(2002; 166 pages)
Regulatory experience in Argentina
Dr Marina Rossi, Argentina
ANMAT (Administracion Nacional de Medicamentos, Alimentos y Tecnologia Medica) is the national regulatory authority in Argentina. It is responsible for ensuring the quality, safety and efficacy of drugs for human use. Although plasma-derived products are considered as pharmaceutical products in Argentina, blood and blood components, are not. The national blood system is responsible for ensuring the quality and safety of blood and plasma used for fractionation. There are two plasma fractionation facilities in Argentina.
Regulations on good manufacturing practices for products derived from human blood or human plasma were prepared in 1997-1998 by ANMAT, based on the guidelines established by WHO and the European Union. The document consists of two parts:
1. Good manufacturing practices: general requirements, including recommendations on the manufacture and quality control of plasmaderived products.
2. Guide for inspections of manufacturers and importers of plasmaderived products.
The requirements and inspection items are formated as questions in a checklist. Each question is ranked as imperative, necessary, recommendable or informative. A written inspection report should summarize the main aspects of each inspection, give general information about the facilities, and indicate any deficiencies. Each copy of the report should be signed by the inspectors and the responsible person of the plant. One copy of the report is given to the company.
Depending on the inspectors’ report, the responsible authority may:
• temporarily withdraw an establishment’s licence,
• require approval of the work programme,
• issue a certificate of compliance with GMP.
For imported plasma-derived products, inspection of the importers covers only the following items:
• general information,
• storage areas,
• returned products,
• product recall,
• quality control,
• quality assurance.
Each imported consignment of plasma-derived product should be accompanied by the documentation:
• batch release certificates,
• plasma source certificate,
• criteria used to exclude donors with a risk factor for new variant CJD.
Mercosur/Southern Common Market (1994) is a treaty that establishes a common market between Argentina, Brazil, Paraguay and Uruguay. The Blood Products Commission of Mercosur has prepared some harmonized documents including:
• technical requirements for production and quality control of human plasma products (1999): general requirements (GMP) and quality control of albumin, immunoglobulins, factor VII, factor VIII, factor IX and prothrombin complex; and
• guide for inspection of manufacturers and importers of plasma-derived products (2001).
The above documents will be proposed for approval by each member state.