Requirements for Hepatitis A vaccines (inactivated), Annex 2, TRS No 858
Requirements for Biological Substances No 49
25 May 1995
| Technical document
Overview
The isolation and propagation of HAV in cell culture were critical steps in the successful idevelopment of hepatitis A vaccines. These Requirements relate only to the production of hepatitis A vaccine (inactivated) in human diploid cells or continuous cell lines. If any other production process is used, different requirements may apply. Each of the following sections constitutes a recommendations. To facilitate internation distribution of vaccine made in accordance with these Requirements, an example of a summary protocol for recording the results of tests is provided as Appendix 1.
Full version of WHO Technical Report Series No. 858
WHO Team
Health Product Policy and Standards (HPS),
Norms and Standards for Biological Products (NSB),
Technical Standards and Specifications (TSS)
Number of pages
25
Reference numbers
WHO Reference Number: WHO TRS N°858
Copyright
World Health Organization