原文由 poorlittle(poorlittle) 发表:
原文由 天晴了(smileqing) 发表:
1.2 Regulatory Applicability 1.2法规的适用性
Within the world community, materials may vary as to their legal classification as an API. When a material is classified as an API in the region or country in which it is manufactured or used in a drug product, it should be manufactured according to this guidance.
在世界范围内对原料药的法定分类是各不相同的。当某物料在某个地区或国家被划分为原料药用于制剂的生产或使用时,就应该按照本指南进行生产。
“当某物料在某个地区或国家被划分为原料药用于制剂的生产或使用时” 好像是指“当某物料在某个地区或国家被划分为原料药, 而此原料药用于制剂的生产或使用时” 。
但我觉得原文的意思好像是“若某物料在某个地区或国家被划分为原料药, 当生产该物料或将该物料用于制剂时”
换句话说, ( Manufacture该物料) or ( use 该物料in producing drug ) 时, according to this guidance
1.2 Regulatory Applicability 1.2法规的适用性Within the world community, materials may vary as to their legal classification as an API. When a material is classified as an API in the region or country in which it is manufactured or used in a drug product, it should be manufactured according to this guidance.在世界范围内对原料药的法定分类是各不相同的。若某物料在某个地区或国家被划分为原料药, 当生产该物料或将该物料用于制剂时,就应该按照本指南进行生产。1.3 Scope 1.3范围
This guidance applies to the manufacture of APIs for use in human drug (medicinal) products. It applies to the manufacture of sterile APIs only up to the point immediately prior to the APIs being rendered sterile. The sterilization and aseptic processing of sterile APIs are not covered by this guidance, but should be performed in accordance with GMP guidances for drug (medicinal) products as defined by local authorities.
本指南适用于人用药品所用原料药的生产。它适用于无菌原料药在灭菌前的步骤。本指南不包括无菌原料药的消毒和灭菌工艺,但是,应当符合地方当局所规定的药品生产的GMP指南。
此处关于Drug (Medicinal) Product的翻译有些疑问。在本指南中术语定义中指出 Drug (Medicinal) Product意思为The dosage form in the final immediate packaging intended for marketing. (Reference Q1A)。因此把Drug (Medicinal) Product合并译为药品或者制剂。不知是否可行