• A unique batch manufacturing reco

• A unique batch manufacturing record (BMR) should be generated for each batch or lot manufactured
• The batch number to be printed on the bottom of the device, clearomiser, atomiser and packaging will need to be recorded on the BMR
• A BMR should contain; the unique batch number or job number for the work order, the date the activity is completed on, the total final production quantity and the identity of the product and/or any related code
• The BMR should include a bill of materials (BOM) listing all of the components required for the product. The BOM should describe each component by name and code number reference, the quantity required and the requirement for overage (if necessary)
• The BMR should be completed to record the suppliers lot for each component used
• The BMR should list all steps in the assembly and testing operation in a sequential order related to the order of assembly. Any steps requiring specialist personal protective equipment (PPE), caution or specialist activity should be highlighted
• Provision should be made within the BMR to record any critical measurements or recordings and confirmation of the completion of each step or stage in the process
• The BMR should include reconciliation of the components or sub-assemblies issued to line and used in the process, discarded as reject or removed for testing (if not returned to line)
• Re-work activities should be performed in accordance with written procedures included with the batch record. Reconciliation of re-work assemblies should be included within the respective BMR
• Critical assembly or measurement equipment should be listed on the BMR and the use of this equipment referenced on the BMR to permit traceability
• A final reconciliation of total finished product produced should be included against agreed acceptance criteria and any discrepancy suitably investigated and recorded
• All deviations from the documented process should be recorded, separately and cross referenced on the relevant BMR

結果 (中文) 3:

•独特的批生产记录（BMR）应当对每一批生产的
•印在纸上的设备，底部clearomiser批号生成，雾化器和包装需要记录在BMR
•BMR应包含；独特的批号或工号的工作秩序，活动完成日期，最后的总生产量和产品和/或任何相关的代码
•BMR应包括账单的身份材料（BOM）列出所有的产品所需的部件。BOM的名称和编号参考描述每个组件，所需数量和范围的要求（如有必要）
•BMR应完成为每个组件使用
•BMR应列出所有步骤在装配和测试运行在一个装配顺序相关的供应商很多记录的顺序。任何需要专家的个人防护装备（PPE），谨慎的步骤或专业活动要突出
•规定应在BMR记录任何关键测量或记录和每个步骤或阶段完成确认过程中
•BMR应包括的组件或子组件发出的线和使用的过程中的和解，而拒绝或删除测试（如果不是回到线）
应按照批记录的书面程序进行重新工作活动。重新组装和解工作应包括各自的BMR
•临界装置或测量设备应在BMR和使用这一设备的引用在BMR允许追溯
上市•最终和解总成品生产应包括根据商定的验收标准和不适当的调查和记录
•从记载的过程进行记录，分别对相关
BMR
交叉引用