WHO Expert Committee on Biological Standardization. Forty-fifth report

This report presents the recommendations of a WHO Expert Committee commissioned to coordinate activities leading to the adoption of international requirements for the production and quality control of vaccines and other biologicals and the establishment of international biological reference materials. The report starts with a discussion of general issues brought to the Committee's attention and provides information on the status and development of reference materials for various antibiotics, antibodies, antigens, blood products, cytokines, endocrinological and related substances and toxins. The second part of the report, of particular relevance to manufacturers and national control authorities, contains guidelines on the regulation and licensing of biological products in countries with newly developing regulatory authorities, new requirements for hepatitis A vaccine (inactivated) and revised requirements for hepatitis B vaccine prepared from plasma.

Published by World Health Organization technical report series, 1995. The guideline itself is at the source linked here.

pubmed.ncbi.nlm.nih.gov/8650946/