The WHO provides GMP guidelines and also offers a program of GMP compliance certification. One of the most valuable document is the WHO Technical Report 908, which is available at http://whqlibdoc.who.int/trs/WHO_TRS_908.pdf#page=46 . In addition, the WHO offers many very useful GMP ...
7.25. The address and telephone number of themain contact for information on the product, clinical trial and for emergencyunblinding need not appear on the label where the subject has been given aleaflet or card which provides these details and who has been instructed tokeep this in their posse...
componentsorsubsystemsofGMP,whicharejointresponsibilitiesoftop managementandofproductionandqualitycontrolmanagement.Theseinclude hygiene,validation,self-inspection,personnel,premises,equipment,materials anddocumentation. “Goodpracticesinproductionandqualitycontrol”,providesguidance ...
7.25. The address and telephone number of themain contact for information on the product, clinical trial and for emergencyunblinding need not appear on the label where the subject has been given aleaflet or card which provides these details and who has been instructed tokeep this in their posse...
2、要求质量体系应包含GxP,不单单是GMP。 3、应保留技术转移过程中质量风险管理的程序和记录。 4、提出技术转移过程中的数据完整性要求,数据应符合ALCOA+原则。 5、对技术转移文件的,应包括下列内容: 标题 目的 范围 转移方和接收方的名称和地址 关键人员的名字及其职责 项目的阶段和活动 对厂房、设备、仪器、...
11 月 5 日,世界卫生组织(WHO)发布了“试验用药品GMP” 指南(Good manufacturing practices for investigational products)的征求意见稿。 该文件是对WHO GMP附录7的修订,目前正处于收集意见期,截止日期为2021年1月。此后,将于2021年2-3月份提交专家工作组,进行讨论,完善后进行第2轮意见收集。最终修订稿计划于2021...
由于旧版本发布日期较早,最近对COVID-19疗法进行检查时有了新的指南需求,WHO预认证小组—检查服务(PQTINS)提出了修订WHO人用临床试验用药品GMP的紧迫性。ECSPP第55次会议同意了该建议。 1.2.The objective of this update is tobring the guideline in line with current expectations and trends in goodmanufactu...
_中英文_附录2 WHO药品GMP指南
制药用水GMP(Good manufacturing practices: water for pharmaceutical use) 数据完整性指南(Guideline on data integrity); 世卫组织关于国际贸易中药品质量的认证计划(WHO Certification Scheme on the quality of pharmaceutical products moving in international commerce); ...
附录2 WHO药品GMP指南_中英文_.pdf,Annex 2 WHO good manufacturing practices for pharmaceutical products: main principles 附录2 WHO药品GMP:主要原则 Introduction引言 General considerations总则 Glossary术语 Quality management in the medicines industry: philo