Use of starting materials and intermediates collected from different sources in the manufacturing of non-recombinant biological medicinal products

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Current effective version

Adopted guideline

Reference numberEMA/CHMP/BWP/429241/2013
Published12/07/2013
Effective from01/12/2013
KeywordsStarting materials, sourcing, intermediates, heparins, urine derived products, plasma derived medicinal products, manufacturing process
DescriptionThis document clarifies the definition of starting materials for specific groups of biologicals. It presents CHMP’s current position on the use of variant processes in early manufacturing stages of these products.


Document history

First version

Current version

Adopted guideline


Overview of comments


Draft reflection paper

In operation: 01/12/2013-present


Published: 10/06/2013


Published: 31/05/2012


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