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。
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。
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。
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。
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 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？
The designation of a device as a "custom" or "customized" device does not confer a GMP exemption.
以定制或定制化所指定的器械并不授予GMP豁免。
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？
Understand and be able to apply, enforce, comply and meet all GMP standards and quality requirements.
理解并运用，加强，遵守及达成GMP标准及质量要求。
Also support for arbitrary precision Numbers will be added (using GMP), as the CLR has no support for them.
同时，由于CLR并不支持任意精度的数字，因此还会增加这一功能(使用GMP)。
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。
The QC Unit performs GMP Internal Audits periodically. A documented corrective action file is maintained.
定期有质量控制小组完成GMP的内审。保留更正行动的记录。
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。
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？
Do you have an OOS investigation procedure, which follows the requirements of the GMP Guidelines (revised in 2010)?
您是按照药品GMP(2010年修订)要求制定的超标检验数据调查程序吗？
Do you have a strict change control procedure, which follows the requirements of the GMP Guidelines (revised in 2010)?
您是否建立了符合药品GMP（2010年修订）要求且很严格的变更控制程序？
What is different about pharmaceutical and foods manufacturing and the challenges of implementing lean in GMP environment.
制药和食品行业有什么不同，在GMP环境中实施精益的挑战。
Ensure all the testing are performed in compliance with SOPs and regulatory requirements. Maintain GMP standards in the laboratory.
确保所有的测试遵循SOP和法规要求进行。维护实验室的GMP标准。
Ensure all the testing performed are in compliance with SOPs and regulatory requirements. Maintain GMP standards in the laboratory.
确保所有的测试遵循SOP和法规要求进行。维护实验室的GMP标准。
This workshop is specifically aimed at helping manufacturers working in a GMP environment to plan and implement change through lean.
此次研习会，是专门为了帮助在GMP环境下的工厂通过精益进行规划和实施改进。
For instance, a molecule that mimics cyclic di-GMP could be used to disable or disarm bacterial infections such as cholera, he said.
他举例说，如类似环状二gmp小分子可以用失活或消除诸如霍乱这样的细菌感染。
With regards to the GMP, this initial distributor is responsible for maintaining complaint files and general record keeping requirements.
相关于GMP，该一级经销商应负责建立投诉文档并负责保留通常记录的要求。
With regards to the GMP, this initial distributor is responsible for maintaining complaint files and general record keeping requirements.
相关于GMP，该一级经销商应负责建立投诉文档并负责保留通常记录的要求。
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