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

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Superseded document

Adopted guideline

Reference number3AB1A
Published31/12/1994
Effective from01/07/1995
KeywordsRecominant, DNA, rDNA, quality control,fermentation, purification, cell banking characterisation, biological potency, purity, specifications
DescriptionThis 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 It has been superseded by ICH Q5B, ICH Q5D and ICH Q6B.


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