Certifying Pharmaceutical Exports An Introduction To FDA's Certificate Of Pharmaceutical Product
Certifying Pharmaceutical Exports: An Introduction To FDA's Certificate Of Pharmaceutical Product By Michael Cooper, Clinical and Regulatory Affairs, Pharmatech Associates When exporting human drugs, manufacturing facilities are often asked by foreign customers or governments to provide documentation of the facility’s compliance with FDA standards. FDA issues export certificates for approved or licensed drugs and for unapproved drugs that meet certain legal requirements. Certificates of pharmaceutical product (CPP) are issued for human drugs exported from the U.S. directly to the requestin...