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.
7.2 Manufacturing operations 制造作业
7.2.1 Availability of relevant documents 相关文件的有效性
18.104.22.168 Relevant documentation should be available at each stage of manufacturing operations
22.214.171.124 Manufacturing operations should be carried out according to manufacturing documentation,including:
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;
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.
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
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
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.
7.2.4 Identification of in-process operations 过程操作的确认
126.96.36.199 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.
188.8.131.52 At all times, it should be possible to identify major equipment, containers of raw materials and containers of bulk
184.108.40.206 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
7.2.5 In-process control 过程控制
220.127.116.11 In-process controls and their acceptance criteria should be defined.
18.104.22.168 In-process controls should be performed according to a defined programme.
22.214.171.124 Any result outside the acceptance criteria should be reported and appropriately investigated.
7.2.6 Bulk product storage 散装产品储存
126.96.36.199 Bulk product should be stored in suitable containers, in defined areas, and under appropriate conditions.
188.8.131.52 The maximum bulk product storage duration should be defined.
184.108.40.206 When this duration is reached, the bulk product should be re-eva luated before use.
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.
7.3 Packaging operations 包装作业
7.3.1 Availability of documents 相关文件的有效性
220.127.116.11 Relevant documentation should be available at each stage of packaging operations.
18.104.22.168 Packaging operations should be carried out according to packaging documentation including:
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
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
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
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
22.214.171.124 A batch number should be assigned to each unit of finished product.每组成品的批号要被确定
126.96.36.199 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完全相同，但应
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.
7.3.5 Checks of on-line control equipment 在线监控设备的检查
If used, on-line control equipment should be regularly checked according to a defined programme.如果使用这样的设备，
7.3.6 In-process control 过程控制
188.8.131.52 In-process controls and their acceptance criteria should be defined.制定过程控制的可接受准则
184.108.40.206 In-process controls should be performed according to a defined programme.
220.127.116.11 Any result that is outside the acceptance criteria should be reported and appropriately investigated.
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.
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.