Post by Solvias

FDA Complete Response Letters offer rare visibility into where drug applications fall short. After exploring extractables & leachables (E&L)–related deficiencies in our first CRL-focused white paper, we now turn to another critical area of regulatory scrutiny: container closure integrity testing (CCIT). In this second paper in our CRL insights series, we analyze CCIT-related observations from recent FDA CRLs and translate them into clear, actionable lessons for drug developers—highlighting common pitfalls and what regulators expect to see in a defensible CCIT strategy. 📄 Download the CCIT white paper: https://lnkd.in/eY5yrpjJ 📄 Download the E&L white paper: https://lnkd.in/ezKu_JXE #CCIT #FDA #CMC #DrugDevelopment