WHO Expert Committee on Biological Standardization
Forty-sixth Report
Technical Report Series, No 872
World Health Organization
ISBN-13    9789241208727 ISBN-10    9241208724
Order Number    11000872
Price    CHF    20.00 / US$    24.00 Developing countries:    CHF    14.00
English     1998        97   pages
Presents the recommendations of a WHO expert committee commissioned to coordinate a range of research and other activities needed to ensure that biological products conform to international standards of purity, potency, safety, and stability. Work includes the establishment of detailed requirements for the manufacturing, licensing and control of vaccines and other biologicals, and the development of guidelines for good manufacturing practice. The committee also coordinates the establishment of international biological reference materials for use in clinical assays, pharmaceutical research, and quality control.
The report has three parts. The first provides a brief discussion of general issues that shape the committee's work. The second part summarizes changes in the status of some 39 biological reference preparations and candidate preparations in the categories of antibiotics, antibodies, antigens, blood products, cytokines, endocrinological and related substances, and toxins. Reference materials are established by WHO and held and distributed, for use in the standardization and control of biologicals, by four international laboratories for biological standardization.
The third and most extensive part issues detailed new requirements for the manufacturing and control of hepatitis A vaccine (inactivated) and revised requirements for the manufacturing and control of hepatitis B vaccine prepared from plasma. The report also includes detailed guidelines for the regulation and licensing of biological products in countries with newly developing regulatory authorities. The guidelines are intended to help control authorities establish mechanisms for ensuring the safety, quality, and efficacy of biologicals, whether imported or manufactured locally.