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 of Active Pharmaceutical Ingredients (APIs).

This new checklists are based in ICH guidelines and include several items of the following aspects: Administration and General Information, Human Resources, Building Structure and Installments, Services Systems, Computarized Systems, Documents and Registers, Material Management, Production and in-Process Controls, Conditioning and Labeling of APIs and Intermediate Products, Storage and Distribution, Quality Control, Validations, Change Management, Rejection and Reutilization of Materials, Complaints and Market Recalls, Contract Manufacturers and QC Labs, Agents, Intermediates, Marketers, Distributors, Repackagers, APIs obtained by Cell Culture of Fermentation Methods, APIs for use in Clinical Trials and Quality Assurance.

The Disposition also includes the potential measures to be applied in case of deficiencies, from programed corrective measures to close-down of the facilities, indicating which deficiencies will bring what outcomes.


About Maria I. Guaia
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