Production and quality control of animal immunoglobins and immunosera for human use

  • Email
  • Help
Current effective version

Adopted guideline

Reference numberEMA/CHMP/BWP/3354/1999
Published04/08/2016
Effective from01/09/2016
KeywordsImmunoglobulins, antibodies, animal sera, immunosera, anti-sera, anti-toxin, quality control, viral, TSE safety
DescriptionThis is a technical update to reflect current best practice with regard to implementation of 3Rs approaches and it is not intended as a full revision of this guideline (only sections1, 3 and 6 are affected). In addition, minor changes have been introduced to reflect the new Agency templates, for example addition of an Executive Summary. All these changes are considered to be minor and uncontroversial and consequently a consultation phase was considered to be unnecessary.


Document history

Revision 1

Current version

Adopted guideline


 

Published: 04/08/2016

Effective date: 01/09/2016

 

First versionAdopted guidelineIn operation: 01/07/2009–31/08/2016

Related content


How helpful is this page?

Average rating:

 Based on 0 ratings

Add your rating:

See all ratings
0 ratings
0 ratings
0 ratings
0 ratings
0 ratings
    

Tell us more