Q6A Specifications: Test Procedures and Acceptance Criteria for New Drug Substances and New Drug Products: Chemical Substances
The ICH Harmonised Guideline was finalized under Step 4 in October 1999. This document provides guidance on the setting and justification of acceptance criteria and the selection of test procedures for new drug substances of synthetic chemical origin, and new drug products produced from them, which have not been registered previously in the ICH regions.
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Date of Step 4: 6 October 1999
Status: Step 5
Guidelines (Click the links below for complete guidelines)
Other Document (Click the links below for complete guidelines)
Q6B Specifications: Test Procedures and Acceptance Criteria for Biotechnological/Biological Products
The ICH Harmonised Guideline was finalized under Step 4 in March 1999.
This document provides general principles on the setting and justification of a uniform set of international specifications for proteins and polypeptides which are produced from recombinant or non-recombinant cell-culture expression systems.
The scope of this part is initially limited to well-characterized 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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Date of Step 4: 10 March 1999
Status: Step 5
*These Guidelines Belongs to ICH website.
