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GMP车间

GMP车间

  • 所属分类:医学检验
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  • 发布时间:2022-03-16 16:36:36
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GMP车间规划

GMP Workshop Planning

GMP指从负责指导药品生产质量控制的人员和生产操作者的素质到生产厂房,设施,建筑,设备,仓储,生产过程,质量管理,工艺卫生,包装材料与标签,直至成品的贮存于销售的一整套保证药品质量的管理体系。

GMP refers to the quality of the personnel and operators in charge of the quality control of drug production, to the production plant, facilities, construction, equipment, storage, production process, quality control, process hygiene, packaging materials and labels, until the storage of finished products in the sale of a complete set of guarantee drug quality management system.

GMP的基点是为了要保证药品质量,必须做到防止生产中药品的混批,混杂污染和交叉污染,以确保药品的质量。

The basis of GMP is to ensure the quality of drugs, it is necessary to prevent mixed batch, mixed contamination and cross-contamination in order to ensure the quality of drugs.

GMP基本内容涉及到人员,厂房,设备,卫生条件,起始原料,生产操作,包装和标签,质量控制系统,自我检查,销售记录,用户意见和不良反应报告等方面。在硬件方面要有符合的环境,厂房,设备;在软件方面要有可靠的成产工艺,严格的管理制度,完善的验证系统。

GMP basic content involves personnel, plant, equipment, sanitary conditions, starting materials, production operations, packaging and labelling, quality control system, self-inspection, sales records, user feedback and adverse reports. In terms of hardware, there should be a consistent environment, plant, equipment; in terms of software, there should be a reliable production process, strict management system, improve the verification system.

GMP车间要求以工艺为主导,并在其他专业如总图,土建,设备,安装,电力,暖通,外管等密切配合下完成工艺布置。

GMP Workshop requires process-oriented, and in other professional such as general plan, civil engineering, equipment, installation, power, heating, pipe and other close cooperation to complete the process layout.

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生产区应有足够的平面和空间,要有足够的地方合理安放设备的材料,防止不同药品的中间体之间发生混杂,防止由其它药品或其他物质带来的交叉污染

The production area should have sufficient plane and space, sufficient space for the proper placement of equipment materials, to prevent the intermingling of intermediates of different drugs and to prevent cross-contamination by other drugs or other substances

有相应措施来保证不同操作不在同一区域同时进行

Measures are taken to ensure that different operations are not carried out in the same area at the same time

相互联系的洁净级别不同的房间之间要有防污措施

Inter-connected clean level between different rooms to have anti-pollution measures

在布置上要有洁净级别相适应的净化设施与房间

In the layout should have the clean level suitable purification facilities and the room

原辅料,半成品和成品以及包装材料的存贮区域应明显,待检品,合格品和不合格品应有足够区域存放并严格分开,存放区于生产区的距离要尽量缩短

Storage areas for raw materials, semi-finished products and finished products, and packaging materials should be visible. Sufficient areas should be kept separate and strictly separated for the goods to be inspected, the qualified products and the non-qualified products

全车间的人流、物流应简单,合理,避免混杂

The flow of people in the workshop, logistics should be simple, reasonable, to avoid confusion

不同生产工序的生产区最好按工序先后次序合理连接

The production area of different production process had better connect with each other in a reasonable order

有足够宽的过道,综合处注以标志以防混药

With wide enough aisles and comprehensive marking to prevent mixing

有无菌服装(特别是生产或分装青霉素类药物)的洗涤,干燥室,并符合相应的空气洁净要求

Have Sterile clothing (especially the production or distribution of penicillin drugs) washing, drying room, and meet the corresponding air clean requirements

有设备及容器洗涤区

There is equipment and container washing area

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