The Food and Drug Administration (FDA or Agency) is announcing the availability of a final guidance for industry entitled “Q9(R1) Quality Risk Management.”
The guidance was prepared under the auspices of the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH).
The guidance is a targeted revision of the 2006 guidance for industry “Q9 Quality Risk Management” and addresses product availability risks due to manufacturing quality issues, lack of understanding as to what constitutes formality 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 revision is intended to provide guidance on quality risk management principles and tools that can be applied to different aspects of pharmaceutical quality.
The guidance replaces the draft guidance “Q9(R1) Quality Risk Management” issued on June 15, 2022.
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 (medicinal) products, biological and biotechnological products (including the use of raw materials, solvents, excipients, packaging and labeling materials in drug (medicinal) products, biological and biotechnological products).