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.
应指定散装产品的批号，虽然并不需要和成品上的批号完全相同，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.
要报告任何超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.设定散装产品最大储存有效期
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 id