云计算：是否允许（GMP）监管机构检查CSP？

携手小灰灰

According to AMG § 64 (1) No. 6 (Arzneimittelgesetz - (Medicinal Product Act) German law based on European regulations/directives), establishments and enterprises are subject to supervision by the competent authorities where records are kept that relate to manufacturing, testing, storage, packaging, distribution, etc. This includes paper archives outside the establishment.

根据 AMG § 64 （1） No. 6 （Arzneimittelgesetz - （医药产品法） 基于欧洲法规/指令的德国法律），机构和企业受主管当局的监督，其中保存了与制造、测试、储存、包装、分销等相关的记录。这包括机构外的纸质档案。

The legislator had in mind paper archives outside the premises and documentation on tissue donations in facilities such as hospitals, but the wording of the law also includes the electronic archiving of the corresponding data, as this is generally permitted in accordance with the AMWHV (Arzneimittel- und Wirkstoffherstellungs-Verordnung - German law) and EU GMP guidelines.

立法者考虑了场所外的纸质档案和医院等设施中组织捐献的文件，但法律的措辞还包括相应数据的电子存档，因为这通常是根据 AMWHV（Arzneimittel- und Wirkstoffherstellungs-Verordnung - 德国法律）和欧盟 GMP 指南允许的。

In principle, the AMG requires clarification in some areas with regard to the handling of electronic data, as well as the processes of digitization and automation in the manufacture and testing of medicinal products.

原则上，AMG 要求在某些领域澄清电子数据处理以及医药产品制造和测试中的数字化和自动化过程。

（文章来源：ECA Academy）

胜利者

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