The International Council for Harmonisation (ICH) on 17 April issued its long-awaited update of its Q1 guideline on stability testing of drug substances and drug products. The new guideline ...
The International Council for Harmonisation (ICH) has adopted its M12 guidance, which promotes a harmonized approach in conducting and interpreting enzyme- or transporter-mediated in vitro and ...
The ICH E20 guideline, released as a Step-2 draft in June 2025, establishes globally harmonised principles for the planning, conduct, analysis, and interpretation of ...
The degree of formality in a risk management process should be customized to the organization’s particular needs and the risks involved. The International Council for Harmonisation’s (ICH) Q9 Quality ...
Analytical characterization is vital for product quality, manufacturing control, and regulatory compliance in biopharmaceutical development. ICH Q6B outlines structural characterization requirements, ...
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