Glossary

CBPF (ANVISA GMP Certificate)

The Certificado de Boas Práticas de Fabricação, ANVISA's GMP certification issued after inspection.

What it means

CBPF (Certificado de Boas Práticas de Fabricação) is issued by ANVISA after an on-site GMP inspection of a manufacturing site. Foreign facility submissions supporting CBPF issuance must be filed in Brazilian Portuguese with a TPIC-certified translation.

Why it matters for LATAM submissions

A CBPF is a gating requirement for many ANVISA registrations. Translation gaps in the Site Master File extend the inspection dossier review.

Relevant regulators

ANVISA

Related terms

Translating this concept for a submission?

Send one document to Amavita and we'll return it with the correct terminology, certification, and formatting for the regulator you're targeting. No charge, no commitment.

Start your LATAM pilot