It 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 …

Jan 9, 1999 · This document proposes a uniform set of international specifications for biotechnological and biological products to support new marketing applications. The principles …

The ICH Q6A and Q6B are foundational guidelines, laying out the guiding principles for establishing specifications for drug substances and drug products that can be adopted …

It 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 …

ICH Q6A and Q6B were finalized in 1999. These guidelines address setting specifications for chemicals and some specific biological products, respectively. Develop the complementary …

Establishment of a single set of global specifications for new drug substances and products. Guidance on the setting and justification of acceptance criteria and the selection of test …

ICH draft guidance, Q6A Specifications: Test Procedures and Acceptance Criteria for New Drug Substances and New Drug Products: Chemical Substances, addresses specifications and …

Mar 1, 2016 · With this guideline on specifications and testing methods of new active substances and medicinal products ICH intends to make possible the compilation of a single specification …

Dec 15, 2013 · Specifications (test and acceptance criteria) for active pharmaceutical ingredients (APIs) and drug products are defined in ICH Q6A. It ‘establishes a set of criteria to which a …

Dec 23, 2024 · This article covers an ICH Q6(R1) concept paper aimed at revising principles for uniformity and consistency across certain ICH Q6 guidelines.