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1·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。

2·Sterile devices are never exempted from GMP requirements.

消毒器械从不受GMP要求豁免。

3·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？

4·Be responsible for quality deviation and GMP corrective action.

负责质量偏差和GMP纠正行动。

5·These contract laboratories are not subject to routine GMP inspections.

这些合同式实验室不必接受GMP的例行检查。

6·Participate in internal GMP inspection for all manufacturing functions.

参与所有生产操作的GMP内审。

7·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。

8·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。

9·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。

10·OBJECTIVE: To provide reference for meeting with GMP requirement in hospital preparations.

目的：为医院制剂达到GMP要求提供参考建议。