| Good manufacturing practice for immunological veterinary medicinal products. | |
| | |
MedLine Citation:
|
PMID: 17633298 Owner: NLM Status: MEDLINE |
Abstract/OtherAbstract:
|
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. |
| | |
Authors:
|
J I Todd |
Related Documents
:
|
8291078 - How to lead and manage employees. 19297838 - Solar panels make really good cents. 10244628 - A hat-trick of model teams. 18509738 - Typology, classification and management issues of greek lakes: implication of the water... 14612258 - Humanities in full retreat. 7436308 - Negligence and the surgeon. |
Publication Detail:
|
Type: Journal Article; Review |
Journal Detail:
|
Title: Revue scientifique et technique (International Office of Epizootics) Volume: 26 ISSN: 0253-1933 ISO Abbreviation: Rev. - Off. Int. Epizoot. Publication Date: 2007 Apr |
Date Detail:
|
Created Date: 2007-07-17 Completed Date: 2007-08-23 Revised Date: - |
Medline Journal Info:
|
Nlm Unique ID: 8712301 Medline TA: Rev Sci Tech Country: France |
Other Details:
|
Languages: eng Pagination: 135-45 Citation Subset: IM |
Affiliation:
|
Veterinary Medicines Directorate, Woodham Lane, New Haw, Addlestone, Surrey KT15 3LS, United Kingdom. |
Export Citation:
|
APA/MLA Format Download EndNote Download BibTex |
| MeSH Terms | |
Descriptor/Qualifier:
|
Animals Drug Contamination European Union Legislation, Drug* Legislation, Veterinary* Risk Factors Vaccines / standards* Veterinary Medicine / standards* |
| Chemical | |
Reg. No./Substance:
|
0/Vaccines |
From MEDLINE®/PubMed®, a database of the U.S. National Library of Medicine
Previous Document: Antigen and vaccine banks: technical requirements and the role of the european antigen bank in emerg...
Next Document: Innate immunity and new adjuvants.