Key Takeaways
- The International Council for Harmonisation has issued its long-awaited Q1 guideline on the stability testing of drug substances and drug products for public consultation.
- The guideline brings together and significantly updates the ICH’s stability guideline series Q1A-F and Q5C into a single, harmonized document.
- The draft Q1 guideline includes recommendations for studies managed within the pharmaceutical quality system, supports alternative approaches, and addresses new technologies and strategies for enhanced product understanding.
The International Council for Harmonisation is inviting stakeholder feedback on its keenly-awaited guideline that explains how sponsors can apply science- and risk-based principles to the stability testing of drug substances and drug
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