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

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  • OCABR batch release certificates

OCABR batch release certificates

28 November 2014

As part of the Institute’s commitment to continual improvement, NIBSC is delighted to announce that we be offering manufacturers the option to receive your OCABR certificates electronically from spring 2015. This means that your certificates will arrive even more quickly. Whilst feedback from manufacturers suggests that this will be very popular, you will have the option to continue to receive paper certificates by post if you wish. Please watch out for e-alerts from NIBSC requesting confirmation of your preferences and contact details.

In the meantime, we have prepared some guidelines to help us to help you receive ‘error-free’ OCABR certificates.

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:

  • 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.

For further information about NIBSC’s OCABR testing services please email us 

 
 
 
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