Is it necessary for the active substance specifications to declarethat fish peptone has been used in the manufacturing process and that histamineis a specified impurity controlled to an agreed limit?
活性物质标准是否需要明确在生产过程中使用了鱼蛋白胨，并且组胺是控制在协定范围内的特定杂质？
1 回答
Yes.If fish peptone is used in the fermentation process there is a potentialserious risk to public health if it is contaminated with high levels ofhistamine. In order to reduce the risk to public health it is important thatthe finished product manufacturer is aware that fish peptone has been used inthe manufacturing process and that histamine is also a specified impurity inthe active substance which is controlled to an acceptable limit.
是的。如果在发酵过程中使用鱼蛋白胨，如果鱼蛋白胨被高浓度的组胺污染，则对公众健康有潜在的严重风险。为了降低对公众健康的风险，成品制造商必须知道到在制造过程中使用了鱼蛋白胨,并且组胺也是活性物质的特定杂质之一，该杂质被控制在可接受的限度内。
