ICH

ICH Guidelines on Impurities | A Simplified Breakdown

ICH Guidelines on Impurities | A Simplified Breakdown

Navigating through the complexities of ICH guidelines can be daunting for pharmaceutical professionals. Here’s a distilled comparison to clarify how these standards apply across different stages of drug development:   ICH Q3A & Q3B: Focus on organic and degradation impurities in new drug substances and products, emphasizing safe limits and identification protocols.   ICH Q3C:…