TCHIBO验厂咨询-智宝GMP产品质量责任与原材料隔离存放及生产设备校准要求

 

 

1、Name of the cosmetic item (Article-Nr.) 化妆品名称(货号)

2、List of hardware equipment for production生产设备清单

3、Component list and quantity成分列表及其含量

4、Manufacturing details生产方法及过程

5、List of inline inspection产中验货记录

1、Product name (Article-Nr.), quantity and lot-Nr. 产品名称(货号)，数量和批号

2、Production date生产日期

3、Lot-Nr. or incoming QC record  of raw-material批号或原材料的验货记录

4、Detail manufacturing process incl. list of machinery involved for this process详细的生产过程，包括所使用的设备明细

5、Qc records ( incl. signature & name of inspector, date) 质检验货记录（有质检人员姓名签字和日期）

6、Supervisor name & signature, date on all records所有记录须有监督人员姓名，签字和日期。

 

1、Product name (Article-Nr.), sample-quantity, date of inspection and lot Nr. 产品名称(货号)，样品数量，验货日期和批号

2、It must be marked from where the sample is taken from 须标明样品从哪里取得

3、Result 结果

4、Decision, signature and date 结论，签名和日期

 

 

1、1 year must be available 存档期至少一年

2、all documentations of each production lot 每批次都有生产记录

3、reference samples ( stored under the same conditions as specified on the merchandise) 留样 （存放于产品说明中规定的储存条件）

 

1、Production must be done with well trained stuff  under experienced supervision acc. manufacturing specifications 生产须按照生产规范由经过培训的员工在有经验的管理人员监督下完成

2、Before production start all equipment must be clean 在开始生产前所有机器设备应清理干净。

3、Mix up of lot numbers must be avoided therefore clear marking of all containers with lot-Nr.所有容器必须有清楚的批号标识以避免不同批次的产品发生混淆。

4、Production process with dust needs proper ventilation 带尘生产需有适当通风。

5、Process parameter must be maintained during the whole production including documentation 所有生产数据在整个生产过程和记录中要保持一致

 

1、A written hygiene program must be available 须有书面的卫生操作规定

2、Uniform, head protection and gloves 工人须穿工作服，佩戴头部保护用品和手套

3、Hand washing after each meal and toilet，饭后及厕后必须洗手

4、Cleaning – and disinfections plan ( how to do the        disinfect ion, how often and  who is responsible) 清洗和消毒计划（怎样消毒，实施周期和负责人）

5、Disposal of material acc. Environmental requirements 依据环保要求处置物料

1、written procedure how to handle incoming raw material 关于如何处理进来的原材料的书面程序

2、incoming material must comply with written specifications 进料必须与书面规格要求相符。

3、marking of containers with material descriptions, lot-nr. and quantity 所盛放容器必须标明物料说明，批号和数量

4、clean storage environment 仓储环境要干净

5、raw material must not have a chemical reaction with packing material 原材料和盛放的容器材料一定不能产生化学反应。

6、incoming QC sample test 进料样品须做测试

7、released and rejected raw material marked accordingly and stored separately 合格或退货的原材料须标识清楚并分开存放

/8、tape water for production must be tested regular (microbiological tests) as well as test results recorded 生产用自来水的必须做常规测试（微生物测试）并记录测试结果

 

1、washing facilities and locker rooms must be inside of the production building设备清理和更衣室必须和生产在同一建筑内。

2、production outlets must be clean, free of insects and dust 生产车间必须干净，无虫无灰

3、production outlets must be isolated from outside 生产车间须和外面隔离

4、production facilities have a tile floor and the wall is free of cracks or peeling off paint 厂房需有瓷砖地面，墙面不能有裂缝或破落的油漆

5、ventilation and  air-conditioning should not have a negative impact of the production 通风设施和空调不能对生产产生不良影响

6、inside of the production outlets must be a system implemented to avoid mix-up of components 生产车间的内部须有有效地措施避免混淆各种成分

7、storage outlets must be clean and big enough  to avoid mix-up of raw-material or final products 仓库须干净，有足够空间，以避免混放原材料或者成品

8、separate storage of rejected and released material 不合格的物料与合格物料必须分开存放

9、separate storage facilities for inflammable or water contamination material 易燃或可造成水污染的物质须单独存放

1、equipment must be resistant against  disinfections and cleaning material 设备需对消毒和清洗物质没有反应

2、equipment must be designed to avoid decontamination of cosmetic products 设备应不能对化妆品产生污染

3、set up of equipment must be done in such a way that a secure production in sequence will be done 设备的摆放应保证安全生产。

4、equipment must be easily to clean ( no left over) 设备必须易于清理，无残留

5、after each production the equipment must be 100% cleaned ( disinfections and sterilization of machine parts which have contact with the cosmetic material 每次生产结束后，设备必须100%清洗。（对与化妆品材料接触的部分进行消毒和杀菌）

6、calibration of scale- and measuring equipment 称和称量设备要定期校对

 

1、Management with engineering/chemical background is required  要求有工程或者化学学历背景的管理人员

2、Management and supervisor organization set up 建立管理监督机制

3、Training program 培训机制

4、No staff must be employed with transmitted disease 不能聘用携带传染病的员工

5、Uniform is required 要求穿工作服