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ICH - Q9(R1) Quality Risk Management Draft Guidance Uupdation

The International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) It is commonly understood that Risk is defined as the combination of the probability of occurrence of harm and the severity of that harm.


Risk Management principles are effectively utilized in many areas of business and government including finance, insurance, occupational safety, public health, pharmacovigilance, and by agencies regulating these industries.

In the pharmaceutical sector, the principles and framework of ICH Q9, coupled with the official ICH training material that supports this guideline, are instrumental in enhancing the application of effective quality risk management by industry and regulators.


The purpose of this document is to offer a systematic approach to quality risk management for better, more informed, and timely decisions.


  1. It serves as a foundation or resource document that is independent of, yet supports, other ICH Quality documents and complements existing quality practices, requirements, standards, and guidelines within the pharmaceutical industry and regulatory environment.

  2. It specifically provides guidance on the principles and some of the tools of quality risk management that can enable more effective and consistent risk-based decisions, both by regulators and industry, regarding the quality of drug substances and drug (medicinal) products across the product lifecycle.

  3. It is not intended to create any new expectations beyond the current regulatory requirements.

This guideline provides principles and examples of tools for quality risk management that can be applied to different aspects of pharmaceutical quality.


These aspects include development, manufacturing, distribution, and the inspection and submission/review processes throughout the lifecycle of drug substances, drug products, biological and biotechnological products (including the use of raw materials, solvents, excipients, packaging and labeling materials in drug products, biological and biotechnological products).

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