Vaccine Standards

Standards Updates

Documentary Standards Associated Reference Standards
<198> Nuclear Magnetic Resonance Spectroscopy Identity Testing of Bacterial Polysaccharides Used in Vaccine Manufacture PS NMR System Suitability (Released)

Pharmacopeial Forum Updates

Documentary Standards Status
<1239> Vaccines for Human Use – Viral Vaccines (NEW)

<1234> Vaccines for Human Use – Polysaccharide and Glycoconjugate Vaccines

<1235> Vaccines for Human Use – General Considerations

<1238> Vaccines for Human Use – Bacterial Vaccines
Due to be published in PF 44(5) on Sep 4, 2018, comments due Nov 30, 2018)

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General Chapters Biological Analysis Expert Committee

The General Chapters – Biological Analysis Expert Committee, in addition to its other responsibilities, is charged with the development and revision of vaccine General Chapters which provide a high level overview relevant to all vaccines, bacterial and viral. Sitting below these in the hierarchy will be a series of product class chapters, for different groups of bacterial or viral vaccines, of which currently one is official. These product class chapters will provide detailed information on the manufacturing procedures, intermediates, in-process tests, release tests and expectation values for critical quality attributes. For each product class it is also intended to develop a series of analytical method chapters containing validated protocols to determine the appropriate critical quality attributes. One such chapter, <198> Nuclear Magnetic Resonance Spectroscopy Identity Testing of Bacterial Polysaccharides Used in Vaccine Manufacture, is currently open for public comment in the latest issue of the Pharmacopeial Forum.

Review the committee's workplan and learn more. Your feedback and questions are always welcome at vaccines@usp.org