Finally: FDA publishes Guidance on Contracts
终于：FDA发布了合同指南

The US Food and Drug Administration (FDA) finalised its long awaited Guidance on Contract Manufacturer Quality Agreements. According to FDA it took this time to clarify differences between the draft from May 2013 and the final guidance.
美国FDA终于将等候多时的委托生产商质量协议指南定稿。FDA借此机会也说明了此指南最终稿与2013年5月草案之间的差异。

"In particular, our revisions clarified the scope and applicability of the guidance and key terms used in the guidance. Regarding scope and applicability, we have clarified that the guidance is limited to commercial manufacturing activities. Although the principles articulated may be useful in approaching quality agreements for other kinds of activities, such as clinical research, development, or distribution, these are outside the scope of this particular document," FDA said in theFederal Register.
FDA在联邦通讯上说，“我们的修订澄清了本指南的范围和适用性，以及指南中所用的关键术语。关于范围和适用性，我们已说过该指南只限于商业生产活动。虽然所述的原则可能也有助于其它类别的活动达成质量协议，如临床研究、研发或销售运输，但这些活动并不在此指南文件的范围以内”。

One point being discussed was the difference between the terms "owner" and "contract facility". In some comments received it was recommended to use the terms "contract giver" and "contract acceptor", though FDA said "these terms do not align with our goal of showing how the parties to a contract manufacturing arrangement can work together to define, establish, and document agreements that delineate manufacturing activities and ensure compliance with CGMP."
有一个讨论点是术语“所有者”和“受托场所”之间的差异。在有些收到的建议中，有人建议使用术语“委托方”和“受托方”，但FDA说“这些术语与我们的目标并不一致，无法展示出委托生产安排的各方可以共同工作，以定义、制订和记录协议，在其中说明生产活动和确保CGMP符合性。”

The FDA recommends that quality agreements should contain the following sections at a minimum:
FDA建议质量协议应至少包括以下部分：

purpose and scope of the agreement
协议的目的和范围
terms of the agreement, including its effective dates
协议的术语，包括其有效期
terms for dispute resolution
争议解决条款
responsibility of each respective party
相关各方的责任
change control and revision practices
变更控制和修订规范

"From a cGMP perspective, the most critical elements of a quality agreement are the sections delineating the parties' respective responsibilities and the discussion of change control," FDA states.
“从CGMP的角度来看，质量协议最关键的因互是描述各方相关责任以及讨论变更控制的部分”，FDA说。

To get further details please see the FDA "Contract Manufacturing Arrangements for Drugs: Quality Agreements Guidance for Industry".
更多细节参见上述网址。