关于Q7a的疑问

beiwei5du

This guidance excludes all vaccines, whole cells, whole blood and plasma, blood and plasma derivatives (plasma fractionation), and gene therapy APIs. However, it does include APIs that are produced using blood or plasma as raw materials. Note that cell substrates (mammalian, plant, insect or microbial cells, tissue or animal sources including transgenic animals) and early process steps may be subject to GMP but are not covered by this guidance. In addition, the guidance does not apply to medical gases, bulk-packaged drug (medicinal) products (e.g., tablets or capsules in bulk containers), or radiopharmaceuticals.本指南不包括所有疫苗、完整细胞、全血和血浆、全血和血浆的衍生物（血浆成分）和基因治疗的原料药。但是却包括以血或血浆为原材料生产的原料药。值得注意的是细胞培养基（哺乳动物、植物、昆虫或微生物的细胞、组织或动物源包括转基因动物）和前期生产可能应遵循GMP规范，但不包括在本指南之内。另外，本指南不适用于医用气体、散装的制剂药（例如，散装的片剂和胶囊）和放射性药物的生产。

"This guidance excludes all vaccines, whole cells, whole blood and plasma, blood and plasma derivatives (plasma fractionation), and gene therapy APIs. However, it does include APIs that are produced using blood or plasma as raw materials.
"这句话如何理解？？指南不包全血和血浆衍生物（血浆成分），但是后面又说包括以血或血浆为原材料生产的原料药？？？

大呆子

请那些经常引用Q1－Q11的专家来回答一下

bolibei

‘Q7，1序言，1.3应用范围“ 已经说的明白，本指南不适用于无菌API。（原话是说：本指南适用于成为无菌API前的步骤，血和血浆产品妥妥的无菌吧？）

beiwei5du

bolibei 发表于 2015-4-27 08:34
‘Q7，1序言，1.3应用范围“ 已经说的明白，本指南不适用于无菌API。（原话是说：本指南适用于成为无菌API前 ...

这个我觉得你说得对，Q7A是不适合aseptic processing（无菌操作）的无菌原料药的，所以我明白了！谢谢！