Q6B: Specifications : Test Procedures and Acceptance Criteria for Biotechnological/Biological Products

Regulatory Resource: Q6B: Specifications : Test Procedures and Acceptance Criteria for Biotechnological/Biological Products

Description:

The tripartite harmonised ICH guideline was finalised (Step 4) in March 1999. This document provides guidance on justifying and setting specifications for proteins and polypeptides which are derived from recombinant or non-recombinant cell cultures. The scope of this part is initially limited to well-characterised biotechnological products, although the concepts may be applicable to other biologicals as appropriate. In view of the nature of the products, the topic of specifications include in-process controls, bulk drug, final product and stability specifications and give guidance for a harmonised approach to determining appropriate specifications based on safety, process consistency, purity, analytical methodology, product administration and clinical data considerations.

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