Good manufacturing practice for immunological veterinary medicinal products

被引:3
作者
Todd, J. I. [1 ]
机构
[1] Vet Med Direct, Addlestone KT15 3LS, Surrey, England
来源
REVUE SCIENTIFIQUE ET TECHNIQUE-OFFICE INTERNATIONAL DES EPIZOOTIES | 2007年 / 26卷 / 01期
关键词
directive; 91/412/EEC; 2001/82/EC; good manufacturing practice; immunological veterinary medicinal products; veterinary vaccine;
D O I
10.20506/rst.26.1.1732
中图分类号
S85 [动物医学(兽医学)];
学科分类号
0906 ;
摘要
Good manufacturing practice (GMP) is applied to the manufacture of immunological veterinary medicinal products (IVMPs) in a number of regions around the world. Within the European Union (EU) there are well-established requirements for GMP in the manufacture of IVMPs. Maintaining GMP when producing IVMPs is important because there are particular risks associated with their manufacture. These risks concern contamination and cross-contamination, environmental and operator protection, the variability of biological manufacturing processes and the limitations of some IVMP finished product tests. Whilst the general requirements of GMP are applicable to all medicinal products, guidance which addresses the specific concerns for IVMPs is provided by Annex 5 and also Annex I in Medicinal Products for Human and Veterinary Use: Good Manufacturing Practice (referred to as the GMP Guidelines). Extending and harmonising GMP requirements for IVMP manufacture throughout the world will increase the availability of high quality, safe and efficacious IVMPs.
引用
收藏
页码:135 / 145
页数:11
相关论文
共 10 条
  • [1] [Anonymous], 2001, Official Journal of the European communities, VL311, P1
  • [2] *EDQM, 2005, EUR PHARM, P460
  • [3] *EUR COMM, 1991, OFF J EUR COMMUNIT L, V228, P70
  • [4] *EUR UN, 2006, RUL GOV MED PROD EUR
  • [5] *EUR UN, 2004, OFF J EUR UNION C, V24, P6
  • [6] European Parliament European Council, 2004, OFF J EUR UNION, V136, P58
  • [7] Luff P., 1997, VET VACCINOLOGY, V2nd ed., P201
  • [8] *OIE, 2000, MAN DIAGN TEST VACC
  • [9] *PHARM INSP CONV P, GUID GOOD MAN PRACT
  • [10] Tellez Sonia, 2006, Vaccine, V24, P1710, DOI 10.1016/j.vaccine.2005.12.037