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 and viral infections
• albumins
• immunoglobulins
• therapeutic antibodies
• toxins and antitoxins
• blood clotting and anti-clotting factors
• plasma pools
• cytokines
• hormones and growth factors

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

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.

Since 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 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 turnaround times are shown per product category in the following graph:


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. 

The NIBSC strongly encourages manufacturers to submit batch samples for testing at the earliest opportunity, which in many cases means the testing can be performed in parallel to the manufacturer’s own quality testing. 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 ControlTesting@mhra.gov.uk.

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 ControlTesting@mhra.gov.uk for any other enquiries. 

Other control testing services

In addition to control testing for the UK market, 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.

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.