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Pharma Stability: Insights, Guidelines, and Expertise

Tag: QA stability documentation

Key Lessons from Regulatory Inspections on Stability Studies

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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…

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

Step-by-Step Guide to Stability Studies for Beginners in the Pharmaceutical Industry

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Step-by-Step Guide to Stability Studies for Beginners in the Pharmaceutical Industry

Educational Resources, Step-by-Step Guide to Stability Studies for Beginners

Quick Guide

  • Stability Tutorials
  • Stability Testing Types
    • Types of Stability Studies
    • Real-Time and Accelerated Stability Studies
    • Intermediate and Long-Term Stability Testing
    • Freeze-Thaw and Thermal Cycling Studies
    • Photostability and Oxidative Stability Studies
    • Stability Testing for Biopharmaceuticals
  • Stability Studies SOP
  • ‘How to’ – Stability Studies
  • Regulatory Guidelines
  • Shelf Life and Expiry Dating
  • Stability Documentation
  • Stability Studies – API
  • Stability Studies Blog
  • Stability Studies FAQ
  • Packaging – Containers – Closers
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  • Start Stability Protocol Design with ICH Q1A(R2) Guidance

    Tip: Always refer to ICH Q1A(R2) before designing a stability protocol to align with global regulatory expectations.
    Understanding the Tip: Why protocol design matters: Stability protocols define how long a pharmaceutical product remains safe and effective… Read more

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