GMP inspections by COFEPRIS

GMP verification is required by COFEPRIS in the following cases:

• For new registration and manufacturing changes of biologic, biotech and hemoderivate products.

• For new registration or renewal of drug products or drug substances of any kind manufactured in countries not considered as high sanitary surveillance by COFEPRIS.

Inspection is required prior to submission (the certificate is an important document to be annexed to the submission dossier, it must be ready beforehand)

The sites that need this certification are all the anufacturing sites of drug substances and drug product – the certificate must be Drug Substance/Drug Product specific, meaning that the APIs and products of interest must be listed in the certificate.

The inspections can be conducted by the Health Authority or by a Third Authorized Party.

COFEPRIS also accepts certificates issued by the following countries, meaning that inspection by Mexico is not required if certification by these high-sanitary surveilliance countries is submitted: USA, Brazil, Canada, countries of the EU, Japan and Australia.

Mexico is currently participating in workgroups and has created taskforces to allow the possibility in the future of collaboration regarding GMP certification with other countries of the Pacific Alliance (Chile, Colombia, Costa Rica and Peru) and other Health Authorities of Regional Reference. (regulators from Argentina, Brazil, Colombia and Cuba)

Last update: October 2013