Production and quality control of medicinal products derived by recombinant DNA technology - Scientific guideline

This document provides quality recommendation for medicinal products derived by recombinant DNA technology. It aims to facilitate the application of Part 2, section A-E of the annex to Directive 75/318/EC. It has been superseded by ICH Q5B, ICH Q5D and ICH Q6B.

Keywords: Recominant, DNA, rDNA, quality control,fermentation, purification, cell banking characterisation, biological potency, purity, specifications

Current effective version

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

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