ICH Q9(R1): Quality Risk Management (QRM) – Approaches and Practical Case Studies

¥62 ,500

This publication provides a comprehensive overview of the ICH Q9(R1) guidelines on Quality Risk Management (QRM), detailing the background, objectives, and key revisions. It explores the implications of these guidelines on formulation development, offers training material summaries, and discusses the interplay of knowledge management and subjectivity within QRM. Additionally, it presents case studies from various enterprises and examines the integration of knowledge management into business models and pharmaceutical quality systems.

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Description

This is a request, not an immediate purchase. Delivery takes about one week. Your card is authorized but not charged until the English PDF is ready.

Product ID: 1184

Publisher: Science & Technology

Publication Date: 2026-04-28

English Summary

This publication provides a comprehensive overview of the ICH Q9(R1) guidelines on Quality Risk Management (QRM), detailing the background, objectives, and key revisions. It explores the implications of these guidelines on formulation development, offers training material summaries, and discusses the interplay of knowledge management and subjectivity within QRM. Additionally, it presents case studies from various enterprises and examines the integration of knowledge management into business models and pharmaceutical quality systems.

Contents / Coverage

  • Chapter 1: Background, Objectives, and Key Points of the Revision of ICH Q9(R1) Quality Risk Management Guidelines
  • Chapter 2: How Formulation Development Changes with the Revision of ICH Q9(R1) Quality Risk Management Guidelines
  • Chapter 3: Summary of Training Materials Related to ICH Q9(R1) Quality Risk Management
  • Chapter 4: The Relationship Between Knowledge Management and Subjectivity in ICH Q9(R1) Quality Risk Management
  • Chapter 5: Case Studies Based on ICH Q9(R1) Quality Risk Management
  • Chapter 6: Knowledge Management and Quality Risk Management Case Studies in Enterprises Based on ICH Q9(R1)
  • Chapter 7: Knowledge Management Required by ICH Q9(R1) (Incorporating Individual Tacit Knowledge into the Organization) and Business Models
  • Chapter 8: Pharmaceutical Quality Systems, Quality Culture, and Knowledge Management in Relation to ICH Q9(R1)
  • Chapter 9: Risk-Based Compliance Inspections and Audits from the Perspective of Authorities

Why This May Matter Internationally

The ICH Q9(R1) guidelines are crucial for global pharmaceutical and biotechnology industries, as they establish a framework for managing quality risks in drug development and manufacturing processes. This publication is relevant for professionals involved in quality assurance, regulatory compliance, and risk management across international markets.

Keywords: Quality Risk Management,ICH Q9(R1),pharmaceuticals,knowledge management,case studies

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