国内目前此类产品按照治疗用生物制品管理,尚无针对性的GMP,仅有若干技术指导原则,包括2003年CDE发布的《人基因治疗研究和制剂质量控制技术指导原则》、《人体细胞治疗研究和制剂质量控制技术指导原则》, 2016年CDE发布的《细胞治疗产品研究与评价技术指导原则(试行)》,国家卫生计生委与食品药品监管总局2015年发布的《干细...
3.12. All personnel should receive training on the principles of GMP that affect them and receive initial and periodic training relevant to their tasks. 简译: 所有人员应接受与之有关的GMP基本要求的培训,应当接受与其工作有关的上岗前培训和定期培训。 康利华观点: 1、对GMP条款和基本知识的了解、熟悉和...
2.12.It follows that, in laying down the GMP requirements applicable to ATMPs, it is necessary to recognise a certain level of flexibility so that the ATMP manufacturer can implement the measures that are most appropriate having regard to specific characteristics of the manufacturing process and of ...