GMP Certification
GMP Certification
GMP Certification
Inspection Requirements
• The majority of Latin American countries follow the WHO GMP requirements.
• Argentina, Brazil, Colombia and Mexico enforce their own inspection and GMP certification regimes (including international inspections for API and Finished Product).
• Bolivia, Chile, Costa Rica, Dominican Republic, Guatemala, Nicaragua, Panamá, Perú, Puerto Rico, Venezuela and others accept foreign GMP certifications.
• Brazilian GMP certification is mandatory for product registration approval.
• Argentina, Colombia and Mexico accept GMP certifications from high vigilance countries (i.e. USA, Europe, etc.).
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