摘要
依据目前的药品生产质量管理规范(GMP)的规定,药品生产厂家对使用的任何药物赋形剂的质量负责。与药物的活性成分不同,赋形剂没有普遍认可的生产标准予以规范。
Under current good manufacturing practice (GMP) regulations, the pharmaceutical manufacturer is responsible for the quality any excipients used, Unlike active ingredients, excipients do not have a universally accepted code defining the standards required in their manufacture.