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发表于 2023-8-25 16:30:04
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The Contract 合同
• 7.14 A Contract should be drawn up between the Contract Giver and the Contract Acceptor which specifies their respective responsibilities and
communication processes relating to the outsourced activities. Technical aspects of the Contract should be drawn up by competent persons
suitably knowledgeable in related outsourced activities and Good Manufacturing Practice. All arrangements for outsourced activities must be in
accordance with regulations in force and the Marketing Authorisation for the product concerned and agreed by both parties.在合同委托方和合
同受托方之间应制定一份合同,明确各自与外包活动有关的责任和沟通过程。合同的技术方面应由具有相关外包活动和良好生产规范
相关知识的胜任人员制定。所有外包活动的安排必须符合有效的法规和相关产品的上市许可,并经双方同意。
• 7.15 The Contract should describe clearly who undertakes each step of the outsourced activity, e.g. knowledge management, technology transfer,
supply chain, subcontracting, quality and purchasing of materials, testing and releasing materials, undertaking production and quality controls
(including in-process controls, sampling and analysis).合同应清楚地描述由谁承担外包活动的每一步,例如:知识管理、技术转让、供应
链、分包、材料的质量和采购、检测和发放材料、进行生产和质量控制(包括过程控制、抽样和分析)。
• 7.16 All records related to the outsourced activities, e.g. manufacturing, analytical and distribution records, and reference samples, should be
kept by, or be available to, the Contract Giver. Any records relevant to assessing the quality of a product in the event of complaints or a
suspected defect or to investigating in the case of a suspected falsified product must be accessible and specified in the relevant procedures of the
Contract Giver.与外包活动有关的所有记录,如制造、分析和分发记录以及参考样品,应由委托方保存或提供给委托方。在投诉或疑
似缺陷情况下评估产品质量或在疑似伪造产品情况下进行调查的任何记录必须可获得并在合同授予方的相关程序中加以规定。
• 7.17 The Contract should permit the Contract Giver to audit outsourced activities, performed by the Contract Acceptor or his mutually agreed
subcontractors合同应允许委托方对由合同接受方或双方同意的分包方实施的外包活动进行审计 |
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