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

Current effective version

ICH: Q 6 B: Test procedures and acceptance criteria for biotechnological/biological products - Step 5

Adopted Reference Number: CPMP/ICH/365/96 Legal effective date: 01/09/1999

Document history - First version (current)

ICH: Q 6 B: Test procedures and acceptance criteria for biotechnological/biological products - Step 5

Adopted Reference Number: CPMP/ICH/365/96 Legal effective date: 01/09/1999

Superseded document

Production and quality control of medicinal products derived by recombinant dna technology

Adopted Reference Number: 3ab1aen Legal effective date: 01/07/1995