WHO Recommendations, Guidelines and Other Documents Related to the Manufacture and Quality Control of Biological Substances Used in Medicine. WHO Expert Committee on Biological Standardization, Sixty-fifth Report; WHO Technical Report Series No. 993, 2015, Annex 1
(2015; 5 pages)

Abstract
WHO Recommendations, Guidelines and other documents are intended to provide guidance to those responsible for the production of biological substances used in medicine as well as to others who may have to decide upon appropriate methods of assay and control to ensure that products are safe, reliable and potent. WHO Recommendations (previously called Requirements) and Guidelines are scientific and advisory in nature but may be adopted by an NRA as national requirements or used as the basis of such requirements. All WHO Recommendations, Guidelines and other documents on biological substances used in medicine are formulated by international groups of experts and are published in the WHO Technical Report Series.
 
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