Ethylene glycol (EG) and diethylene glycol (DEG) contamination has been discovered in several medicinal products in African and Asian countries over the last 2 years (see WHO alerts). For example, confirmed cases of propylene glycol adulterated with EG led to over 190 fatalities in Indonesia.1 In response, both the US Pharmacopeia (USP) and the European Pharmacopoeia (Ph. Eur.) have taken action to address this public health risk.
This webinar covers:
- the framework, approaches and requirements of both pharmacopoeias on controlling EG/DEG in excipient monographs;
- current individual and joint actions being taken by each pharmacopoeia;
- the background to the regional differences between the pharmacopoeias;
- the importance of stakeholder input and opportunities for interaction.
1. Elanda Fikri, Yura Witsqa Firmansyah. A Case Report of Contamination and Toxicity of Ethylene Glycol and Diethylene Glycol on Drugs in Indonesia. Environment and Ecology Research, 2023, vol. 11, nº 2, p. 378-384. DOI : 10.13189/eer.2023.110211.
Target audience
Professionals working in quality control/compliance, manufacturing and regulatory affairs, as well as in national regulatory agencies and inspection authorities.
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