Module 3 - Strategic case studies in practice

ICH Q3D(R1) Guideline

found by experiment or observation, that causes no detectable adverse alteration of morphology, functional capacity, growth, development, or life span of the target organism under defined conditions of exposure .

NOEL: No-Observed-Effect Level: The highest dose of substance at which there are no biologically significant increases in frequency or severity of any effects in the exposed humans or animals. NTP: National Toxicology Program. (USA) OEHHA: Office of Environmental Health Hazard Assessment. (California, USA) OELV : Occupational Exposure Limit Value. OSHA: Occupational Safety and Health Administration. (USA) PEL: Permitted Exposure Limit. PDE: Permitted Daily Exposure: The maximum acceptable intake of elemental impurity in pharmaceutical products per day. Product Lifecycle: All phases in the life of the product from the initial development through marketing until the product’s discontinuation. (ICH Q9) Quality: The degree to which a set of inherent properties of a product, system, or process fulfills requirements (see ICH Q6A definition specifically for quality of drug substance and drug products). (ICH Q9) Quality Risk Management: A systematic process for the assessment, control, communication, and review of risks to the quality of the drug product across the product lifecycle. (ICH Q9) Quality System: The sum of all aspects of a system that implements quality policy and ensures that quality objectives are met. (ICH Q10) Risk: The combination of the probability of occurrence of harm and the severity of that harm. (ISO/IEC Guide 51, ICH Q9) Risk Acceptance: The decision to accept risk. (ISO Guide 73)

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