Revision of USP <1235> Vaccines for Human Use - General Considerations

In the 2. supplement  of USP 33,  the revised General chapter <1235> "Vaccines for Human Use - General Considerations" was released on 30 June 2010. It becomes official on 1 February 2011. 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.

For manufacturing a vaccine, an overall plan for manufacturing should provide the following factors:

  • Physical Facilities
  • Raw materials and process aids
  • Actual manufacturing process including the initial process (production of Virus/bacteria and recombinant materials) and the downstream processes (purification or chemical modification, if applicable)
  • Antigen modifications
  • Storage of process intermediates and final bulk
  • in-process and final product testing regimens and controls schemes
  • Addition of adjuvants
  • Formulation and filling
  • Container closure systems
  • Stability programme that supports the dating period of the product

The overall goal is to produce a save and effective vaccine. For his life cycle, quality systems are necessary to support the manufacturing process development:

  • Specifications for raw materials, process intermediates and final product
  • change control, failure investigations and complaints

So chapter <1235> provides considerations to

  • Overall Manufacturing Plan
  • Seed Lot Systems
  • Fermentation and Cell Culture Media
  • Propagation and Harvest
  • Purification
  • Intermediates
  • Final Bulk
  • Final Container
  • Evaluating the Stability of Vaccines
  • Nomenclature
  • Labeling
  • Lot  Release Testing
  • and in the Appendices 1 and 2 the types of currently licensed vaccines in US and selected regulatory documents

The ECA Course GMP for Vaccine Manufacturers in Heidelberg, Germany  from 13 to 15 October 2010 provides you with an insight into the GMP requirements of vaccine manufacturing.

Axel H. Schroeder
On behalf of the European Compliance Academy (ECA)

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