纠正措施与预防措施处理规程翻译Word文件下载.docx

1、the quality management system, we specially formulated correctivemeasures and prevention measures （Corrective Action & PreventiveAction, 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, impleme

2、ntationand closed-loop confirmation which do not meet the CAPA in theGMP2.2 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 theproblem and is not related to the batch product quality in productionquality activities, we c

3、an not perform the procedure. But the case thatappears more than once should be reflected in BPR and other relatedrecords.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 informationadministrator, site QA, QA competent, Minister of quality ma

4、nagement,Quality attorney4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. Requirementsstated, generally implied or obligatory requirements or expectations,such as regulations, industry standards, company documentsrequirements.潜在不符合：存

5、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 notbeen revealed, probable or imminent can not meet the requirements ofthe situation had adverse trends, such as the quality of products, thepotential impact of the risk assessment

6、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 measures: To avoid the （potential） nonconformitiesthat has occurred to deteriorate or produce further negative impacton related equipment, materials, products, and take emergencymeasures.纠正措施（CA ）：为消除已发现的不符合或其他不期望情况的原因所采取

7、的措施，以防止 问题的再次发生。Corrective Action （CA）: To eliminate the nonconformities thathas been found or the cause of other undesirable situation, andtake the measures to prevent the problem from happening again.预防措施（PA）：为消除潜在不符合或其它潜在不期望情况的原因所采取的措施，防止 问题的发生。The precautions （PA）:take the measures to prevent th

8、e problem from happening.（潜在）不符合分类：The classification of （potential） nonconformities:关键-Key确认违反法定工 艺、超出国家法定 质量标准或违反药品生产相关法规规定，将会造成产品整批报废、产品召回、重大客户投诉、药监部门吊销生产许可证、收回GMP证书及批件等后果，关系到患者的生命安全、企 业的品牌形象和 产品的市场影响。Verify that the violation of the statutory process beyondnational statutory quality standards or

9、 violation of pharmaceuticalproduction and related regulations, the entire batch will causeproduct obsolescence, product recall, a major customer complaintsand Drug Administration shall revoke the production license,recover GMP certificates and documents issuedconsequencesrelatedto the lives and saf

10、ety of the patients, themarket impact of the companys brand image and products.重要- Important关键性物料、设备、厂房、工艺、介质、环境发生偏移，导致或可能 导致产品内、外在质量受到某种程度的影响，超出内控质量标准，存在导致或可能将会 导致产品返工、重新 处理等质量风险、违反GMP、工艺的事件，直接影响企 业的正常运 转。Critical materials, equipment, plant, technology, media,environmental shift, caused or may cau

11、se the product to be subjectto some degree of external quality impact beyond the internalquality control standards, there is cause or likely will lead toproduct rework, re-processing and quality risk, in violation of theGMP, craft events directly affect the normal operation of theenterprise.一般- Gene

12、ral经确认不属于上述两种范 围，属于SOP符合性问题（即是否严格按 SOP执行）、适用性问题（即SOP内容是否很适用于 实际操作）及有效性问题（即按照SOP要求执行，检查实施后的效果是否很有效）等，不会导致产品返工和重新 处理，但存在违反GMP要求且属于 GMP 认证检查 条款中的一般缺陷。Sure you do not belong to these two ranges, belongs SOPcompliance issues （ie, whether strictly performed according toSOP） applicability （ie, the the SOP

13、content is very applicable inpractice） and the effectiveness of （implementation requirements inaccordance with SOP enforcement, inspectionafter effect is veryeffective） will not cause the product to rework and re-processing,but a violation of the requirements of GMP and belong to thedefects in the general terms of the GMP certification examination.4.2 （潜在）不符合信息来源（Pote