Module 3 Presentations

07/05/2024

ICH Q3D Guideline for Elemental Impurities – Practical Implementation of ICH Q3D

• ICH Q3D recommends taking a

risk-based

approach .

• Focus is on the final product: all potential sources of elemental impurities should be considered and evaluated for their contribution to the drug product. • The product assessment will form the basis of a specific control strategy and should be available to be presented to Regulators during an inspection upon request. • ICH Q3D advocates a 3-step process

 Identify  Evaluate  Summarize Control

https://www.ema.europa.eu/en/documents/presentation/presentation-elemental-impurity-risk-assessment-case-studies-andrew-teasdale-laura-rutter_en.pdf

Developing Specifications for the Active Ingredient

The Organisation for Professionals in Regulatory Affairs

19

What are N-nitrosamines?

Chemical compounds classified as probable human carcinogens on the basis of animal studies

Present in trace amounts in several products, common in water and foods e.g. cured meat products, processed fish, cocoa, beer).

• In pharmaceuticals Acceptable Intake (AI) limits are established for each N-nitrosamine based on a theoretical 1:100.000 excess lifetime cancer risk. • From a given AI, a specific limit that takes into account the maximum daily dose and treatment duration for a certain medicine is derived. A negligible risk is linked to levels of a certain nitrosamine under the established limit.

https://www.ema.europa.eu/en/documents/presentation/presentation-update-activities-linked-presence-n-nitrosamines-human-medicines-azevado-r ruepp-ema_en.pdf

Developing Specifications for the Active Ingredient

The Organisation for Professionals in Regulatory Affairs

20