Case Studies in Stability Testing

Key Lessons from Regulatory Inspections on Stability Studies

Key Lessons from Regulatory Inspections on Stability Studies What Regulatory Inspections Reveal About Stability Testing in Pharma: Key Lessons and Best Practices Introduction Regulatory inspections play a vital role in evaluating the integrity, reliability, and compliance of pharmaceutical Stability Studies. Whether conducted by the FDA, EMA, WHO PQP, or national authorities, these inspections often uncover…

Case Studies in Stability Testing, Lessons from Regulatory Inspections on Stability Studies

Real-World Case Studies in Pharmaceutical Stability Testing

Real-World Case Studies in Pharmaceutical Stability Testing Lessons from the Field: Real-World Case Studies in Pharmaceutical Stability Testing Introduction Stability testing forms the backbone of pharmaceutical product development, regulatory approval, and ongoing quality assurance. While ICH guidelines and WHO frameworks provide robust structures for study design, real-world implementation often presents unforeseen challenges—ranging from formulation degradation…

Case Studies in Stability Testing

Successful Stability Study Strategies in Drug Development

Case Studies in Stability Testing, Successful Stability Study Strategies in Drug Development