Perspective on Quality Risk Management of Pharmaceutical Quality
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Perspective on Quality Risk Management of Pharmaceutical Quality H. Gregg Claycamp Drug Information Journal 2007 41: 353 DOI: 10.1177/009286150704100309 The online version of this article can be found at: http://dij.sagepub.com/content/41/3/353
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Perspective on Quality Risk Management of Pharmaceutical Quality
H. Gregg Claycamp, PhD Food and Drug Administration, Center for Veterinary Medicine. office of New Animal Drug Evaluation Rockville, Maryland
Key Words Quality risk management; Risk assessment: Uncertainty: FMEA; CGMP: Variability Correspondence Address H. Gregg Claycamp, Food
and Drug Administration, HFD-300. CDER Office of Compliance. 11919 Rockville Pike, Rockville. MD 20852 (e-mail: [email protected] .go+
Quality risk management for the pharmaceutical industry was recently defined in internationally harmonized guidance as a systematic processfor the assessment, contrd, communication, and review of risks to the quality of the drug product a m s the product life qcle. Two overarchingprinciples for quality risk management are that evaluations of risk should be scientificallybased and ultimately linked to risk to the patient, and the level of effortand documentation of quality risk management processes should be commensurate with the level of risk. Numerous t d s f o r risk management comefrom other applied sciences and manufacturing hav-
IN T R O D UC T I 0 N This essay discusses general principles and several tools for risk management as background to industry and regulator efforts to implement concepts of risk management for pharmaceutical quality. The essay presents some features of low- and high-level tools for risk management that might be applied as quality risk management becomes common practice in pharmaceutical manufacturing and regulation. The shared industry and regulatory development of quality risk management theory and applications for controlling the risk to pharmaceutical quality, ultimately linking back to risks to the patient, continues to foster discussion, debate, and innovation.
RISK MANAGEMENT In general, risk management is a systematic application of policies, procedures, and practices to identifying,assessing, analyzing, treating, monitoring, and communicating risks to life, property, or other valuables. Risk managers use objective information from analytical tools, including risk assessment, benefit-cost analysis, trade-off analysis, or quantitative decision analysis, along with the subjec
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