Module 3 - Strategic case studies in practice

ICH Q3D(R1) Guideline

G LOSSARY

ACGIH: American Conference of Governmental Industrial Hygienists.

ATSDR: Agency for Toxic Substances and Disease Registry.

CEC: Commission of the European Community. CFR: Code of Federal Regulations. (USA)

Change Management: A systematic approach to proposing, evaluating, approving, implementing and reviewing changes. (ICH Q10)

CICAD: Concise International Chemical Assessment Documents. (WHO)

Container Closure System: The sum of packaging components that together contain and protect the dosage form. This includes primary packaging components and secondary packaging components, if the latter are intended to provide additional protection to the drug product. A packaging system is equivalent to a container closure system. (ICH Q1A) Control Strategy: A planned set of controls, derived from current product and process understanding, that assures process performance and product quality. The controls can include parameters and attributes related to drug substance and drug product materials and components, facility and equipment operating conditions, in-process controls, finished product specifications, and the associated methods and frequency of monitoring and control. (ICH Q10) Control Threshold: A limit that is applied during the assessment of elemental impurities to determine if additional control elements may be required to ensure that the PDE is not exceeded in the drug product. The limit is defined as 30% of the PDE of the specific elemental impurity under consideration. Daily Dose: The total mass of drug product that is consumed by a patient on a daily basis.

EFSA: European Food Safety Agency.

EHC: Environmental Health Criteria. (IPCS, WHO)

EU SCOEL: European Scientific Committee on Occupational Exposure Limits.

EU SEG: European Union Scientific Expert Group.

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