GMP inspections: regulatory aspects

When is a GMP inspection from ANMAT necessary?

For drug product manufacturing sites, when they are not located in an Annex I country, and are not already certified by an Annex I country. (for a list of Annex I countries, see this page) The GMP requirement is drug product-specific, meaning that the product of interest must be stated in the certificate for it to be accepted.

Agreement among MERCOSUR countries: when a drug product is manufactured in a country member of the MERCOSUR, other MERCOSUR countries may publish and officially recognize as own GMP certificates issued by the manufacturer country. By experience, I can assert that this happens in many cases between Argentina and Brazil.

MERCOSUR countries: Argentina, Brazil, Paraguay, Uruguay, Venezuela, Bolivia (in process of becoming a full member).

Application for inspection by ANMAT: required documents

  • Written request
  • Copy of ANMAT authorization to requestor
  • Information on manufacturer/s
  • Site Master File
  • Site authorization from Health Authority in country in which it is located
  • List of pharmaceutical forms manufactured in site
  • List of drug substances manipulated in site
  • List of pharmaceutical forms by drug substances to import
  • Information and documents on third parties involved in manufacturing or control
  • Fee

Last update: October 2013


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