WORKSHOP ON IMPURITIES AND DEGRADATION PRODUCTS

The impurity workshop was held by RD&C and ICIQ at the ICIQ Institut Català d’investigació Química in Tarragona/ Spain on May 5th 2015. It was a problem orientated workshop giving a detailed insight in the control of pharmaceutical impurities and degradation products in drug substance and drug products.

The agenda involved a comprehensive overview on regulatory aspects, practical tipps and tricks for the identification, isolation and characterisation of impurities as well as sessions dedicated on current hot topics of genotoxicity and elemental impurities. Approaches for in silico toxicity analysis and statistical tools for impurity evaluation are also covered.

TALKS AND TOPICS COVERED

Overview: terminology; impurity classes; regulatory aspects in drug substance and drug product

Dr. Helmut Buschmann, RD&C

Impurities in excipients

Dr. Helmut Buschmann, RD&C

Polymorphs as impurities: analysis and regulatory aspects

Dr. Jordi Cerón, CRYSFORMA/ ICIQ

http://www.crysforma.com/

Statistical evaluation of stability data according to the ICH Q1E guideline – Shelf-life and Out of Specification data

Dr. Andrea Wolkerstorfer, RD&C

Genotoxic impurities: regulatory background and risk assessment from a regulatory perspective

Dr. Norbert Handler, RD&C

In Silico tools and methods for toxicological assessment of impurities

Dr. Andrea Wolkerstorfer, RD&C

Elemental impurities according to the guideline

Dr. Norbert Handler, RD&C

Control of impurities: The Quality by Design approach

Dr. Fernando Bravo CSOL/ ICIQ

http://www.catalytic-solutions.com/

Please contact RD&C if you are interested in the documentation of the workshop!

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