FDA Guidance Q9 on Quality Risk Management

• By: Staff Editor
• Date: November 22, 2016
• Source: http://www.fda.gov/

FDA Guidance Q9 on Quality Risk Management

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 recent years, the importance of quality systems has been recognized in the pharmaceutical industry, and it is becoming evident that quality risk management is a valuable component of an effective quality system.

This guidance document offers a systematic approach to quality risk management. Specifically, it provides guidance on the principles and some of the tools of quality risk management that can be applied to different aspects of pharmaceutical quality including development, manufacturing, distribution, inspection, and submission/review processes throughout the lifecycle of drug substances, drug products, biological and biotechnological products.

Quality Risk Management Principles

The key principles of quality risk management are:

• The evaluation of the risk to quality should be based on scientific knowledge and ultimately link to the protection of the patient.
• The level of effort, formality, and documentation of the quality risk management process should be commensurate with the level of risk.

Risk Management Tools

Here is the list of some of the risk management tools:

• Basic risk management facilitation methods (flowcharts, check sheets, etc.)
• Failure Mode Effects Analysis (FMEA)
• Failure Mode, Effects, and Criticality Analysis (FMECA)
• Fault Tree Analysis (FTA)
• Hazard Analysis and Critical Control Points (HACCP)
• Hazard Operability Analysis (HAZOP)
• Preliminary Hazard Analysis (PHA)
• Risk ranking and filtering
• Supporting statistical tools

Related Training:

Quality Risk Management Overview for Pharma and Biopharma, ICH Q9/ISO 14971