Module 3 - Strategic case studies in practice

List of abbreviations AI

Acceptable intake. In the context of this document, an intake level /limit associated with a theoretical excess lifetime cancer risk of 1:100,000 based on considerations in ICH M7(R1) for substances from the “cohort of concern”

API

Active Pharmaceutical Ingredient

AIM

Active Ingredient Manufacturer = active substance manufacturer

ALARA

as low as reasonably achievable

ALARP

as low as reasonably possible

BCNU

Bischloroethyl nitrosourea

CCNU

1-(2-Chloroethyl)-3-cyclohexyl-1-nitrosourea

CHMP

Committee for Human Medicinal Products

CPDB

Carcinogenic potency database

CoA

Certificate of Analysis

CoC

Cohort of Concern Compounds

CEP

Certificate of Suitability to the monographs of the European Pharmacopoeia (CEP)

CRS

Chemical Reference Substance (official standard)

DIPNA

N,N-diisopropylethyl-N-ethylamine

DMF

Dimethylformamide

DI

Direct injection

DS

Drug substance

EDQM

European Directorate for the Quality of Medicines

EFSA

European Food Safety Agency

EIPNA

Ethylisopropyl-N-nitrosoamine

EMA

European Medicines Agency

ENOCs

Endogenously produced N-nitroso compounds

EPA

Environmental Protection Agency

FDA

Food and Drug Administration

IARC

International Agency for Research on Cancer

IPC

In-process control

IR

Infrared Spectrometry

IU

International Units

LCDB

Lhasa Carcinogenicity Data Base

LOD

Limit of Detection

LTL

Less than Lifetime

EMA/369136/2020

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