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

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Current effective version

Adopted guideline

Reference numberCPMP/ICH/365/96
Published01/09/1999
Effective from01/09/1999
KeywordsSpecification, biological products, biotechnological products, characterisation, purity, impurities, contaminants, quantity, reference standard, process control, identity, potency
DescriptionThis 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.


Document history

First version

Current version

Adopted guidelineIn operation: 01/09/1999–present
Superseded documentAdopted guidelinePublished: 31/12/1994


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