CGMP documentation was discarded without being assessed by your quality unit.
CGMP文件记录没有经过质量部门评估就被丢弃了。
A very similar section on equipment cleaning (211.67) was included in the 1978 CGMP regulations.
在1978 CGMP法规中也包含了非常相似的有关设备清洗的章节(211.67)。
AIM: To study the effect of cGMP-dependent protein kinase (PKG) on the pathogenesis of burn shock.
目的:探讨蛋白激酶g (PKG)在烧伤休克发病机制中的作用。
You will also hear latest updates on various GMP and cGMP from internationally recognised regulatory experts.
您可以听到来自国际认可的法规专家带来的各国GMP的最新更新和消息。
In general, the hardware of a computer system is considered to be equipment within the meaning of the CGMP regulations.
通常,计算机系统的硬件被认为是符合CGMP规范的内涵的设备。
No. Neither the CGMP regulations nor FDA policy specifies a minimum number of batches to validate a manufacturing process.
不需要,不论cGMP法规还是FDA的政策都没有指定进行工艺验证的最少批次。
Therefore, the inhibition effect of Longyachongmu on specific immunity might be related to cAMP and cGMP contents in Lymphocyte.
由此推测,龙牙葱木总甙对特异性免疫功能的抑制作用可能与淋巴细胞内环核苷酸含量变化有关。
To ensure full compliance with the CGMP regulations, themanufacturer also should maintain adequate documentation of the correctiveaction.
为保证全面符合CGMP沙堆,生产商还应维护充分的纠正措施的文件记录。
In the proposed rule, FDA requested comments on current good manufacturing practice (CGMP) requirements applicable to combination products.
在法规提案中,FDA征求关于现行结合产品生产管理规范(CGMP)要求的意见。
Indicate whether individuals responsible for data integrity lapses remain able to influence CGMP-related or drug application data at your firm.
说明是否对数据完整性问题承担责任的个人仍有能力对你公司对CGMP相关或药物应用数据产生影响。
Tidy up and manage the technical drawings, manual, documents, maintenance record and keeping the updated drawings to comply with cGMP requirement.
负责工厂的建筑物和公用设施的技术图纸、手册、文件、运行维修记录,确保公用系统图纸的及时更新,使其符合GMP要求。
AIM: to study the effect of xin-tong capsule on nitric oxide production and cGMP content of ventricular myocardium in rats with experimental myocardial ischemia.
目的:探讨心通胶囊对实验性大鼠心肌缺血的预防效果及其与一氧化氮形成的相关机制。
Objective:To ascertain whether CO/cGMP pathway is invovled in the protective mechanism of Endogenous carbon monoxide in the rat liver undergone ischemic preconditioning.
目的:研究内源性一氧化碳(CO)在大鼠肝脏缺血预处理中的保护作用机制。
2014-2015, engaged in research, development and validation of automatic burdening and material management system for CGMP oral preparation in Cisen Pharmaceutical Co. , Ltd.
2015年进行辰欣药业CGMP口服制剂自动配料及物料管理系统的研发、验证工作。