Guidance for manufacturers of biological medicines - independent batch release in the United Kingdom following the UKs departure from the EU.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).
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.
We give a high priority to testing biological medicines both in terms of its importance for public health and as a service to the biopharmaceutical industry. 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. Our product testing is accredited to the ISO17025 quality standard by the UK Accreditation Service. We endeavour to keep our certification fees as low as possible.Help us to help you receive ‘error-free’ OCABR certificates
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.
We have an on-going programme of service improvement. We have recently implemented a secure gateway to enable companies to submit batch release paperwork online and are currently developing a state-of-the-art laboratory information management system (LIMS) to improve efficiency. From spring 2015 manufacturers will have the option to receive your OCABR certificates electronically.
The staff performing the testing are experts in their field and maintain their expertise through relevant research projects and collaborations. Product testing is carried out in well-equipped, purpose-built laboratories in Hertfordshire on the outskirts of London.
If you are interested in batch release or other product testing services and would like more information please contact us.