In the section of In-process revision of the Pharmacopeial Forum 34/5 the USP published a new draft of general information in the General chapters <1235> "Vaccines for Human Use - General Considerations". It provides background information on vaccine manufacturing and tests for individual vaccine monographs in USP. This text includes information relative to U.S. requirements and references to requirements in other countries.
Despite the multiple forms of vaccines, like bacterial vaccines, viral vaccines, DNA-based vaccines (under development) and the high number of other vaccine components, like adjuvants, the chapter focuses on commonalities throughout the manufacturing process, from raw material qualification to final release tests. The general requirements for vaccines are listed in national laws and international guidances like 21CFR sections 200 and 600, or in ICH (International Conference on Harmonization) or WHO (World Health Organization) guidelines. In USA vaccines are regulated by FDA as biological products, and you can find additional recommendations in FDA points to consider and guidance documents.
The ECA Course GMP for Vaccine Manufacturers in Prague, Czech Republic, from 28-30 October 2009 provides you with an insight into the GMP requirements of vaccine manufacturing.
Axel H. Schroeder
On behalf of the European Compliance Academy (ECA)