Guidance for manufacturers of biological medicines - independent batch release in the United Kingdom following the UK’s departure from the EU.
Customers that currently do not have an account with NIBSC for OCABR may need to set one up with us. To do so please contact Reference.Data@mhra.gov.uk who will be able to help. Please note that this email address is only for setting up an account with NIBSC and all other control testing enquiries should be sent to email@example.com
Biological materials used in medicine are typically very complex. They include vaccines made from bacterial or viral pathogens and products derived from human blood such as clotting factors and immunoglobulins.
Independent assurance of quality is important for maintaining public confidence in these products. NIBSC has the capability to test a wide range of biological medicines including:
NIBSC serves as the UK’s Official Medicines Control Laboratory (OMCL) for biological medicines. We perform official control authority batch release (OCABR) testing of blood products, vaccines and other biotherapeutics for the European market following guidelines of the European Directorate for the Quality of Medicines (EDQM).
All batches of vaccines and blood products for human use must be independently tested by a laboratory that is a member of the EU OCABR network. As the UK member of this network for human biological products, NIBSC is legally mandated to follow the EU Administrative Procedure for Official Control Authority Batch Release, referred to henceforth as control testing, following European Directives 2001/83/EC, amended by Directive 2004/27/EC, formerly Council Directives 89/342/EEC and 89/381/EEC.
We are committed to maintaining a consistently rapid, high-quality and cost-effective service with a focus on minimising the time between receiving samples and issuing release certificates.
The above guidelines detail the legal framework for control testing including specific details on the time required for an OMCL to complete control testing of submitted batches.
The Directive states “Within the European Union, Official Control Authority Batch Release shall be completed by the OMCL within 60 days of receipt of the complete set which consists of the protocol and samples and the fees, where required.”
NIBSC have long recognised that this 60 day limit is not helpful to manufacturers in issuing control certificates and therefore we have self-imposed turnaround times to deliver control testing certificates. These are shown in the table below:
Since the start of these NIBSC self-imposed turnaround times in 2012, over 99.5% of all products have been released within our time frame. The specific details are in the graphs below which are for the actual releases performed by NIBSC.
It is important to understand how NIBSC calculates turnaround times. As noted in the EU Guidelines above, the clock starts only on “…receipt of the complete set which consists of the protocol and samples…”.
Therefore, the turnaround time clock used by NIBSC only starts when the LAST component of the batch, whatever that should be, arrives at NIBSC.
In order to speed up the certification process, NIBSC strongly encourage manufacturers to submit any batches for parallel testing. Here NIBSC would receive the biological components of the batch and these will be tested on arrival. Once the finished protocol is received then a certificate can be issued, providing biological testing has been completed to the appropriate specification. In this way, NIBSC can often release certificates after 1 day of turnaround.
If there are any queries on these data or how NIBSC calculates turnaround or on any other aspect of Control testing, please contact CPB@nibsc.org
NIBSC recognises how important it is to manufacturers to receive accurate OCABR certificates. We are pleased to report that when asked how often they find mistakes on their certificates made by NIBSC, the vast majority of manufacturers respond ‘Not at all’.
To help us further improve our accuracy we would like to remind you that you can help us to provide you with ‘error-free’ certificates by keeping NIBSC up to date with any changes that could impact on information that appears on the certificate.
Information that you should advise us of without delay includes changes to:
Please provide this information to your NIBSC scientific contact.
NIBSC sends out all its certificates electronically in pdf format by default, but we can also send paper copies if requested.
In addition to OCABR testing, we also test centrally authorised products (CAP) as part of a scheme run by EDQM. In addition to OCABR testing, we test some biological medicines used outside the EU and perform prequalification testing on behalf of the World Health Organisation (WHO) to ensure the quality of medicines purchased by United Nations (UN) agencies for use in developing countries.
We also carry out contract testing for various other organisations on request and have the expertise to investigate problems with products as they arise.
If you are interested in our product testing services and would like more information please contact us.