Good Manufacturing Practice (GMP)
The quality system standards governing the manufacture, packaging, and testing of medicinal products.
What it means
GMP certificates and inspection reports are required exhibits for LATAM marketing authorizations. They are typically issued in the manufacturer's country language and translated for filing. ANVISA additionally issues its own GMP certificates (CBPF) after on-site inspection.
Why it matters for LATAM submissions
GMP documents carry proper names of facilities, addresses, and product forms. Translation errors in these fields are the ones regulators refuse to accept even in an errata.
Relevant regulators
ANVISACOFEPRISANMATINVIMADIGEMIDARCSAISPMINSA
Related terms
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