
Union City CA
United States
------------------------------
Original Message:
Sent: 09-Jul-2018 10:10
From: Gwendolyn Lohr
Subject: GMP Certificate and MRA
A number of countries globally request GMP certificates from my company for their submissions, and so far, the Danish health authority has inspected our US production sites and thereafter issued a GMP certificate for these sites. In the future however, they will no longer conduct these inspections, as they will accept the FDA inspection, and thereby we will no longer receive GMP certificates, because FDA does not issue them.
Instead FDA posts a publication "The Drug Establishments Current Registration Site" (DECRS) of currently registered establishments (facilities) which manufacture, prepare propagate, compound or process drugs that are commercially distributed in the US or offered for import to the US: https://www.accessdata.fda.gov/scripts/cder/drls/getdrls.cfm. But for some countries a link to DECRS is not sufficient.
How other companies are dealing with a similar issue?
------------------------------
Gwendolyn Lohr
United States
------------------------------