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 stated in the new disposition 7066/13 that you can access here (in Spanish).

The file has to be submitted to the front desk of the National Institute of Medicines (INAME) in the format of a PDF file in a CD or DVD. Paper submissions are not required nor accepted. All critical changes to the SMF are to be notified with a new SMF.

Companies have 30 days from publication of the regulation to comply and present their SMF. For the annual submission, new SMFs have to be sent 12 months from the last submission.

An annex specifying the required content for the SMF is attached to the new regulation. Here, a general summary:

1 General information on the company
1.1 Company contact information
1.2 Authorized pharmaceutical activities
1.3 Other activities
2 Quality management system
2.1 Quality management system
2.2 Finished product release procedure
2.3 Supplier and contract management (Service and/or system providers, raw material manufacturers and others)
2.4 Quality risk management
2.5 Product quality revision
3 Personnel
3.1 Organigram
4 Installations and equipment
4.1 Installations
4.2 Equipment
5 Document management
6 Production
6.1 Categories of products
6.2 Process validation
6.3 Material and storage management
7 Quality control
8 Distribution, complaints and product recalls
8.1 Distribution
8.2 Complaints, product faults and product recalls
9 Self-inspections
10 Annexes


About Maria I. Guaia
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2 Responses to Argentina: Site Master File now required by ANMAT for national sites

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