Https://database.ich .org/sites/default/f Iles/Q9_Guideline.pd F.pdf

Q9_Guideline.pdf
Preview of https://database.ich .org/sites/default/f iles/Q9_Guideline.pd f
🔗 Source: database.ich.org
📊 Size: 204 KB
👤 Author: Frank Rockhold
⬇️ Downloads: 259

Summary

The ICH Harmonised Tripartite Guideline on Quality Risk Management (Q9) provides a systematic approach to quality risk management in the pharmaceutical industry. It defines quality risk management as a systematic process for the assessment, control, communication, and review of risks to the quality of medicinal products. The guideline outlines the principles of quality risk management, including a general quality risk management process, risk assessment, risk control, risk communication, and risk review. It also discusses the integration of quality risk management into industry and regulatory operations and provides definitions and references. The guideline includes annexes on risk management methods and tools, as well as potential applications for quality risk management. Its purpose is to offer a foundation for quality risk management, supporting other ICH Quality documents and complementing existing quality practices and guidelines.

Description

The ICH Harmonised Tripartite Guideline on Quality Risk Management (Q9) provides a systematic approach to quality risk management in the pharmaceutical...

Technical Information

  • File Format: PDF
  • File Size: 204 KB
  • Pages: 23
  • Language: EN
  • Author: Frank Rockhold
  • Total Downloads: 259
  • Last Updated: 3 weeks ago

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