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Home » FDA Guidance Provides Basic 'Risk Assessment 101' Overview
FDA Guidance Provides Basic 'Risk Assessment 101' Overview
June 6, 2006
The FDA just issued an International Conference on Harmonisation (ICH) guidance intended to enable pharmaceutical regulators and industry to make more effective and consistent risk-based decisions. The guidance provides mostly basic, overview information that is probably most useful to those in industry with less experience in the area, such as a biotech start-up or smaller medical device firm.
The guidance was issued by the agency's Center for Drug Evaluation and Research and its Center for Biologics Evaluation and Research.
"This will most help those who don't quite know how to get started" on a risk assessment program, Ofni Systems President Ty Mew told PIR June 3. "It's Risk Assessment 101," he said. Another bonus: The guidance may help protect companies from "over selling" consultants who insist companies need more bells and whistles than the FDA requires, Mew added.
Some FDA-regulated life science companies have struggled with the concepts behind risk assessment and management since the agency relaxed its Part 11 requirements in 2003.
While some companies have taken the initiative to develop their own risk methodologies based on workflow and other proprietary issues, other companies have been hesitant to do so until they were more confident of what the FDA expects, consultants have told PIR.
Standards and Tools Outlined
The FDA's new guidance Q9 Quality Risk Management, published in the June 2 Federal Register, provides risk-management standards and tools that can be used to maintain the different aspects of pharmaceutical quality including the development, manufacturing, distribution, inspection and submission/review processes throughout the life cycle of drug substances, drug products and biological and biotech products.
"Effective quality risk management can facilitate better and more informed decisions, can provide regulators with greater assurance of a company's ability to deal with potential risks and can beneficially affect the extent and level of direct regulatory oversight," the guidance states.
A quality risk-management system should provide "documented, transparent and reproducible methods," the guidance states.
The guidance recommends that a company forming a quality risk-management process:
Form a decisionmaking team of experts from the appropriate areas such as drug development or sales, as well as individuals knowledgeable about the quality risk management process; Identify what might go wrong, the probability it will go wrong and the consequences; Make decisions on how to accept risks or reduce them to an acceptable level. The amount of effort used for risk control should be proportional to the significance of the risk; Share information about risks and risk management with relevant parties; and Make risk management an ongoing part of the quality management process and implement a means to review or monitor events. The frequency of any review should be based on the level of risk and may involve reconsidering decisions about risk control.
Mostly Predictable
While the tone and content of the guidance is solid and predictable, it didn't contain greater mention of corrective and preventative action programs (CAPAs) and their role in risk management, Mew said.
"The FDA has been screaming 'CAPA, CAPA, CAPA' for five years now, so I was a little surprised not to see that mentioned" more in the guidance, he said.
The guidance's risk management methodology section, which includes a list of some tools such as failure mode effects analysis (FMEA), fault tree analysis (FTA) and hazard analysis and critical control points (HACCP), does tie risk assessment more to preventing or understanding the scope of failures, Mew pointed out.
To view the complete guidance, go to http://www.fda.gov/cder/guidance/7153fnl.pdf (http://www.fda.gov/cder/guidance/7153fnl.pdf). -- Dar Haddix (mailto:dhaddix@fdanews.com), Michael Causey
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