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

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Current effective version

Adopted guideline

Reference numberEMA/CHMP/BWP/3354/1999
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

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