The ICH Q9(R1) Guideline on Quality Risk Management has reached Step 4 of the ICH Process on 18 January 2023. 

Step 4: Adoption of an ICH Harmonised Guideline

Step 4 is reached when the Assembly agrees that there is sufficient consensus on the draft Guideline.

The Step 4 Final Document is adopted by the ICH Regulatory Members of the ICH Assembly as an ICH Harmonised Guideline at Step 4 of the ICH process.

This Guideline is intended to provide guidance on the 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 (medicinal) products, biological and biotechnological products (including the use of raw materials, solvents, excipients, packaging and labelling materials in drug (medicinal) products, biological and biotechnological products).