| Synopsis: |
This is a record of the deliberations and recommendations of an expert committee commissioned by WHO to co-ordinate a range of research and other activities needed to ensure that biological products conform to international standards of purity, potency, safety and stability. Addressed to manufacturers, researchers and national control authorities, the report also provides updated information about the availability of international biological standards and reference reagents, which are established by WHO and held and distributed by the four international laboratories for biological standards.The report has three main parts, the first of which consists of brief comments on a number of topics relevant to the development of international reference materials available and the use of different assays in quality control. The second part announces changes in the status of international reference materials for various antibiotics, antibodies, antigens, blood products, endocrinological substances and cytokines. It also summarizes the status of candidate reference materials and alerts the research community to products requiring additional evaluation before an acceptable international standard can be established. The most extensive part of the report includes detailed requirements for the manufacturing and licensing of Haemophilus type b conjugate vaccines and inactivated influenza vaccine.The book also establishes guidelines for the quality assurance of pharmaceutical and biological products made using recombinant DNA techniques. |