Bovine serum - Regulatory issues

Developments in Biologicals

Volumn 123, Issue , 2006, Pages 269-272

  Robertson, J S ^a  

^a NATIONAL INSTITUTE FOR BIOLOGICAL STANDARDS AND CONTROL   (United Kingdom)

Author keywords

9CFR; Bovine polyoma virus; Bovine serum; EU guidelines

Indexed keywords

BIOLOGICAL PRODUCT;

ANIMAL; BIOSYNTHESIS; CATTLE; CONFERENCE PAPER; DRUG LEGISLATION; EUROPE; HUMAN; ISOLATION AND PURIFICATION; POLYOMA VIRUS; PRACTICE GUIDELINE; SAFETY; SERUM; STANDARD; UNITED KINGDOM; UNITED STATES; VIROLOGY;

ANIMALS; BIOLOGICAL PRODUCTS; CATTLE; EUROPE; GREAT BRITAIN; HUMANS; LEGISLATION, DRUG; POLYOMAVIRUS; PRACTICE GUIDELINES; SAFETY; SERUM; UNITED STATES;

EID: 33644616919     PISSN: 14246074     EISSN: None     Source Type: Book Series    
DOI: None     Document Type: Conference Paper

References (8)

1. U.S. Code of Federal Regulations, Title 9, Part 113.53, Requirements for ingredients of animal origin used for production of biologies.
2. th Edition, Chapter 5.2.3, Cell Substrates for the Production of Vaccines for Human Use.
3. The Rules Governing Medicinal Products in the European Union, Volume 7B, Guidelines for Veterinary Medicinal Products, Immmunologicals, Quality (http://pharmacos.eudra.org/F2/eudralex/download/ volpdf/vol7/vol7ben.pdf).
4. CPMP/BWP/1793/02. CPMP Note for Guidance on the Use of Bovine Serum in the Manufacture of Human Biological Medicinal Products (http://www.emea.eu.int/ pdfs/human/bwp/179302en.pdf).
5. EMEA/CVMP/743/00. CVMP Guideline on Requirements and Controls Applied to Bovine Serum Used in the Production of Immunological Veterinary Medicinal Products, (http://www.emea.eu.int/pdfs/ vet/iwp/074300.pdf).
6. European Pharmacopoeia PA/PH/Exp. BSR/T (03) 1 COM, Bovine Serum (draft).
7. th edition. Basic requirements for viral safety of biotechnological/biological products listed in Japanese Pharmacopoeia. JP Forum 2003;12(1):3-17.
8. Sanco/C3/AH/R21/2000. European Commission, DG Sanco, Scientific Committee on Animal Health and Animal Welfare, "Virus inactivation in bovine blood and blood products".