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GMP 车间规划

GMP 车间规划

2020-02-06    

 GMP—(Good Manufacturing Practice for Drug) refers to the responsible for the quality control of pharmaceutical production personnel and production operator's quality to the production workshop, facilities, buildings, equipment, storage, production process, quality management, technology and health, packing materials and labels, until the finished product storage and sale of a complete set of management system which is to ensure the quality of medicines.

GMP--(Good  Manufacturing  Practices for Drug)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,直至成品的贮存与销售的一整套保证药品质量的管理体系。

The base of GMP is to ensure drug quality, must be to prevent the production of medicines mixed batch, mixed contamination and cross-contamination, in order to ensure the quality of the drug.

GMP 的基点是为了要保证药品质量,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。

Basic content of GMP involves the personnel, plant, equipment, sanitary conditions, the starting materials, the production operation, the packing and label, quality control system, self-examination, sales records, user opinions and adverse reactions report, etc. To be met in terms of hardware environment,it needs to have plant and equipment; On software, it need to have reliable production technology, strict management system and perfecting  validation system.

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,包装和贴签,质量控制系统,自我检查,销售记表,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生产工艺,严格的管理制度,完善的验证系统。

The GMP workshop requires to regard the technology as the leading factor, and completed the projecet with the help of other professions such as general layout, civil engineering, installation, electrical, hvac, close coordination with the outer tube and so on .

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


1.Production area should have enough plane and space,and need to have enough space put equipment and materials reasonablely,to prevent mixing among different drugs and cross contamination from other drugs or other substances.

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和材料,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它物质带来的交叉污染;

①Storage of raw materials to be detected,Semi finished products area.     ①存放待检原料,半成品面积。  

②Intermediate laboratory area          ②中间体化验室面积     ③Equipment cleaning area     ③设备清洗面积

④Cleaning tool room area     ④清洁工具间面积     ⑤The processing of raw materials, processing area.    ⑤原辅料的加工,处理面积。

⑥Stored pending unqualified raw materials, semi-finished products of the area, in order to avoid error operation.     

⑥存放待处理的不合格的原材料,半成品的面积,以免错误投产。


2.Appropriate measures to ensure that there are different operating not in the same area at the same time

有相应措施来保证不同操作不在同一区域同时进行;


3.Cleanliness level of interconnectedness between different rooms have antifouling measures

相互联系的洁净级别不同的房间之间要有防污措施;


4.In the layout should be compatible with the cleanliness level of purification facilities and rooms;

在布置上要有与洁净级别相适应的净化设施与房间;


5.Raw materials, semi-finished and finished products and packaging materials storage area should be clear, to be seized products, qualified and unqualified products should have sufficient storage area and strictly separated, storage areas and production areas to try to shorten the distance;

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,存放区与生产区的距离要尽量缩短;


6.Full workshop flow, logistics should be simple, reasonable, to avoid flow, logistics confounding;

全车间的人流,物流应简单,合理,避免人流,物流混杂;


7.Different processes of production area best links at reasonable order process;

不同生产工序的生产区按工序先后次序合理连接;


8.Should be wide enough aisle, to mark the junction to prevent mixing drug injection;

应有足够宽的过道,结合处注以标志以防混药;


9.Should be sterile clothes washing(Especially in the production or packing penicillins), drying room, and meet the requirements of the appropriate air cleaner;

应有无菌服装(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;


10. Should have equipment and containers with washing area.

应有设备及容器具洗涤区。


Process conditions are met, there is room cleanliness level requirements are arranged according to the following requirements:

在满足工艺条件的前提下,有洁净级别要求的房间按下列要求布置:

1.High level of cleanliness of the clean room(area) should be arranged in person at least reach the place, and should be close to the air conditioning room;

洁净级别高的洁净室(区)宜布置在人员少到达的地方,并宜靠近空调机房;

2.Different levels of clean room(area) cleanliness cleanliness level should be at the level from the inside and the outside layout;

不同洁净度等级的洁净室(区)宜按洁净度等级的高低由里及外布置;

3.The same level of air cleanliness should be relatively concentrated cleanroom;

空气洁净度等级相同的洁净室(区)宜相对集中;

4.Personnel and materials between different cleanliness class room discrepancy should prevent the pollution measures, such as setting the locker room, buffer, transfer window;

不同空气洁净度等级房间之间人员及物料的出入应有防止污染措施,如设置更衣间,缓冲间,传递窗等;

5.Cleanroom air purification how recycling, should take effective measures to avoid contamination and Cross-contamination;

洁净室(区)的净化空气如何循环使用,应采取措施避免污染和交叉污染;

6.Tank installation of clean room(area),The floor drain to be on the drugs produce pollution;100 clean room must not be set to drain,Operation should not bare-handed operation, unavoidable, hands should be disinfected.10000 clean room used transmission equipment shall not pass through lower-level zones;100,000 or more regions in the clean room clean clothes should be washed, dried, organize, when necessary, should be required to disinfection.     

洁净室(区)内安装的水池,地漏不得对药品产生污染;100级洁净室(区)内不得设置地漏,操作人员不应祼手操作,妥不可避免时,手部应及时消毒;10000级洁净室(区)使用的传输设备不得穿越较低级别区域;100000级以上区域的洁净工作服应在洁净室(区)内洗涤,干燥,整理,必要时应按要求灭菌。


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