Guidance for manufacturers of biological medicines - independent batch release in the United Kingdom following the UK’s departure from the EU.
Independent assurance of quality is important for maintaining public confidence in biological medicines. The NIBSC has the capability to test a wide range of products including:
All of our product testing is undertaken to ISO 17025 compliance under our externally assessed UK Accreditation Service (UKAS) ISO 17025 accredited Quality Management System.
The NIBSC is the UK’s official National Control Laboratory and is therefore responsible for carrying out independent batch release testing of biological medicines.
From 1 January 2021, Great Britain is no longer be subject to EU Directive 2001/83/EC (Article 114) and NIBSC is a stand-alone National Control Laboratory.
Detailed guidance for manufacturers related to independent batch release for Great Britain (England, Scotland and Wales) and Northern Ireland from 1 January 2021 is available here.
Turnaround times are calculated from when the last component of the batch, whatever that should be, arrives at the NIBSC from the manufacturer. NIBSC strives to deliver control testing certificates in a timeframe that is well below the legal requirement. The average turnaround time for releases conducted at the NIBSC during 2019 and 2020 was 3.9 days. The turnaround times are shown per product category in the following graph.
Since the middle of 2020, we have been setting up tests for the new COVID-19 vaccines. Due to the urgent public health need, we have managed our resources to ensure that our testing capacity keeps pace with increasing demand. Because the NIBSC recommends that independent testing of COVID-19 vaccines is performed by the NIBSC in parallel with manufacturer testing, where this occurs, the entire process of independent batch release typically adds only 1-2 days to the overall time needed for release of a batch to market.
Our actual turnaround times are shorter than both the legal, and our own reduced, self-imposed targets, provided in the table below.
The NIBSC strongly encourages manufacturers to submit batches for testing at the earliest opportunity, which in many cases means the testing can be performed in parallel. Once the finished protocol is received a certificate can be rapidly issued, provided the results for the batch comply with the agreed specifications. In this way, the NIBSC can often release certificates in 1 day.
For any queries please contact CPB@nibsc.org
The NIBSC recognises how important it is to manufacturers to receive accurate control testing certificates.
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 us 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.
Customers that currently do not have an account with the NIBSC for control testing may need to set one up with us. To do so, please contact Reference.Data@mhra.gov.uk with the following information;
Please note that this email address is only for setting up an account with the NIBSC. Please contact firstname.lastname@example.org for any other enquiries.
In addition to control testing, we test some biological medicines used outside the UK 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 low and middle income 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.