Tag: ICH stability protocols

Case Study: Shelf Life Estimation for Low-Solubility Drug

Low-solubility active pharmaceutical ingredients (APIs) present complex formulation and stability challenges, often due to incomplete dissolution, erratic degradation kinetics, and formulation variability. In this case study, we walk through the practical application of ICH Q1E statistical principles to estimate shelf life for a poorly soluble drug, highlighting lessons learned and pitfalls avoided. 🔬 Drug Profile…

Shelf Life and Expiry, Shelf Life Prediction Models and Statistical Approaches

GMP Sign-Off Workflows for Stability Protocols

In the pharmaceutical industry, the stability protocol is the cornerstone of shelf-life determination and long-term product quality assurance. However, a well-designed protocol is only effective if it undergoes rigorous review and approval aligned with Good Manufacturing Practices (GMP). In this article, we explore the end-to-end GMP-compliant sign-off workflow for stability protocols, covering roles, responsibilities, documentation…

Good Manufacturing Practices (GMP) for Stability Studies, Pharmaceutical Quality and Practices