Loading, please wait...

product description page

Who Expert Committee on Biological Standardization : Sixty-sixth Report (Paperback)

Who Expert Committee on Biological Standardization : Sixty-sixth Report (Paperback) - image 1 of 1

About this item

This report presents the recommendations of a WHO Expert Committee commissioned to coordinate activities leading to the adoption of international recommendations for the production and control of vaccines and other biological substances, and the establishment of international biological reference materials.

Following a brief introduction, the report summarizes a number of general issues brought to the attention of the Committee. The next part of the report, of particular relevance to manufacturers and national regulatory authorities, outlines the discussions held on the development and adoption of new and revised WHO Recommendations, Guidelines and guidance documents. Following these discussions, a WHO guidance document on Regulatory assessment of approved rDNA-derived biotherapeutics was adopted along with WHO Guidelines on the stability evaluation of vaccines for use under extended controlled temperature conditions and on WHO good manufacturing practices for biological products. In addition, revised WHO Recommendations to assure the quality, safety and efficacy of recombinant human papillomavirus virus-like particle vaccines were also adopted by the Committee.

Subsequent sections of the report provide information on the current status and proposed development of international reference materials in the areas of antibiotics; biotherapeutics other than blood products; blood products and related substances; in vitro diagnostic device reagents; and vaccines and related substances.

A series of annexes are then presented which include an updated list of all WHO Recommendations, Guidelines and other documents on biological substances used in medicine (Annex 1). The above four WHO documents adopted on the advice of the Committee are then published as part of this report (Annexes 2-5). Finally, all additions and discontinuations made during the 2015 meeting to the list of International Standards, Reference Reagents and Reference Panels for biological substances maintained by WHO are summarized in Annex 6. The updated full catalog of WHO International Reference Preparations is available at: http://www.who.int/bloodproducts/catalogue/en/.
Number of Pages: 286
Genre: Medical
Series Title: Who Technical Report
Format: Paperback
Publisher: Stylus Pub Llc
Language: English
Street Date: July 6, 2016
TCIN: 51560773
UPC: 9789241209991
Item Number (DPCI): 248-24-9759
If the item details above aren’t accurate or complete, we want to know about it. Report incorrect product info.

Guest reviews

Prices, promotions, styles and availability may vary by store & online. See our price match guarantee. See how a store is chosen for you.