Tag Archives: GMP

Argentina: Site Master File now required by ANMAT for national sites

Starting on November 19th, 2o13, sites in Argentina approved by ANMAT to manufacture or package, in own or contract facility, or import or export, both drug products and APIs, have to submit their Site Master Files (SMF) annually. This is … Continue reading

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Argentina: checklist for GMP inspections of API facilities

On the 3rd of September 2013, ANMAT (regulatory agency in Argentina) issued a new Disposition establishing the guidelines and checklists that will be used by its inspectors for GMP inspections of sites of manufacturing, elaboration, fractionating, distribution, commercialization, exports and imports … Continue reading

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Mexico: new guidelines for the acceptance of GMP certificates

In October 2013, the Mexican health authority released a new document setting the criteria that will be used to accept GMP certificates as valid. This criteria applies to certificates of manufacturing facilities both of finished products and API. Summary of … Continue reading

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