Vaccines and plasma-derived medicines intended for human use must be safe. One needs to be able to trust that every vaccine or plasma-derived medicine has exactly the same composition. An independent control for each batch of vaccines and plasma-derived medicines is therefore required by law. This is regulated by the Netherlands Medicines Regulation.

Each batch of vaccines or plasma-derived medicines is therefore tested by an independent National Medicines Control Laboratory (OMCL). In the Netherlands, the OMCL is part of RIVM. Once all tests have been carried out correctly and achieved good results, RIVM issues a batch release certificate, which is valid throughout the European Union. 

How does RIVM test vaccines and plasma-derived medicines for a batch release? 

Based on the production and control protocols, RIVM checks whether the manufacturer has produced the batch in accordance with the requirements described in the registration dossier and in the European Pharmacopoeia. In addition, samples from the batch are tested for quality in an independent laboratory examination. 

Consistent quality is more difficult for biological medicines 

For vaccines and plasma-derived medicines, product consistency is more difficult to achieve and ascertain than for chemical drugs. This is because both the starting material (cells, viruses, plasma) and the production process (fermentation, fractionation) are biological in nature and therefore entail more variation. Also, the tests needed to check the product are complex and differ from each other, which makes it difficult for the manufacturer. As a result, it is likely that a batch will show deviations, such as reduced efficacy or contamination with viruses, bacteria or toxins.  

If a faulty product enters the market, consequences can be great, both for the individual and for public health. For vaccines, quality and safety are important as they are used, among other things, in the National Vaccination Programme. 

Facts and figures about the batch release by RIVM 

The RIVM's OMCL for biological medicines is part of the European OMCL network. RIVM tests an average of 500 batches of vaccines and 150 batches of plasma-derived medicines per year. To do so, RIVM has a well-equipped laboratory, which is accredited according to ISO (International Organization of Standardization) / IEC 17025. 

European network 

Up until the early 1990s batch release was mainly carried out nationally, so a batch destined for several (European Union) Member States was to be tested by several OMCLs. When new European directives were issued, this came to an end. It is legally established that when a batch has been released by another (EU) Member State, this batch release must be recognised. This prevents a batch from being tested by several Member States. This saves significant costs and time for both governments and manufacturers.  

The Official Control Authority Batch Release (OCABR) network has been established within the European Union to build trust on each other's batch release results. This network covers all EU Member States, as well as Norway, Iceland and Switzerland. It is is coordinated by the Council of Europe's European Directorate for the Quality of Medicines (EDQM). Within the network, procedures are agreed to achieve harmonised working methods.  

In principle, a manufacturer can offer its products to any OMCL in the European Union for batch release. All authorities work in accordance with the European directive and recognise thereof the batch release certificates that are issued. The test results are exchanged on a confidential basis. Due to the transparent procedures and the mutual recognition of batch release certificates, the European system is seen by the WHO as best practice. European procedures and guidelines can be downloaded via the EDQM. 

Official Control Authority Batch Release (OCABR) 

Batch release request forms: