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-fourth Report; WHO Technical Report Series No. 987, 2014, Annex 1
(2014; 5 pages)

The Recommendations (previously called Requirements) and Guidelines published by WHO are scientific and advisory in nature but may be adopted by an NRA as national requirements or used as the basis of such requirements. These international Recommendations are intended to provide guidance to those responsible for the production of biological substances 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. Recommendations concerned with 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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