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規制ガイダンス
WHO
世界保健機関（WHO）
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WHOの生物製剤に関するQuality Assurance and Safetyのホームページでは、生物製剤の製造・管理および関連するin vitro診断検査に関するWHOの規制および技術ガイダンス、基準および規範が示されています。
| タイトル | タイプ | 公示日 | |
|---|---|---|---|
| Recommendations for the Production and Quality Control of Inactivated Influenza Vaccine (inactivated) | WHO Recommendations | February 2005 | |
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The Recommendations are based on the outcome of an informal WHO consultation held at Ferney Voltaire, France in July 2003 during which suggested amendments to the currently published version (last revised 1990, WHO technical report series no. 814) had been discussed. The Committee was reminded of the significant developments in influenza vaccines since the last revision of the document. Subunit and split vaccines are now widely used and the effective dose of haemagglutinin has been established. In addition vaccines containing adjuvants have been developed and approved. The danger exists of pandemics caused by the appearance of novel and highly pathogenic strains of virus and this danger presents a number of challenges for production and administration of suitable vaccines. The new recommendations available at the website below reflect these and other developments. |
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| Requirements for the Use of Animal Cells as in vitro Substrates for the Production of Biologicals | WHO Recommendations | February 2005 | |
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View PDF Amendment to the Recommendations for the use of animal cells for the in vitro production of biologicals. The WHO Requirements for the use of animal cells as in vitro substrates for the production of biologicals (WHO technical report series no. 878, 1998, Annex 1) provide, inter alia, information about a WHO cell bank of vero cells. These cells were developed in 1987 and designated as a Master Cell Bank in 1998. Cultures of the cells are available to manufacturers and national control authorities. The Committee had been informed of possible deficiencies in the records relating to the cell bank that might have regulatory implications for establishment of master cell banks, and so a revision of the Requirements was proposed. The amendment agreed by the Committee endorsed a recommendation from a WHO cell bank monitoring group that the 10-87 Vero cell bank should not be considered as a master cell bank for direct use in manufacturing processes. Rather, the 10-87 bank should be regarded as a cell seed qualified by scientific analytical consensus from which master cell banks (MCBs) may be established for thorough re-qualification. Addendum: http://www.who.int/biologicals/Amendment_Cell_Substrates_ECBS_Nov_2003.pdf |
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