20160120 ECA新闻：质量协议最佳规范指南发布 - 药群论坛

In the EU GMP Guide Chapter 7 on Outsourced Activities, expectations regarding quality contracts are clearly defined. In the US, not much detail was provided so far. In 2013, the U.S. Food and Drug Administration (FDA) has published the draft Guidance for Industry "Contract Manufacturing Arrangements for Drugs: Quality Agreements". CFR regulations do not explicitly require contract partners to document their respective responsibilities in contract manufacturing arrangements, but the regulations do require that Quality Unit responsibilities and procedures are in writing (21 CFR 211.22(d)).

在EU GMP指南第7章关于外包活动里，清楚给定了关于质量协议的要求。在美国，迄今为止并未给出过详细的要求。在2013年，美国FDA公布了“行业指南：药品的合同生产安排：质量协议”。CFR法规并没有明确要求合同伙伴在合同生产安排中记录其相应的职责，但是法规的确要求有书面的质量部门职责和程序（21CFR 211.22(d)）。

Now, a new Best Practice Guide has been published by Rx-360. Rx-360 is a non-profit organisation with the goal to support the pharmaceutical and biotech industry enhancing the security of the pharmaceutical supply chain. It is managed by members from the industry including both manufacturers and suppliers. Their Supplier-Led Working Group has developed a Best Practices for Quality Agreements Guide and published it on the Rx-360 website. The Intention of this Guide is "to assist both customers and suppliers in efficiently managing the initiation, negotiation, implementation, and ongoing maintenance of quality agreements". The goal is to help facilitating a more efficient and effective quality agreement negotiation process.

现在，RX-360公布了一份新的最佳规范指南。RX-360是一个非盈利组织，其目标是支持制药和生物技术行业，提高药品供应链的安全性。它由来自生产商和供应商的成员进行管理。其供应商领导工作组起草了质量协议最佳规范指南，将其公布在RX-360网站上。指南的目的是“协助客户和供应商有效管理质量协议的起草、磋商、实施和持续维护”。其目标是帮助促进更有效更高效的质量协议磋商过程。

The document follows a given process flow from scope and structure throughout the contents of the agreement to review and maintenance. This helps the user to quickly browse to the section needed, if necessary. Enclosed in the process flow are best practices and tips. In addition, appendices offer a set of comprehensive tools like, for example:

文件是按一个流程顺序展开的，从范围、结构到协议的内容，到审核的维护。它有助于用户快速浏览所需部分。在流程中附入了最佳规范和提示。另外，附录提供了一系列综合工具，如：