EMA: Guidance on Sampling Excipients at High Risk of Glycol Contamination
In its Q&A section on GMP and GDP, EMA has added questions and answers on additional guidance to Annex 8 on sampling excipients at risk of glycol contamination, emphasising stringent measures for high-risk substances. In seven key questions, EMA highlights the risks of diethylene glycol (DEG) and ethylene glycol (EG) contamination, emphasising the responsibilities of manufacturers and supply chain management.
The EMA clarifies that sampling only part of the containers is generally not possible when brokers or intermediaries are involved in the supply chain, as the supply chain is too complex and long in these cases. Companies sourcing excipients with a high risk of DEG/EG contamination are urged to demonstrate a thorough knowledge of the supply chains and to implement robust quality risk management practices.
The EMA discusses the European Pharmacopoeia Commission (EPC) DEG/EG limit test, noting its limitations for a large number of containers due to its gas chromatographic method. Alternative tests are being investigated, but the current method remains the official standard for confirming compliance.
The EMA emphasises compliance with European Pharmacopoeia monographs to ensure adequate control of DEG/EG contamination risks. Compliance is verified during GMP inspections.
Source:
EMA: Guidance on good manufacturing practice and good distribution practice: Questions and answers
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