Module 3 - Strategic case studies in practice

ICH Q3D(R1) Guideline

NOAEL: No-Observed-Adverse-Effect Level: Greatest concentration or amount of a substance, 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:

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