COSMOS认证和ISO22716认证用于化妆品行业，咨询辅导机构

7 Production 生产
7.1 Principle 原则
At each stage of manufacturing operations and packaging operations, measures should be taken to produce a finished
product that meets the defined characteristics.
在生产和包装的每个过程，需采取一些措施确保成品达到要求。
7.2 Manufacturing operations 制造作业
7.2.1 Availability of relevant documents 相关文件的有效性
7.2.1.1 Relevant documentation should be available at each stage of manufacturing operations
相关文件在每个生产操作中是可行的
7.2.1.2 Manufacturing operations should be carried out according to manufacturing documentation,including:
根据相关文件进行下列操作：
a) suitable equipment;适合的设备
b) formula for the product;产品配方
c) list of all raw materials identified according to relevant documents indicating batch numbers and quantities;
根据相关文件指示的批号和数量，经确定的原料清单。
d) detailed manufacturing operations for each stage, such as addition of raw materials, temperatures, speeds, mixing times,
sampling, cleaning and, if necessary, sanitizing of equipment, and bulk product transfer.
生产过程的各个细节，如原料的添加、温度控制、转速、混合时间、抽样、清洗、必要时消毒设备、散装产品的转
移等。
7.2.2 Start-up checks 生产前的检查
Before starting any manufacturing operations, it should be ensured that:生产前要确保：
a) all documentation relevant to the manufacturing operations is available;所有相关文件要到位
b) all raw materials are available and released;所有原料是可使用的并被放行。
c) suitable equipment is available for use, in working order, cleaned and, if necessary, sanitized;设备可用并可以清洗和消
毒
d) clearance of the area has been performed to avoid mixing with materials from previous operations.上一个操作完毕后要
17对所在区域进行清洁以避免交叉污染
7.2.3 Assignment of a batch number 确定批号
A batch number should be assigned to each batch of manufactured bulk product. This number does not need to be identical
with the batch number that appears on the label of the finished product, but, if not, it should be easy to relate to that number.
应*散装产品的批号，虽然并不需要和成品上的批号相同，但应当与成品的批号相关联。
7.2.4 Identification of in-process operations 过程操作的确认
7.2.4.1 In accordance with the formula, all raw materials should be measured or weighed, into clean and suitable containers
labelled with appropriate identification or directly into the equipment used for manufacturing.
根据配方，所有的原料都应被计量或称量，投入于干净适合的有适当标识的容器里或者直接投在生产设备当中。
7.2.4.2 At all times, it should be possible to identify major equipment, containers of raw materials and containers of bulk
products.
在任何时候都需识别主要设备，盛原料和散装产品的容器。
7.2.4.3 Identification of containers of bulk products should indicate:盛散装产品的容器的标识：
a) name or identifying code;名称和识别码
b) batch number;批号
c) storage conditions when such information is critical to assure the quality of the product.当此信息对产品质量重要时标
识储存条件
7.2.5 In-process control 过程控制
7.2.5.1 In-process controls and their acceptance criteria should be defined.
过程控制及其可接受准则应确定
7.2.5.2 In-process controls should be performed according to a defined programme.
过程控制要按确定的程序进行
7.2.5.3 Any result outside the acceptance criteria should be reported and appropriately investigated.
要报告任何**出规定的结果并做分析
7.2.6 Bulk product storage 散装产品储存
7.2.6.1 Bulk product should be stored in suitable containers, in defined areas, and under appropriate conditions.
散装产品要储存在适合的容器内，特定的区域，适合的条件下。
7.2.6.2 The maximum bulk product storage duration should be defined.
设定散装产品ZUI大储存有效期
7.2.6.3 When this duration is reached, the bulk product should be re-evaluated before use.
当达到有效期时，使用前需对散装产品进行再评估
7.2.7 Re-stocking raw materials 原料再储存
If raw materials remain unused after weighing and are intended and deemed acceptable to return to stock, their containers
should be closed and properly identified.
称量后未用的剩下原料返还到仓库时要被标识，并且盛装的容器要被封口和标识。
7.3 Packaging operations 包装作业
7.3.1 Availability of documents 相关文件的有效性
7.3.1.1 Relevant documentation should be available at each stage of packaging operations.
相关文件在每个生产操作中是可获得
7.3.1.2 Packaging operations should be carried out according to packaging documentation including:
18根据相关文件进行操作，这些文件应包括：
a) suitable equipment;适合的设备
b) list of packaging materials defined for the intended finished product;用于包装成品的所有包材清单
c) detailed packaging operations such as filling, closing, labelling, and coding.详细的包装操作：诸如填充，封箱，标识
和喷码。
7.3.2 Start-up checks 生产之前的检查
Before starting any packaging operation, it should be ensured that:在开始包装前要确保：
a) the area has been cleared of materials to avoid mixing with materials from previous operations; 上一个操作完毕后要对
所在区域进行清线以避免混用。
b) all documentation relevant to the packaging operations, is available;有关包装的相关文件是可获得
c) all packaging materials are available;所有包装材料到位
d) suitable equipment is available for use, in working order, cleaned and, if necessary, sanitized;使用了适合的设备，对要
用到的设备进行清洗必要时进行了消毒
e) any coding to permit identification of the product is defined.要确定任何产品的识别码无误。
7.3.3 Assignment of batch number 批号的确定
7.3.3.1 A batch number should be assigned to each unit of finished product.每组成品的批号要被确定
7.3.3.2 This number does not need to be identical with the batch number that appears on the label of the bulk product, but, if
not, it should be easy to relate to that number. 每个产品要有批号，虽然并不需要和散装产品上的批号相同，但应
当与散装产品的批号相关联。
7.3.4 Packaging line identification 包装生产线识别
At all times, it should be possible to identify the packaging line with its name or identifying code, the name or identifying
code of the finished product and the batch number.
在任何时候，可通过包装生产线的名称或识别码，成品名称、识别码或批号。
7.3.5 Checks of on-line control equipment 在XIAN监KONG设备的检查
If used, on-line control equipment should be regularly checked according to a defined programme.如果使用这样的设备，
应根据相关文件对这些设备进行定期检查
7.3.6 In-process control 过程控制
7.3.6.1 In-process controls and their acceptance criteria should be defined.制定过程控制的可接受准则
7.3.6.2 In-process controls should be performed according to a defined programme.
过程控制要按确定的程序进行
7.3.6.3 Any result that is outside the acceptance criteria should be reported and appropriately investigated.
报告**出准则的结果并分析
7.3.7 Re-stocking of packaging materials 包材再储存
If packaging materials remain unused after packaging operations and are intended and deemed acceptable to return to stock,
their containers should be closed and properly identified.
包装剩下的包材返还到仓库时要被标识，并且盛装的容器要被封口和标识。
7.3.8 Identification and handling of work-in-process 在制品的标识和处理
Filling and labelling is usually a continuous process. Where this is not the case, special measures including segregation and
identification should be applied so that no mix-ups or mislabelling can occur.
填充和贴标通常是一个连续的过程。如果不是，应使用特定的措施诸如阻隔和标识，以避免混贴和漏贴