ICH Q6B Specifications: test procedures and acceptance criteria for biotechnological/biological products - Scientific guideline

This document proposes a uniform set of international specifications for biotechnological and biological products to support new marketing applications. The principles adopted and explained in this document apply to proteins and polypeptides, their derivatives, and products of which they are components.

Keywords: Specification, biological products, biotechnological products, characterisation, purity, impurities, contaminants, quantity, reference standard, process control, identity, potency