A Frequently Overlooked Yet Crucial Step in Generic Drug Development. When a formulation is finalized and development stability data is already generated, teams often wonder: Q: “If we manufacture a fresh batch for the pivotal bioequivalence (BE) study, do we need to place it on stability again?” Answer: YES. Absolutely. Even if: The pivotal BE…
The Common Technical Document (CTD) is a critical component of regulatory submissions, and presenting precise stability data ensures compliance and accelerates approval timelines. Beyond the usual challenges, there are advanced areas that pharmaceutical companies should address to achieve excellence in their submissions. Key areas to focus on for a superior stability data submission Failure to…
Forced degradation studies are more than a regulatory checkbox—they are a cornerstone of quality assurance, designed to reveal the intrinsic stability of a molecule and its behavior under stress. Yet, their potential is often underutilized due to common yet avoidable pitfalls. Key Insights into Frequent Challenges Inadequate Stress Conditions The art of forced degradation lies…
Regulatory excellence lies in the details. Minor oversights in stability and analytical sections can trigger major delays or rejections. exploring three critical but often missed pitfalls: Missing Microbial Limits Justification in Stability for Non-Sterile Products Even non-sterile formulations must maintain acceptable microbial limits throughout shelf life. Failing to include microbial testing data during stability studies…
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