GRIP-Pharma

The ICH Q14 guideline on Analytical procedure development will be effective from June 2024. This guideline describes science and risk-based approaches to developing and maintaining analytical procedures suitable for assessing the quality of drug substances and drug products. This guideline complements ICH Q2 Validation of Analytical Procedures...

Swissmedic : Measures against nitrosamine impurities in medicinal products In summer 2018, drug regulatory authorities first became aware of nitrosamine impurities in various medicinal products. Since then, Swissmedic has evaluated and overseen measures to avoid impurities of this kind....