In module 1 the 10 GMP-Golden rules are explained.
模块1对GMP的10项黄金原则进行了解释。
Participate in equipment remediation for GMP compliance.
参与对设备实施的各种合规型改造。
Sterile devices are never exempted from GMP requirements.
消毒器械从不受GMP要求豁免。
Do you establish a well-organized GMP documentation system?
您是否建立了清晰明确的药品GMP文件体系？
Be responsible for quality deviation and GMP corrective action.
负责质量偏差和GMP纠正行动。
To realize the goal of GMP is a broader and greater engineering.
实现GMP达标是一项涉及面较大的工程。
Companies organize production strictly according to GMP requirements.
公司严格按照GMP要求组织生产。
Participate in internal GMP inspection for all manufacturing functions.
参与所有生产操作的GMP内审。
Manufacturers should be aware of the GMP exemption status of their devices.
制造商应知晓其产品的GMP豁免状态。
GMP - 140 of platelet surface is a specifical index of platelet activation.
血小板表面gmp- 140是反映血小板活化的特异性指标。
Process validation is a key in execution of GMP in pharmaceutical enterprise.
工艺验证是制药企业实施GMP规范的关键问题。
Huakai Animal Health's products strictly comply with international GMP standards.
华凯动物保健有限公司的产品严格遵循国际GMP标准。
Test the platelet GMP -140 on the Flow Cytometer after 2 hours and within 24 hours.
待2小时后、24小时内在流式细胞仪上检测血小板GMP一140水平。
All numbering within this section coincides with actual numbering in the GMP Provision.
本节中的所有编号与GMP规定的实际编号一致。
Do you perform cleaning validation properly according to GMP Guidelines (revised in 2010)?
您按照药品GMP(2010年修订)的要求适当进行清洁验证了吗？
Do you perform a process validation properly according to GMP Guidelines (revised in 2010)?
您按照药品GMP(2010年修订)的要求适当进行工艺验证了吗？
Do you perform a validation for water system properly according to GMP Guidelines (revised in 2010)?
您按照药品GMP(2010年修订)的要求对水系统进行适当确认了吗？
It is a legal requirement of the state for pharmaceutical enterprises to qualify GMP authentication.
通过《药品生产质量管理规范》认证，是国家对制药企业的法规性要求。
GMP is an internationally recognized quality control of pharmaceutical production and the basic norms.
GMP是国际公认的药品生产和质量管理的基本准则。
In strict accordance with GMP standards for veterinary drug enterprise planning, design, construction.
企业严格按照兽药GMP标准规划、设计、建设。
Is the QC laboratory of your company well-organized according to the GMP Guidelines (revised in 2010)?
您公司质控实验室工作是按照药品GMP(2010年修订)要求妥善组织的吗？
A distributor who only adds a label bearing their name and address is exempt from the GMP requirements.
经销商，如果只将他们的名称和地址添加在标签上，可以豁免GMP要求。
Maintenance - the machine is in line with the GMP requirements, easy disassembly, cleaning maintenance.
维护情况——本机符合GMP要求，可轻松拆卸、清洗维护。
In addition, manufacturers should keep on file records of any specific GMP exemption granted to them by FDA.
此外，制造商应保留fda授予的任何特定GMP豁免的文件记录。
The present study shows that GMP method is an efficient freezing method for porcine oocyte cryopreservation.
研究表明，GMP法为一种有效的猪卵母细胞冷冻保存方法。
Do you have a deviation investigation procedure following requirements of the GMP Guidelines (revised in 2010)?
您是按照药品GMP(2010年修订)要求制定的偏差调查程序吗？
Objective:To observe the change of GMP-140, GP53 on platelets in patients with TIA and its clinical significance.
目的：观察短暂脑缺血发作（TIA）患者血小板颗粒膜糖蛋白GMP-140，GP53的变化及其临床意义。
Objective:To observe the change of GMP-140, GP53 on platelets in patients with TIA and its clinical significance.
目的：观察短暂脑缺血发作（TIA）患者血小板颗粒膜糖蛋白GMP-140，GP53的变化及其临床意义。
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