Hepatitis A vaccine or combined vaccines that contain hepatitis A and Typhoid or Hepatitis B, are tested at NIBSC for batch release purposes. The testing carried out is potency and identity testing and is used at NIBSC to assay final vaccine or final bulks of inactivated Hepatitis A vaccines. The manufacturer’s vaccine protocol is also reviewed as part of the OMCL batch release process.

Testing is carried out as per Ph Eur monograph 01/2008:1107

NIBSC participates in PTS (Proficiency testing studies) for the EDQM.

We Participate in both global and European Collaborative studies, to establish Standards.

The laboratory was responsible for establishing the current International Standard (IS) 95/500 for use in Antigen Assays.

NIBSC has helped to draft the OMCL guidelines for Hepatitis A.