González PM

Language: Spanish
References: 7
Page: 87-90
PDF size: 74.02 Kb.

ABSTRACT

In Mexico, requirements of quality control and specifications of pharmaceutical products are regulated by the national pharmacopeia, a legal document of the Ministry of Health, prepared by an expert committee enrolled by invitation, working as unpaid volunteers. A special committee has been devoted to regulations of human plasma products. The industry of plasma derivatives in the country is small, and most of the products are imported from developed countries with good systems for quality assurance. National regulations in Mexico are written on the basis of experience of the committee experts and are partly based on international regulations, mainly the European Pharmacopoeia, EMEA, the USP and CFR from the USA with general guidance from ICH and WHO. Manufacturers are kept abreast of the development of regulations and their opinions are taken into account when preparing the documents. The discovery of infectious diseases transmitted by plasma has introduced an important component to strengthen the precautions for safety and have been integrated in the regulations for improving the assurance of quality.

REFERENCES

1. SSA. Farmacopea de los Estados Unidos Mexicanos. Octava edición. México: SSA; 2005.

2. ICH of Technical Requirements for Registration of Pharmaceuticals for Human use. Recommended for adoption at Step 4 of the ICH process on 10 March 1999 by the ICH Steering Committee.

3. European Pharmacopoeia. Fourt edition. Monograph Nr; 2005. p. 853

4. EMEA. Evaluation of Medicines for human use EMEA/CHMP/VEG/134716/2004.

5. United States Pharmacopoeia (USP). Twenty-ninth edition; 2006.

6. US Code of Federal Regulations. Title 21 Blood Products.

7. Kistler P, Friedli H. Etanol precipitation. En: Curling M: Methods of plasma protein fractionation. New York: Academic Press; 1980.