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      寧波亞川生物醫藥有限公司
      行業動態
      FDA發布了合同指南

      Finally: FDA publishes Guidance on Contracts
      終于:FDA發布了合同指南

      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.
      美國FDA終于將等候多時的委托生產商質量協議指南定稿。FDA借此機會也說明了此指南最終稿與2013年5月草案之間的差異。

      "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在聯邦通訊上說,“我們的修訂澄清了本指南的范圍和適用性,以及指南中所用的關鍵術語。關于范圍和適用性,我們已說過該指南只限于商業生產活動。雖然所述的原則可能也有助于其它類別的活動達成質量協議,如臨床研究、研發或銷售運輸,但這些活動并不在此指南文件的范圍以內”。

      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."
      有一個討論點是術語“所有者”和“受托場所”之間的差異。在有些收到的建議中,有人建議使用術語“委托方”和“受托方”,但FDA說“這些術語與我們的目標并不一致,無法展示出委托生產安排的各方可以共同工作,以定義、制訂和記錄協議,在其中說明生產活動和確保CGMP符合性。”

      The FDA recommends that quality agreements should contain the following sections at a minimum:
      FDA建議質量協議應至少包括以下部分:

      purpose and scope of the agreement
      協議的目的和范圍
      terms of the agreement, including its effective dates
      協議的術語,包括其有效期
      terms for dispute resolution
      爭議解決條款
      responsibility of each respective party
      相關各方的責任
      change control and revision practices
      變更控制和修訂規范

      "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.
      “從CGMP的角度來看,質量協議最關鍵的因互是描述各方相關責任以及討論變更控制的部分”,FDA說。

      To get further details please see the FDA "Contract Manufacturing Arrangements for Drugs: Quality Agreements Guidance for Industry".
      更多細節參見上述網址。

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