EMA: 3 new Q&As on Diethylene Glycol (DEG) and Ethylene Glycol (EG)
EMA has added three new questions to its guidance on good manufacturing practices to address risks of diethylene and ethylene glycol (DEG/EG) contamination in glycerol and other excipients.
The agency advises treating glycerol, propylene glycol, and certain macrogols as high-risk materials, requiring thorough supplier oversight and testing according to the Ph. Eur. monograph.
EMA acknowledges challenges in conducting the recommended gas chromatographic test for DEG/EG on large container batches but maintains it as the official method while exploring alternatives.
The guidance also outlines expectations for marketing authorisation applicants to include adequate excipient specifications and risk mitigation strategies in their control strategies.
Source:
EMA: Guidance on good manufacturing practice and good distribution practice: Questions and answers - EU GMP guide annexes: Supplementary requirements: Annex 8
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