ISO 22716: 2007 化妆品良好生产规范 中英文对照（设备、原料和包装材料）

官方英文版：

https://www.iso.org/standard/36437.html

官方中文版：

https://std.samr.gov.cn/hb/search/stdHBDetailed?id=8B1827F1C68ABB19E05397BE0A0AB44A

Cosmetics — Good Manufacturing Practices (GMP) — Guidelines on Good Manufacturing Practices

化妆品良好生产规范

5 Equipment 设备

5.1 Principle 原则

Equipment should be suitable for the intended purpose and capable of being cleaned and, if necessary, sanitized and maintained. This clause applies to all equipment within the scope of these guidelines. If automated systems are introduced into activities described in these guidelines, they should take into account the application of the given relevant principles.

设备应满足预期目标的需要，易于清洗及必要的消毒和维护。本条适用于本标准范围内的所有设备。这些原则同样适用于本标准相关活动中使用的自动化系统。

5.2 Equipment design 设备设计

5.2.1 Production equipment should be designed to prevent contamination of the product.

生产设备的设计应防止产品受到污染。

5.2.2 Bulk product containers should be protected from air contaminants, such as dust and moisture.

盛放的容器应保护半成品免受空气中灰尘和湿气等污染。

5.2.3 Transfer hoses and accessories that are not in use should be cleaned and, if necessary sanitized, kept dry and protected from dust, splash or other contamination. 

暂时不用的转接软管和配件应进行清洁和必要的消毒，保持干燥，免受灰尘、喷溅物或其他污染。

5.2.4 The material used in the construction of equipment should be compatible with products and the cleaning and sanitizing agents.

制作设备的材料应与盛放的产品以及所使用的清洁剂和消毒剂相容。

5.3 Installation 安装

5.3.1 The design and the installation of equipment should ease its drainage in order to facilitate cleaning and sanitization.

设备的设计与安装应易于排空，以便清洁消毒。

5.3.2 Equipment should be placed so that movement of materials, mobile equipment and personnel do not pose a risk to quality.

设备的摆放应避免物料和设备的移动、人员的走动对质量造成影响。

5.3.3 Reasonable access under, inside and around equipment should be provided for maintenance and cleaning.

设备的底部、内部和周围应便于维护和清洁。

5.3.4 Major equipment should be readily identifiable.

主要设备应易于识别。

5.4 Calibration 校准

5.4.1 Laboratory and production measuring instruments that are important for the quality of the product, should be calibrated regularly.

与产品质量有重要关系的实验室和生产的测量器具应定期校准。

5.4.2 If results of calibration are out-of-acceptance criteria, measuring instruments should be appropriately identified and removed from service.

校准结果不符合接收标准的测量器具应做好标识并停止使用。

5.4.3 An out-of-calibration condition should be investigated to determine if there is any impact to the quality of the product and appropriate steps taken based on this investigation.

当发现测量器具不符合要求时，应调查是否对产品质量造成影响，并根据调查结果采取适当措施。

5.5 Cleaning and sanitization 清洁消毒

5.5.1 All equipment should be subject to an appropriate cleaning and, if necessary, sanitization programme.

应对所有设备制定清洁及必要的消毒程序。

5.5.2 Cleaning and sanitizing agents should be specified and effective.

应规定所使用的清洁剂及消毒剂并保证其有效性。

5.5.3 Where equipment is assigned to continuous production or production of successive batches of the same product, equipment should be cleaned and, if necessary, sanitized at appropriate intervals.

若设备连续生产，应在适当的时间间隔对设备进行清洁和必要的消毒。

5.6 Maintenance 维护

5.6.1 Equipment should be regularly maintained.

设备应定期维护。

5.6.2 Maintenance operations should not affect the quality of the product.

设备的维护不应对产品质量造成影响。

5.6.3 Defective equipment should be identified accordingly, excluded from use and isolated if possible.

发生故障的设备应加以标识并不得使用，可能时予以隔离。

5.7 Consumables 消耗品

Consumables used for equipment should not affect the quality of the product.

用于设备的消耗品不得影响产品质量。

5.8 Authorizations 权限

Equipment or automated systems used in production and control should be accessed and used by authorized personnel.

用于生产和控制的设备和自动化系统应由经授权的人员使用。

5.9 Back-up systems 备用系统

Adequate alternative arrangements should be available for systems which need to be operated in the event of a failure or breakdown. 

发生故障情况下仍需要使用的系统应有充分的替代措施。

6 Raw materials and packaging materials 原料和包装材料

6.1 Principle 原则

Raw materials and packaging materials that are purchased should meet defined acceptance criteria relevant to the quality of finished products.

采购的原料和包装材料应符合规定的与成品质量相关的接收标准。

6.2 Purchasing 采购

Purchasing of raw materials and packaging materials should be based on:

原料和包装材料的采购应基于：

a) evaluation and selection of the supplier;

对供应商的评估和选择；

b) establishment of technical clauses such as type of selection to be conducted, acceptance criteria, actions in the case of defect or modifications, transport conditions;

技术性条款的设立，如选择类型、接收标准、出现缺陷或修改时采取的措施以及运输条件等；

c) setting of relations and exchanges between the company and supplier such as questionnaire, assistance and audits.

与供应商建立联系和沟通，如调查问卷、协助和审核等。

6.3 Receipt 接收

6.3.1 The purchase order, the delivery note and the delivered materials should match.

采购订单、交付票据和交付的物料应相符合。

6.3.2 The integrity of the raw materials and packaging materials shipping containers should be checked visually. If necessary, additional checks of transport data should be performed.

应检查原料和包装材料运输包装的完整性。必要时应对运输资料进行检查。

6.4 Identification and status 标识与状态

6.4.1 Containers of raw materials and packaging materials should be labelled in order to identify the material and the batch information.

原料和包装材料的容器应加贴标签，以便识别该批物料的相关信息。

6.4.2 Raw materials and packaging materials showing defects that might affect product quality should be held pending a decision.

可能影响产品质量的有缺陷的原料和包装材料应予以控制等待处理。

6.4.3 Raw materials and packaging materials should be identified in an appropriate way according to their status such as accepted, rejected or quarantined. Other systems can replace this physical system of identification, if they ensure the same level of assurance.

原料和包装材料的状态应有适当标识，如接收、拒收或待处理。如能确保具有同等效果，其他系统可以取代物理标识系统。

6.4.4 Identification of raw materials and packaging materials should contain the following information:

原料和包装材料的标识应包含以下信息：

a) name of the product marked on the delivery note;

交付票据上载明的产品名称；

b) name of the product as given by the company, if different from the name given by the supplier and/or its code number;

公司使用的产品名称（如与供应商提供的名称不同）和（或）其代码；

c) date or number of receipt, if appropriate;

适用时应提供收据的日期或号码；

d) supplier’s name;

供应商名称；

e) batch reference given by the supplier and the one given at receipt, if different.

供应商提供的批号，若不同，应同时提供接收时分配的批号。

6.5 Release 放行

6.5.1 Physical or alternative systems should be set up to ensure that only released raw materials and packaging materials are used.

应建立物理或其他系统，确保只有经放行的原料和包装材料才能使用。

6.5.2 The release of materials should be carried out by the authorized personnel responsible for quality.

只有经授权的质量负责人员才有权放行原料和包装材料。

6.5.3 Raw materials and packaging materials can be accepted on the basis of the supplier certificate of analysis only if there are established technical requirements, experience and knowledge of the supplier, supplier audit and agreed supplier’s test methods.

只有当建立了技术要求、供应商具备相关的经验和知识且经过审核、供应商的试验方法经认定，才能根据供应商的分析报告接收原料和包装材料。

6.6 Storage 储存

6.6.1 Storage conditions should be appropriate for each raw material and packaging material.

原料和包装材料应在适宜的条件下储存。

6.6.2 Raw materials and packaging materials should be stored and handled in a manner appropriate to their characteristics.

原料和包装材料应根据其特性进行储存和处理。

6.6.3 Specific storage conditions should be respected and monitored, where appropriate.

对有特殊储存要求的应按规定条件储存，并对储存条件实施监控。

6.6.4 Containers of raw materials and packaging materials should be closed and should be stored off the floor.

原料和包装材料的容器应密闭，并与地面保持一定距离。

6.6.5 When raw materials and packaging materials are repacked, they should carry the same labelling as at origin.

若原料和包装材料重新包装，应加贴与原来一样的标签。

6.6.6 When raw materials and packaging materials are quarantined or rejected, they should be stored in their respective physical locations or by using any other system providing the same level of assurance.

待处理或拒收的原料和包装材料应分区存放，或采取其他有效措施避免混淆。

6.6.7 Measures should be set up to ensure stock turnover. Except in special circumstances, stock rotation should ensure that the oldest released stock is used first.

应采取措施确保库存周转率。除特别情况，应采用先进先出的原则。

6.6.8 Periodic inventory should be performed to ensure stock reliability. Any significant discrepancy should be investigated and corrective action taken.

应定期进行盘点，确保库存可靠性。应对重大差异进行调查并采取纠正措施。

6.7 Re-evaluation 再评估

A system should be set up to re-evaluate materials as appropriate to determining their suitability for use, after a defined period of storage. The system should be set up so as to prevent the use of materials which require re-evaluation.

应建立再评估系统，对超过规定保存期限的物料再评估，以确定是否可以使用。该系统应能防止误用需要再评估的物料。

6.8 Quality of water used in production 生产用水质量

6.8.1 The water treatment system should supply a defined quality of water.

水处理系统应提供符合质量要求的水。

6.8.2 Water quality should be verified by either testing or monitoring of process parameters.

应通过试验或监控过程参数验证水质。

6.8.3 The water treatment system should permit sanitization.

水处理系统应允许进行消毒。

6.8.4 Water treatment equipment should be set up so as to avoid stagnation and risks of contamination.

水处理设备的安装应避免积水及受污染

6.8.5 Materials used in water treatment equipment should be selected to ensure that water quality is not affected. 

应确保水处理系统使用的材料不会影响水质。