2U.S. Department of Health and Human Services, Food and Drug Administration, Center for Drug Evaluation and Research (CDER), et al. Guidance for industry sterile drug products produced by aseptic processing -Current Good Manufacturing Practice [EB/OL]. http://www.fda.gov/ downloads/Drugs/.
3European Commission. Volume 4 EU Guidelines to Good Manufacturing Practice Medicinal Products for Human and Veterinary Use Annex 1 Manufacture of Sterile Medicinal Products (corrected version) [EB/OL].[2008-11-25]. http:// ec.europa.eu/health/files/eudralex/vol-4/2008 11 25_gmp- anl_en.pdf.
