NEW FDA GUIDANCE ON RISK MANAGEMENT RELEASED

Drug manufacturers that implement effective quality risk management systems could see fewer government regulators peering over their shoulders, suggests a new guidance on risk management released by the FDA.

Effective quality risk management can facilitate better and more informed decisions by manufacturers and provide regulators with greater assurance of a company's ability to deal with potential risks, according to the International Conference on Harmonisation (ICH) "Q9 Quality Risk Management" draft guidance, released by the FDA.

This, in turn, "can beneficially affect the extent and level of direct regulatory oversight," notes the ICH guidance, which supports the FDA's "Pharmaceutical Current Good Manufacturing Practices [cGMPs] for the 21st Century" initiative, which the agency finalized last fall.

The new ICH guidance provides principles and examples of tools for quality risk management that can be applied throughout the life cycle of the drug substance or product. "The guidance is intended to enable regulators and industry to make more effective and consistent risk-based decisions," the document states. The two primary principles of quality risk management are:

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

Risk management activities are usually, but not always, undertaken by interdisciplinary teams, the guidance says. Teams should include experts from the appropriate areas involved, and individuals who are knowledgeable of the quality risk management process, it adds. Steps to initiate a quality risk management process include:

Defining the problem and/or "risk question," including assumptions identifying the potential for risk; Assembling background information and data on the potential hazard, harm or human health impact relevant to the risk assessment; Defining how decisionmakers will use the information, assessment and conclusions;

Identifying a leader and necessary resources; and Specifying a timeline and deliverables for the risk management process.

The results are represented pictorially in the form of a tree of fault modes, the guidance says. "The method can be used to establish the pathway to the root cause of the failure," it says. "Fault Tree Analysis is a good method for evaluating how multiple factors affect a given issue," it adds.