Starting Materials and Intermediates

This position statement addresses to what extent any variability may be acceptable in the early manufacturing steps for biological medicinal products which contain active substance extracted from organs, tissues or fluids from living organisms, either of animal or plant originiii and for which flexibility of sourcing in the biological starting materials may be needed to ensure product supply. This document also clarifies the definition of starting materials for these products. A number of major examples are given which illustrate the concept of accepting process variability. The principles outlined in this document could be applied to other biological medicinal products for which flexibility of sourcing in the biological starting materials may be needed, e.g. porcine pancreas for insulin and pancreatin, and allergens. Advanced Therapy Medicinal Products (ATMP) are excluded from the scope of this document.

To get more detailed information please also read the "Reflection paper on the use of starting materials and intermediates collected from different sources in the manufacturing of biological medicinal products"

The paper was adopted by the Committee for medicinal products for human use for release for consultation. The consultation deadline is 31 August 2013. If you want to provide comments please send those to alberto.ganan@ema.europa.eu using this template.

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