Good manufacturing practice for immunological veterinary medicinal products.

Abstract

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 1 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.