NIBSC performs OCABR testing for biological medicines

 

NIBSC acts as the UK’s OMCL and the Institute batch release tests biological medicines for the European market. The analytical tests and document controls performed by NIBSC are laid down in the Official Control Authority Batch Release (OCABR) guidelines.   If the batch of the product meets specification then NIBSC will provide the manufacturer with an EU/EEA OCABR certificate. 

 

OCABR testing at NIBSC is carried out by world experts. Some areas in which NIBSC has specialist expertise includes safety testing for childhood vaccines and plasma pools.  OCABR testing of childhood vaccines has additional safety issues compared with many products given that the products will be administered to large numbers of healthy infants and children.

 

NIBSC's OMCL duties are an essential aspect of the Institute’s dedication to improving public health and this means that OCABR testing is prioritised accordingly.  NIBSC is commited to customer service and is sensitive to the need for manufacturers to have the certification process carried out as quickly and efficiently as possible, without the compromising the standard of testing.

 

All of NIBSC’s OCABR tests have either formal ISO 17025 accreditation or are undergoing formal accreditation, in particular as new tests are introduced.

 

Some biological medicines which do not require formal batch release testing are still monitored to check their quality. NIBSC also tests products which are already released onto the market and may also be involved in testing of products should a problem arise such as failure of correct storage conditions or an adverse reaction in patients.

 

Tell me what tests are currently available.

 

If we do not currently perform the test that you require or for further details on OCABR testing at NIBSC please contact us.