ANISA operations in international inspections are to be bolstered by local and state health inspectors. As of now, Agency inspections in factories located abroad may be performed by local public health servants trained in Good Manufacturing Practices.

ANVISA Ordinance No. 571/2013, published on Wednesday (March 27), provides a list of names of servants operating in the National Health Surveillance System (SNVS), based in local and state health surveillance agencies, who are able to participate in international inspection teams for the agency in medicines, pharmaceutical ingredients and health products.

Decree No. 7930/2013, published in February this year, opened the possibility of servants from other federal agencies participating in international inspection teams set up by ANVISA. Based on the Decree, ANVISA published the Ordinance which provides a new opportunity for training local health inspectors in the field and extends the capacity to perform inspections in factories located in other countries.

To date, international inspections in the industries of other countries were performed by ANVISA servants only. Future international inspection teams will continue to be led by the Agency's servants, but may include participation from inspectors who operate under local and state governments, provided they are authorized by the local health authority.

The criteria used in the selection process took into consideration the ability of professionals to communicate in English, the Good Manufacturing Practices (GMP) course provided by ANVISA and previous experience of industrial production process inspection. Local and state servants participating in international health inspection teams will be subject to ANVISA and Federal Public Administration rules and regulations with regard to the granting of travel and accommodation and related expenses.

In ANVISA, the General Office of Inspection, Quality Monitoring, Control and Surveillance of Inputs, Medicines, Products, Advertising and Publicity (GGIMP) will perform the activities required to enable the participation of the designated servants, in addition to increasing the number of qualified servants. As other inspectors who meet the requirements are identified, the Ordinance may be updated to include the new names.

03 April 2013