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GMP消费品行业良好作业规范

日期:2020-09-14浏览次数:230次作者:中国验厂网

        继医药行业、食品行业和化妆品行业均有良好作业规范(GMP)后,消费品行业的一般产品类别也开始有适用的GMP。“消费品行业良好作业规范”,简称“GMP-CP”,是一套适用于多种消费品生产过程的质量管理体系。SGS GMP-CP审核可以帮助企业识别所有在生产和测试过程中可能影响产品质量的因素。
        GMP是在食品、药品、化妆品以及医疗器械的生产过程中经常出现的一个词汇。SGS GMP-CP审核采用了GMP常用的过程控制标准,将其运用于消费品行业所有产品的生产,旨在帮助企业保护顾客的健康安全,生产优质的产品。
        SGS GMP-CP审核的益处
        通过SGS GMP-CP审核,您将获悉您的工厂在以下几个方面的表现:
        •是否有对生产流程进行了明确的规定和控制,并且确保符合相关规定;
        •生产流程的更改是否有进行评估;
        •工作流程和指导是否有用当地语言清晰地记录于书面文档中;
        •是否有对操作员进行工作流程的培训;
        •是否有对生产流程的所有步骤保质保量地完成记录并作了保存;
        •是否有可用于批量追踪的生产记录;
        •是否具有产品召回系统;
        •是否有对投诉进行处理,是否有对质量缺陷的原因进行调查,是否有采取适当的措施
        来避免重复出现同样的问题。

        SGS GMP-CP审核内容和评分实例


        SGS的审核服务
        •为您提供关GMP标准的的审核服务;
        •检验公司政策和流程的执行情况,检查GMP规定的所有应该遵守GMP良好作业规范的场所是否符合GMP要求;
        •根据GMP审核清单上的每一项来审核工厂的实际情况,并列出符合项、一般不符合项、重大不符合项和关键性不符合项,评出等级(A到不合格)。买家在选择供应商时,可以参考此得分等级。

       英文版

        GOOD MANUFACTURING PRACTICES –CONSUMER PRODUCTS (GMP-CP)
        There are Good Manufacturing Practices (GMP) for drugs, food and cosmetics, and they are now available for consumer products in general categories.“Good Manufacturing Practices –Consumer Product” or “GMP-CP” is an overall quality system covering the manufacturing processes for various types of consumer products. The system built by SGS has acted as guidance in outlining the aspects of production and testing which may impact on the quality of a product.
        GMP has been a widely used term in the manufacturing of food products,pharmaceutical products, cosmetic products and medical devices; SGS has adopted the same level of process control requirement and now made it available for all consumer products.This development uses the basic concepts of GMP, aiming to safeguard the health of the customer and producing good quality products upon its implementation.
        After the assessment, SGS will be able to tell you about the factory’s performance in the following respects:
        •Manufacturing processes are clearly defined, controlled and validated to ensure consistency and compliance with specifications.
        •Changes in the manufacturing processes are evaluated.
        •Working procedures and instructions are written in a clear and unambiguous manner, in local language.
        •Operators are trained to carry out document procedures.
        •Records are kept and maintained to demonstrate that all the required steps are in fact taken and that the quantity and quality are as expected.
        •Records of manufacture are available that enable batch traceability.
        •A product recall system is readily available.
        •Complaints are examined, the causes of quality defects are investigated,and appropriate measures are taken to prevent recurrence.
        SGS Good Manufacturing Practice – Consumer Products audit coverage and scoring example:       

        SGS’S SERVICES:AUDITING
        •To provide you with the general coverage of GMP criteria.
        •To verify if company policies and procedures are being followed,assess sites’ GMP practices,and verify that required systems and controls are in place and in compliance with general GMP requirements.
        •To verify the factory’s actual situation against each item in the checklist and appraise it as one of the following: Compliance, Minor Non-compliance, Major Non-compliance and Critical Non-compliance. An overall percentage score and grade(from A to Fail) and hence the level of performance would then come into view. Buyers could use this scoring system as a benchmark when comparing the performance of their suppliers.

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