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Current Good Manufacturing Practice regulations for Type A

机译:当前针对A类的良好生产规范

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摘要

As with medicated feeds, "current good manufacturing practice" regulations exist for Type A medicated article/drug premixes. Since premix manufacturers and basic drug manufacturers are already quite familiar with the CGMP regulations for Type A medicated articles, this article is directed at the newer drug premixer and the feed manufacturer who may be considering production of Type A medicated articles. Where appropriate, comparisons are made with the feed CGMP regulations discussed in the precedingarticle. Type A medicated articles are drug premixes of specific potency whose primary function is to serve as a drug source for producing medicated feeds — i.e., Type B and C medicated feeds. High potency Type A articles can also be used to produce lower potency Type Aproducts. As drug premixes, however, all Type A products are concentrated sources of drugs. With some technical exceptions, an approved New Animal Drug Application (NADA), or form FD-356, is required to produce a Type A product.
机译:与含药饲料一样,A类含药制品/药品预混合物也有“现行的良好生产规范”规定。由于预混料生产商和基础药物生产商已经非常熟悉A型药物制品的CGMP法规,因此本文针对的是可能正在考虑生产A型药物制品的新型药物预混合器和饲料生产商。在适当的情况下,可与前文讨论的饲料CGMP法规进行比较。 A类药物制品是具有特定效力的药物预混合物,其主要功能是用作生产药物饲料(即B和C类药物饲料)的药物来源。高效力的A型物品也可用于生产低效力的A型产品。但是,作为药物预混合物,所有A类产品都是药物的集中来源。除某些技术例外,生产A型产品需要批准的新动物药品申请(NADA)或表格FD-356。

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