化妆品原料的质量对于保证化妆品和相关的个人防护用品的安全、质量和功效是至关重要的。化妆品原料有着范围广泛的用途，是化妆品配方的主要成份。因此，应用化妆品原料适用的良好操作规范（GMP）是必不可少的。

EFfCI（European Federation for Cosmetic Ingredients）是欧洲化学和天然原料行业协会的英文简称，是欧洲化妆品行业的供应商和服务提供商联盟。EFfCI于2000年成立，代表了欧洲超过100家化妆品原料公司的集体利益。其成员包括BASF、BIOCHIM、CRODA、GATTEFOSSE、RES PHARMA INDUSTRIALE、SABO、VEVY EUROPE等欧洲各国知名化妆品原料商。

EFfCI化妆品原料GMP，是由EFfCI发布的认证标准，其根本理念，是为化妆品原料制造商提供一个更合适的、有别于化妆品的、具有可操作性的GMP执行工具。

EFfCI非常重视最新评论，以作为EFfCI GMP指南进一步发展的输入。自2005年成功推行、2008年更新认证计划和标准以来，EFfCI:2012 GMP是印刷发行的第三版标准，完全整合了ISO9001:2008标准的内容，在确保反映ISO9001标准最新版本内容的同时，还参考了药品和食品GMP要求，加入了质量风险管理方法，以帮助化学合成和相关制造过程执行适当的GMP原则。新版标准中新增的附件，陈述了已经获得ISO9001证书的组织，如何通过第三方认证机构按照标准要求获取证书，以展示他们的产品是按照EFfCI GMP指南要求精制的。

EFfCI:2012 GMP是最适合化妆品原料供应商应用的GMP标准，有别于化妆品最新的GMP标准ISO22716:2007，EFfCI:2012 GMP标准完全基于ISO9001:2008标准框架，不仅注重化妆品原料生产的质量确保，而且关注化妆品原料生产商业绩改进、风险管理和具体管理工具应用。

同时，EFfCI:2012 GMP不是单一的GMP认证标准，还包括了EFfCI对第三方认证机构的认可管理要求、对审核员的管理和培训要求，以及认证申请企业的基本要求，是化妆品行业最为完整、系统和严苛的GMP标准。

截止2013年3月8日，EFfCI在全球认可的GMP证书仅有18张，大部分由欧洲著名的化妆品原料商BASF、CRODA、GATTEFOSSE、RES PHARMA INDUSTRIALE、SABO、VEVY EUROPECORDA等持有。

有效运行EFfCI:2012 GMP，通过Intertek认证并获得Intertek颁发的EFfCI GMP证书，不仅可以让化妆品原料生产企业更好地提升GMP管理，为拓展非处方药品类化妆品原料生产作好管理准备，而且可在同行业树立权威形象，更好地扩大在全球化妆品品牌持有方和/或生产商中的知名度，为企业获得更佳业绩创造契机。

由此可见，获得EFfCI GMP认证不仅是顺应世界化妆品质量要求的趋势，更是化妆品原料生产厂商将产品销往全球的通行证。

我们的解决方案

EFfCI:2012 GMP是印刷发行的第三版标准，为化妆品原料生产实施GMP确定了最低的规范要求。该指南适用于化妆品原料的生产，在生产过程中体现GMP质量管理。该指南将成为一个国际标准用以判断化妆品原料生产工厂是否充分满足GMP规范要求。该指南规范了化妆品原料制造商的管理要求、人员卫生管理、变更管理、厂房设施、工作环境、生产与服务的提供控制、产品的标识与追溯性、产品的监视与测量、不合格品的控制等内容。

▲ 实施EFfCI GMP具有以下优点：

* 确保产品安全

* 提升公司产品质量管理水平

* 降低产品对消费者造成的伤害或死亡的风险，保障消费者的使用安全和健康

* 消除危险事故

* 降低产品公众回收的风险

* 有效控制成本和国际认可

* 增强产品竞争力

▲EFfCI GMP主要内容（部分）

人员卫生

在化妆品原料暴露的环境，员工穿戴保护性衣物，如头套、面罩、手套，必要时戴袖套。首饰以及其他易脱落物应去除或采取保护性措施，防止其混入化妆品原料中。员工应养成良好的卫生习惯。

变更控制

对影响化妆品原料质量的变更应建立文件化的变更程序，明确评估和批准变更的权责。评估与批准变更应在变更实施前完成。质量部门应对可能影响化妆品原料质量的变更进行评估。

厂房设施

厂房设施应进行控制管理、清洁和维护以避免原料、中间体和化妆品原料污染（包括尘埃粒子、微生物控制和必要时的水质控制）。工厂应基于预期用途的厂房设施执行并记录风险评估以识别因厂房设施的缺陷而引起的化妆品原料的污染的区域。

工作环境

工作环境应进行管理以最大限度减少化妆品原料的污染。文件化的风险评估应执行以确定必要的控制。

生产与服务提供

在制造及包装的每一阶段，应采取措施保证成品符合其应有特性；所有制造加工应根据生产文件要求进行，并且需要过程确认及过程控制。

标识与追溯性

标识与追溯性是明确的要求。质量管理体系包括记录应能从产品追溯到原料与客户。

产品的监控与测量

书面的程序应建立以监控化妆品原料的质量状况。

不合格品的控制

应有不合格品的控制。应由授权人员对拒收的物品进行分析研究；对返工产品实施控制，并有授权人员检查以验证其符合性。

总之，EFfCI GMP是针对化妆品原料的特点对生产厂家的厂房设施、人员、工厂管理及控制等软硬件两方面所做出的具体要求。

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International Cosmetic Ingredients GMP Guide – EFfCI GMP

Challenge

The quality of cosmetic ingredients is crucial to ensure the safety, quality and effects of cosmetics and related personal protection products. Cosmetic ingredients have wide ranges of usages and are the main ingredients in the formulas of cosmetics. Therefore, GMP for cosmetic ingredients is indispensable.

The European Federation for Cosmetic Ingredients (EFfCI) is a federation of European suppliers and service providers of the cosmetic industries, and represents the collective interests of more than 100 European cosmetic ingredients companies. It was founded in 2000, and the members include famous cosmetic ingredients companies in European countries such as BASF, BIOCHIM, CRODA, GATTEFOSSE, RES PHARMA INDUSTRIALE, SABO and VEVY EUROPE etc.

EFfCI Cosmetic Ingredients GMP is a certification standard published by EFfCI, aims to provide a GMP implementing tool which is more suitable and workable for cosmetics ingredient manufacturers and different from that of the cosmetics.

EFfCI pays great attention to the latest comments and take that as the input for further development of EFfCI GMP Guide. Since its introduction in 2005 and updating in 2008, the Guide has come to the third version as EFfCI:2012 GMP, which integrates ISO9001:2008, keeps in alignment with the latest edition of ISO 9001 standards, and take reference of the medicine and food GMP requirements and add in quality risk management methods to help the chemical synthesis and related manufacturing processes to implement proper GMP principles. The newly added annex of the new standard lists the organizations which have obtained ISO9001 certification, and shows how to obtain the certification according to the requirements through third party certification body, so as to demonstrate that their products are produced strictly as per the EFfCI GMP Guide.

EFfCI:2012 GMP, different form the latest cosmetic GMP ISO22716:2007, is completely based on the framework of ISO9001:2008 and most suitable for cosmetic ingredients suppliers. It emphasizes on not only the quality assurance of cosmetic ingredients manufacture, but also the performance improvement, risk management and practical management tools of cosmetic ingredients manufacturers.

At the same time, EFfCI:2012 GMP is not a single GMP certification standard, it also contains EFfCI’s requirements for accreditation management of the third party certification bodies, requirements for the management and training of auditors, and basic requirements for the companies applying for certification. It is the most complete, systematic and strictest GMP standard in the cosmetic industry.

Until March 8th, 2013, there were only 18 GMP certificates worldwide recognized by EFfCI, and most of them belong to famous European cosmetic ingredients suppliers such as BASF, CRODA, GATTEFOSSE, RES PHARMA INDUSTRIALE, SABO and VEVY EUROPECORDA etc.

To implement EFfCI:2012 GMP, and pass Intertek certification and obtain the EFfCI GMP certificate issued by Intertek will help the company to improve their GMP management, to be better prepared for the manufacture of OTC drug cosmetic ingredients. Also, it helps the cosmetic ingredients suppliers to enhance company image and attract more cosmetic brand holders and manufacturers.

From above, EFfCI GMP certification is not only a world trend of cosmetic quality requirements, but also a passport for cosmetic ingredients manufacturers to succeed in international market.

Our Solution

EFfCI:2012 GMP is the third edition of the International Cosmetic Ingredients GMP Guide, and sets a baseline guide that defines the extent and point of application of fundamental GMP principles for cosmetic ingredient manufacture. The guide is applicable to the manufacture of cosmetic ingredients intended for use in cosmetic products, and reflects the GMP quality management in the manufacturing process. The Guild will become an international standard, and be used to assess if the cosmetic ingredients manufacturer has fully meet the requirements of GPM. The guide sets requirements for management, personnel hygiene, change control, infrastructure, work environment, production and service supply control, identification and traceability of product, monitoring and measurement of product, control of nonconforming products etc.

▲ The Benefits of EFfCI GMP

* Ensure product safety

* Improve quality management

* Reduce injure or death risks of the product and protect safety and health of the consumer

* Eliminate dangers and accidents

* Reduce public recall risks

* Effective control of cost and international recognition

* Improve product competitiveness

▲Main Contents of EFfCI GMP (Part)

Personnel Hygiene

Where cosmetic ingredients are exposed to the environment, personnel should wear protective apparel such as head, face, hand, arm coverings as necessary, and jewellery and other loose items should be removed or covered to protect the cosmetic ingredient. Personnel should practice good sanitation and health habits.

Change Control

There shall be a documented procedure defining the responsibilities and requirements for the evaluation and approval of changes that may impact the quality of the cosmetic ingredient. The quality unit shall evaluate changes that may impact on the quality of the cosmetic ingredient.

Infrastructure

The infrastructure shall be managed, operated, cleaned and maintained to avoid raw material, intermediate and cosmetic ingredient contamination (including control of particulate matter, microbiological control and control of water quality where applicable). The organization shall conduct and record a risk assessment based on the organization’s intended use of the infrastructure to identify areas in which the cosmetic ingredient is at risk for contamination from deficiencies in buildings and/or facilities.

Work environment

The work environment shall be managed and controlled to minimize risks of cosmetic ingredient contamination. A documented risk assessment shall be carried out to determine the necessary controls.

Production and Service Provision

In every stage of production and packaging, proper measures shall be taken to ensure the finished products conforming to the characteristics they shall have. All production and processing shall carry through according to the production documents, and process confirmation and process control are necessary.

Identification and traceability

Identification and traceability are specified requirements; the quality management system shall include records that allow traceability of the cosmetic ingredient to raw materials and upstream to customers.

Monitoring and measurement of product

Written procedures shall be established to monitor and control the quality characteristics of cosmetic ingredients.

Control of nonconforming products

The organization shall deal with nonconforming products. The rejected products shall be analyzed by designated personnel. Reproduced products shall be monitored and inspected by designated persons to verify their conformity.

To sum up, EFfCI GMP standard is a set of specific requirements developed on basis of the characteristics of cosmetics ingredients for the hardware and software of a cosmetic ingredients factory including workshop, equipment, personnel, management and control etc.

Related Services

* GMPC (ASEAN, EU, US) / BRC / ISO22716 / EFfCI GMP certification and training

* Cosmetics testing

* Inspection

* Corporate social responsibility auditing

* GSV (Global Security Verification)......