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Vaccine quality
Biological medicinal products differ from chemical drugs in that they cannot normally be characterized molecularly; starting methods such as bacteria, viruses, or genetically modified micro-organisms are of enormous complexity, as well as having the capacity to vary from preparation to preparation. A certain amount of these products, such as vaccines against transmissable disease, are also administered to healthy individuals -- often children at the start of their lives, and thus a strong emphasis must be placed on their quality to ensure, to the greatest extent possible, that they are efficacious in preventing or treating life-threatening disease, without themselves causing harm.
The increasing globalization in the production and distribution of these biological medicines has opened new possibilities to better manage public health concerns, but has also raised questions about the equivalence and interchangeability of medicines procured across a variety of sources. International standardization of starting materials, of production and quality control testing, and the setting of high expectations for regulatory oversight on the way these products are manufactured and used have thus been the cornerstone for their continued success. But it remains a field in constant change. The continuous technical advances in the field offer a promise of developing potent new weapons against our oldest public health threats, as well as new ones - malaria, genetic deficiencies, pandemic influenza, and AIDS, to name a few -- but also put a great pressure on manufacturers, regulatory authorities, and the wider medical community to ensure that products continue to meet the highest standards of quality attainable.
Production and Quality: WHO Specifications
Biological medicinal products, such as vaccines, blood and blood products, diagnostics, gene therapy, biotechnology products, cytokines and growth factors, and cell and tissue products rely heavily on international standardization to ensure their quality and their equivalence across manufacturers. For over a half-century, WHO has been active in the field of biological standardization, bringing together scientists and policy makers on a global scale to find consensus approaches to the manufacturing, testing and regulatory oversight of these medicinal products. Through the WHO Technical Report Series (TRS) up-to-date methods are described for the benefit of its Member States and manufacturers, and international reference materials for the standardization of assays and testing are established through collaborative studes for global distribution. Consultations and expert working groups on technical issues important to the field are also documented, giving interested parties the latest information available on complex issues such as biocontainment of potential pandemic threats, clinical and non-clinical testing of vaccines, risks of transmissible spongiform encephalopathies (TSE's), DNA vaccines, and a variety of other topics.
VACCINES AND IMMUNIZATION PRACTICES
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WHO position papers
RELATED LINKS
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Biologicals
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Global Training Network on Vaccine Quality (GTN/VQ)
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Prequalification of vaccines
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Product Information Sheets (PIS)
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Vaccine manufacturers' corner
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Introduction of 10-day electronic temperature monitoring devices for international vaccine shipments
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Vaccine vial monitors (VVM)
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Immunization home
HIGHLIGHTS
WHO Technical Report Series: 941
Full text [pdf 3.60Mb]
WHO Expert Committee on Biological Standardization (ECBS) 2007
Meeting reports
UPCOMING EVENTS
WHO/Health Canada Consultation on New Pneumococcal vaccines
7-8 July 2008, Ottawa, Canada
WHO Expert Committee on Biological Standardization (ECBS)
13-17 October 2008, Geneva, Switzerland
RECENT PUBLICATIONS
2007
WHO Working Group meeting on standardization of Acellular Pertussis Vaccines: potency assay, Beijing, China
Download [pdf 278kb]
WHO Study Group on Cell Substrates for production of biologicals, Geneva, Switzerland
Download [pdf 312kb]
WHO/Health Canada consultation Vaccine Lot Release, Ottawa, Canada
Download [pdf 210kb]
WHO Working Group meetings on revision of the manual of lab. methods for testing DTP vaccines, Geneva, Switzerland
Download [pdf 223kb]
WHO: working to ensure global QUALITY, SAFETY AND STANDARDS in immunization
Download
WHO Study Group on Cell Substrates for production of biologicals, Geneva, Switzerland
Download [pdf 312kb]
WHO Workshop in training reference of Rotavirus vaccine potency testing, NIBSC, Potters Bar, UK
Download [pdf 144kb]
WHO Workshop on standardization of Pneumococcal Opsonophagocytic Assay, Geneva, Switzerland
Download [pdf 248kb]
CONTACTS
Immunization, Vaccines and
Biologicals
World Health Organization (WHO)
Avenue Appia
CH-1211 Geneva
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