EU 投诉 产品缺陷和产品召回.pdf

Personnel and Organization 人员和机构 8.1 Appropriately trained and experienced personnel should be responsible for managing complaint and quality defect investigations and for deciding the measures to be taken to manage any potential risk(s) presented by those issues, including recalls. These persons should be independent of the sales and marketing organization, unless otherwise justified. If these persons do not include the Qualified Person who is involved in the certification for release of the concerned product, the latter should be made formally aware of any investigations, any risk-reducing actions and any recall operations, in a timely manner. 应由经过适当培训和具备经验的人员负责管理投诉和质量缺陷调查，以及决定需 要采取的措施（包括召回），以管理这些问题暴露的所有潜在风险。这些人员应 独立于市场销售部门/组织，否则应另外论述。如果这些人员不包括放行受影响 产品的授权人，则该授权人应被及时地正式告知所有调查和降低风险的措施，以 及所有召回操作。 8.2 Sufficient trained personnel and resources should be made available for the handling, assessment, investigation and review of complaints and quality defects and for implementing any risk-reducing actions. Sufficient trained personnel and resources should also be available for the management of interactions with competent authorities. 应保证有足够的受过训练的人员和资源来处理、评估、调查和审核客诉和质量缺 陷，以及实施所有降低风险的措施。管理与药监当局之间沟通也应配备有足够的 受过培训的人员和资源。 8.3 The use of inter-disciplinary teams should be considered, including appropriately trained Quality Management personnel. 应考虑使用跨学科团队，包括接受过适当训练的质量管理人员。 8.4 In situations in which complaint and quality defect handling is managed centrally within an organization, the relative roles and responsibilities of the concerned parties should be documented. Central management should not, however, result in delays in the investigation and management of the issue. 如果客诉和质量缺陷处理是由组织内集中管理，则要记录各相关方所担任的角色 和职责。不管如何组织，集中管理都不应该导致问题调查和管理的延迟。 Procedures for handling and investigating complaints including possible quality defects 处理、调查客诉包括可能的质量缺陷的程序