Extraneous agents testing for substrates of avian origin and viral vaccines for poultry: Current provisions and proposals for future approaches

Biologicals - Tập 38 - Trang 362-365 - 2010
Carmen Jungbäck1, Andreas Motitschke2
1Paul-Ehrlich-Institut, Langen, Germany
2Paul‐Ehrlich‐Institut, Langen, Germany

Tài liệu tham khảo

Commission Directive 92/18/EEC of 20 March 1990 modifying the Annex to Council Directive 81/852/EEC on the approximation of laws of Member States relating to analytical, pharmacotoxicological and clinical standards and protocols in respect of the testing of veterinary medicinal products (O.J. No L 97 of 10.4.92). Commission Directive 91/412/EEC of 23 July 1991 laying down the principles and guidelines of good manufacturing practice (GMP) for veterinary medicinal products (O.J. No L 228 of 17.8.91). Council Directive 88/320/EEC of 7 July 1988 on the inspection and verification of good laboratory practice (GLP), (O.J. L 145, 11.06.1988). Directive 2001/82/EC of the European Parliament and of the Council of 6 November 2001 on the Community code relating to veterinary medicinal products (O.J. No. L 311 of 28.11.04). Directive 2004/28/ec of the European Parliament and of the Council of 31 March 2004 amending Directive 2001/82/EC on the Community code relating to veterinary medicinal products (O.J. L 136 of 30.4.04). 1971 1991 1997 2002 2005 2008 Validation of analytical procedures, PA/PH/OMCL (05) 47 DEF, www.edqm.eu. June 2005. Validation of analytical procedures: Definition and Terminology, VICH GL 1. www.vichsec.org. October 1998. Validation of analytical procedures: Methodology, VICH GL 2. www.vichsec.org. October 1998.