Skip to content
Medicines & Healthcare products Regulatory Agency
The National Institute for Biological Standards and Control

Confidence in biological medicines

  • Stay connected
  • Shopping Basket
  • Pay Now
  • Login / Register
  • Home
  • Products
  • Standardisation
  • Control testing
  • Science and research
  • Expert services
  • About us
  • Control testing price list
  • Independent batch release testing at the NIBSC
  • Shipping instructions for independent batch release testing
  • Home  /  
  • Control testing

Guidance for manufacturers of biological medicines - independent batch release in the United Kingdom following the UK’s departure from the EU.

Control testing - Information for manufacturers

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:

  • vaccines against bacterial, viral and parasitic infections
  • albumins
  • therapeutic antibodies
  • toxins and antitoxins
  • blood clotting and anti-clotting factors
  • plasma pools
  • cytokines
  • hormones and growth factors

All of our product testing is undertaken to ISO 17025 compliance under our UK Accreditation Service (UKAS) assessed Quality Management System.

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 our well-equipped, purpose-built laboratories in Hertfordshire on the outskirts of London.

Independent batch release of biological medicines in the United Kingdom

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


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.

Turnaround time targets


Our actual turnaround times are shorter than both the legal, and our own reduced, self-imposed targets, provided in the table below. 

Product areaTarget turnaround time – working days
Vaccines 40
Immunoglobulins & albumin 10
Clotting factors 15
Plasma pools 8

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

Shipping of samples to the NIBSC for independent batch release testing 


Please follow these instructions to help avoid any delays or failures in shipping.

Help us to help you receive ‘error-free’ certificates

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:

  • your Manufacturing Site Name and / or address
  • the Market Authorisation Holder’s details
  • the Plasma Master File
  • information provided in your protocol submission, such as the:
    • number of final containers
    • expiry date
    • country reference given as part of the pool number     

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.

New Customers – How to set up an account

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;

  • Full legal entity name (no abbreviations, trading styles or short names)
  • Headquarters address
  • Bill To/Invoicing address (If different from the Headquarters address)
  • Invoicing email address and contact name
  • Purchase Order No. (if applicable)

Please note that this email address is only for setting up an account with the NIBSC. Please contact cpb@nibsc.org for any other enquiries. 

Other control testing services

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.


     
     
     
    • Careers
    • Terms and conditions
    • Accessibility
    • Privacy notice
    • Cookies
    • Sitemap