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

HumanScientific guidelines

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 It has been superseded by ICH Q5B, ICH Q5D and ICH Q6B.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

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