纠正措施与预防措施处理规程-翻译

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. \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 measures: To avoid the (potential) nonconformities that has occurred to deteriorate or produce further negative impact on related equipment, materials, products, and take emergency measures.

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的措施，以防止问题的再次发生。

Corrective Action (CA): To eliminate the nonconformities that has been found or the cause of other undesirable situation, and take 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): To eliminate the nonconformities that has been found or the cause of other undesirable situation, and take the measures to prevent the 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 beyond national statutory quality standards or violation of pharmaceutical production and related regulations, the entire batch will cause product obsolescence, product recall, a major customer complaints and Drug Administration shall revoke the production license, recover GMP certificates and documents issued consequencesrelated to the lives and safety of the patients, the market impact of the company's 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 cause the product to be subject to some degree of external quality impact beyond the internal quality control standards, there is cause or likely will lead to product rework, re-processing and quality risk, in violation of the GMP, craft events directly affect the normal operation of the enterprise. —一般 - General

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 SOP compliance issues (ie, whether strictly performed according to SOP) applicability (ie, the the SOP content is very applicable in practice) and the effectiveness of (implementation requirements in accordance with SOP enforcement, inspectionafter effect is very effective) will not cause the product to rework and re-processing, but a violation of the requirements of GMP and belong to the defects in the general terms of the GMP certification examination. 4.2 （潜在）不符合信息来源

(Potential) noncomformities with the sources of information 4.2.1 公司内部质量检查发现的（潜在）不符合的信息；

Internal quality check found the information does not meet the (potential); 4.2.2 外部质量检查发现的（潜在）不符合的信息；

External quality check found that the information does not meet the (potential); 4.2.3 顾客、相关方投诉产品缺陷、产品召回的相关信息； Customers complain of product defects, product recall information; (Potential) does not comply with the information found in the

4.2.4 质量管理过程中发现的（潜在）不符合的信息； Quality management process;

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