Dear Chromicent customers and friends,
With chapter <1221> Ongoing Procedure Performance Verification (OPPV), the USP provides long-awaited guidance on how analytical methods can be efficiently monitored and further developed after validation.
At the same time, the ICH Q1 Draft 2025 brings real innovations in stability strategies – from statistical innovations to life cycle-oriented models.
At Chromicent, we already apply these principles in practice every day.
Our expertise in Life Cycle Management (LCM), Quality by Design (QbD) and the practical implementation of USP <1220>, ICH Q2(R2) and ICH Q14 is recognised nationally and internationally. We are happy to support you with our know-how. You can find out what we can do for you in our latest newsletter.