纠正措施预防措施处理规程翻译.docVIP

1 目的 为规范GMP运行过程产生的（潜在）不符合的处理行为，使药品生产符合法规、行业标准规定，降低产品缺陷率及偏差发生的机率，实现质量管理体系的持续改进，特制定纠正措施与预防措施（Corrective Action Preventive Action，以下简称CAPA）的管理程序。 To regulate the incongruent processing behavior generated in the GMP, and meet the drug production in line with regulations and industry standards, and reduce product defect rate and the probability of the deviation occurrence, and realize the continuous improvement of the quality management system, we specially formulated corrective measures and prevention measures (Corrective Action Preventive Action, hereinafter referred to as CAPA) management program. 2 适用范围 2.1 适用于药品GMP运行过程产生的各类（潜在）不符合的CAPA制定、实施及闭环确认。 Applies to all kinds of (potential) formulation, implementation and closed-loop confirmation which do not meet the CAPA in the GMP 2.2在生产质量活动中，能够立即采取应急措施解决问题且相关批次产品质量无影响，可以不执行该程序。但出现一次以上的除外，应在BPR等相关记录中体现。 That can take immediate emergency measures to solve the problem and is not related to the batch product quality in production quality activities, we can not perform the procedure. But the case that appears more than once should be reflected in BPR and other related records. 3 责任人 CAPA相关的执行部门人员、CAPA质量信息管理员、现场QA、QA主管、质量管理部部长、质量受权人 CAPA executive departments staff, CAPA quality information administrator, site QA, QA competent, Minister of quality management, Quality attorney 4 工作程序 4.1 相关定义 不符合：未满足要求。“要求”是指明示的、通常隐含的或必须履行的需求或期望，如法规、行业标准要求，公司文件要求等。 Nonconformities: not meeting requirements. Requirements stated, generally implied or obligatory requirements or expectations, such as regulations, industry standards, company documents requirements. 潜在不符合：存在于事物内部尚未显露出来的、有可能或即将不能满足要求的情况，如产品质量呈现不良趋势、经风险评估识别的潜在影响。 Potential nonconformities: that existing within the thing has not been revealed, probable or imminent can not meet the requirements of the situation had adverse trends, such as the quality of products, the potential impact of the risk assessment to identify. 应急措施：为避免已经发生的（潜在）不符合继续恶化或对相关设备、物料、产品产生进一步负面影响而采取的紧急处理措施。 Emergency