Risk Management: A New FDA Guidance
Written by: Maria Duguine
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 importance of quality systems has been recognized in the pharmaceutical industry and it is evident that quality risk management is a valuable component of an effective quality system.
This Q9(R1) Quality Risk Management guideline provides principles and examples of tools for quality risk management that can be applied to different aspects of pharmaceutical quality. However, this is an ICH guidance which was published by ICH in January and accepted by FDA in May. It is the second edition, the first was published by ICH and accepted by FDA in 2005. The document was published with the assistance of ISO Technical Committee 210 Joint Working Group 1, the creators of ISO 14971, medical device standard which was first published in 2000 and has been revised twice. A number of definitions that appear in Q9 originated in 14971, so that is why they are referenced to ISO Guide 51. Those referenced to ISO Guide 73 are from ISO 31000, a business risk and not a safety risk standard.
In my point of view, the most important are the examples that are mentioned in the guide in areas with little follow-up in companies, such as: Training and Education and Periodic Review. In general, these areas are only developed when there is an upcoming audit, and this must be done in the companies in a natural and proactive way. Having it implemented in the quality system, and complying with it, results in simpler, faster and less expensive audits.
Find a copy of the guide at this link: https://www.fda.gov/regulatory-information/search-fda-guidance-documents/q9r1-quality-risk-management
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