Different Regulatory Approaches to Excipient Requirements: The Case of EG/DEG Contamination Risk in Pharmaceuticals

Dr. Miquel Mir, Pharma Regulatory Mgr, just published the article “Different Regulatory Approaches to Excipient Requirements: The Case of EG/DEG Contamination Risk in Pharmaceuticals“ in the International Journal Pharmaceutical Excipients (IJPE) reviewing the current regulatory approaches adopted by the U.S. FDA, the EMA, the World Health Organization (WHO) and major Pharmacopoeias (USP and Ph. Eur.) with respect to EG/DEG contamination risk for excipients. 

Particular attention is given to differences in the definition of “high risk” excipients, the setting of EG/DEG limits as identity or as impurity tests, and the different considerations for excipients in which EG/DEG may occur as process related by-products, such as ethoxylated excipients. This review highlights the critical role of supply chain integrity, traceability, and supplier qualification in preventing EG/DEG adulteration events. Furthermore, it identifies opportunities for risk based, harmonised regulatory strategies that would enhance patient safety while avoiding unnecessary and inefficient testing burdens across global pharmaceutical supply chains.

As per the main conclusions of the article, we can confirm that Croda Pharma is particularly well positioned to minimise the risk of EG/DEG contamination within its excipient portfolio. This is supported by the company’s robust GMP-based quality systems, including EXCiPACT certification and a direct-to-customer supply model through local sales offices and distribution channels. Together, these measures help ensure full traceability, maintain supply chain integrity, and significantly reduce the risk of product adulteration throughout the distribution process.

You can read the article here.