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Pharma Stability: Insights, Guidelines, and Expertise

Tag: electronic document management

Strategies for Handling and Storing Stability Data for Regulatory Submissions

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Strategies for Handling and Storing Stability Data for Regulatory Submissions Compliant Management of Stability Data for Global Regulatory Filing Introduction Stability Studies play a critical role in defining the shelf life, storage conditions, and packaging configuration of pharmaceutical products. The data generated from these studies forms a cornerstone of regulatory submissions worldwide, appearing in technical…

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Handling and Storing Stability Data for Regulatory Submissions, Stability Data and Report Management

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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  • Match Stability Study Container-Closure Systems to Final Market Packaging

    Understanding the Tip: Why container-closure systems matter: Stability testing simulates how a drug product will behave over its shelf life.
    If the container-closure system used… Read more

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