Tracing and control of raw materials sourcing for vaccine manufacturers

Biologicals

Volumn 38, Issue 3, 2010, Pages 352-353

  Faretra Peysson, Laurence ^a  

^a BD Diagnostics Diagnostic Systems   (France)

Author keywords

Audit; Control; Quality systems; Supply chain; Traceability

Indexed keywords

VACCINE; VETERINARY DRUG;

ARTICLE; CULTURE MEDIUM; DIAGNOSTIC TEST; DRUG MANUFACTURE; GOOD MANUFACTURING PRACTICE; MEDICAL INFORMATION; PRION DISEASE; PRIORITY JOURNAL; QUALITY CONTROL; VACCINE PRODUCTION; VIRAL CONTAMINATION; VIRUS INFECTIVITY;

ANIMALS; DRUG CONTAMINATION; DRUG INDUSTRY; GUIDELINES AS TOPIC; HUMANS; QUALITY CONTROL; TECHNOLOGY, PHARMACEUTICAL; VACCINES;

EID: 77952959156     PISSN: 10451056     EISSN: 10958320     Source Type: Journal    
DOI: 10.1016/j.biologicals.2010.01.011     Document Type: Article

References (4)

1. International Organization for Standardization ISO 9001 http://www.iso.org/iso/fr/iso_catalogue/management_standards.htm%23.
2. GMP Institute Good manufacturing practices http://www.gmp1st.com/gmp.htm.
3. EMEA 410/01 rev 02 Note for Guidance on minimizing the risk of transmitting animal spongiform encephalopathy defined by the Committee for Proprietary medicinal products (CPMP) and by the Committee for veterinary medicinal products (CVMP). Official Journal of the European Union 2004.
4. European Pharmacopoeia 6th edition Chapter 5.2.8 Minimising the risk of transmitting animal spongiform encephalopathy agents via medicinal products 2008, Council of Europe, Strasbourg, 558-67.