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Tag Archives: Good Manufacturing Practices
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
Posted in Argentina, Uncategorized
Tagged Active Pharmaceutical Ingredients, ANMAT, API, Argentina, drug products, electronic submission, GMP, Good Manufacturing Practices, inspections, Latin America, National Regulatory Agency of Regional Reference, new Disposition, regulatory affairs, Site Master File, SMF
2 Comments
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
Posted in Mexico
Tagged COFEPRIS, GMP, GMP certificate, Good Manufacturing Practices, health authority, inspecitions, Latin America, Mexico, regulatory affairs
6 Comments
Regulatory Affairs in Latin America 