EMA Clarifies Requirements for Peptones Used in Active Substance Manufacturing
The European Medicines Agency (EMA) on Monday clarified the documentation and declaration requirements for peptones used in the manufacture of active substances in an update to its quality of medicines questions and answers (Q&A) guide.The Q&A covers issues brought to EMA’s Joint Committee for Medicinal Products for Human Use/Committee for Medicinal Products for Veterinary Use Quality Working Party and express the harmonized position of European Economic Area competent authorities. Drugmakers with quality-related questions not addressed in the Q&A are instructed to contact EMA for more information.
Specifically, EMA answered two questions pertaining to peptone use during manufacturing, explaining how manufactures should document its use or notify regulators of any change related to the peptone being used.
In the first question, EMA says it is necessary to include the origin (animal or vegetable) and source of any peptone used in the fermentation process of an active substance in the active substance master file (ASMF), certificate of suitability (CEP) and marketing authorization dossiers.
If there is a change to the peptone used, EMA says active substance manufacturers should submit an appropriate variation to either the CEP or marketing authorization and communicate the change to any drugmakers that use the active substance in their products.
In the second question, EMA says that active substance manufacturers must declare if fish peptones have been used during manufacturing and ensure that histamines are kept to an acceptable level due to the risk of allergic reaction.
“If fish peptone is used in the fermentation process there is a potential serious risk to public health if it is contaminated with high levels of histamine. In order to reduce the risk to public health it is important that the finished product manufacturer is aware that fish peptone has been used in the manufacturing process and that histamine is also a specified impurity in the active substance which is controlled to an acceptable limit,” EMA writes.
EMA