ICH Q9(R1) Quality Risk Management Guidance Document Available

FDA announced the publication of a final guidance for industry, Q9(R1) Quality Risk Management, which was prepared with the support of the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH).

This guidance is a targeted revision of the 2006 guidance for industry Q9 Quality Risk Management, which addresses product availability risks due to manufacturing quality issues, lack of understanding as to what is defined in quality risk management (QRM) work, lack of clarity on risk-based decision-making, and high levels of subjectivity in risk assessments and QRM outputs. The recent revision is intended to provide guidance on QRM principles and tools that can be used for different aspects of pharmaceutical quality.

Additionally, the guidance replaces the draft guidance Q9 (R1) Quality Risk Management that was issued on June 15, 2022.

Source: FDA