GMP车间实验室规划
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。
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。
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。
GMP车间要求以工艺为主导，并在其它专业如总图，土建，设备，安装，电力，暖通，外管等密切配合下完成工艺布置：
1、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，防止由其他药品或其它物质带来的交叉污染;
① 存放待检原料，半成品面积;
② 中间体化验室面积;
③ 设备清洗面积;
④ 清洁工具间面积;
⑤ 原辅料的加工，处理面积;
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、有相应措施来保证不同操作不在同一区域同时进行;
3、相互联系的洁净级别不同的房间之间要有防污措施;
4、在布置上要有与洁净级别相适应的净化设施与房间;
5、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I并严格分开，存放区与生产区的距离要尽量缩短;
6、全车间的人流，物流应简单，合理，避免人流，物流混杂;
7、不同生产工序的生产区最好按工序先后次序合理连接;
8、应有足够宽的过道，结合处注以标志以;
9、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、应有设备及容器具洗涤区。
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、洁净级别高的洁净室(区)宜布置在人员最少到达的地方，并宜靠近空调机房;
2、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、空气洁净度等级相同的洁净室(区)宜相对集中;
4、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、洁净室(区)的净化空气如何循环使用，应采取有效措施避免污染和交叉污染;
6、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
作人员不应裸手操作，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;
GMP Workshop Planning refers to the quality of the personnel and operators in charge of quality control of drug production, to production plants, facilities, buildings, equipment, storage, production process, quality management, process hygiene, packaging materials and labels Until the storage and sale of finished products to ensure the quality of a complete set of drug management system. The basis of GMP is to ensure the quality of drugs, it is necessary to prevent mixed batch, mixed pollution and cross-pollution in order to ensure the quality of drugs. The basic content of GMP involves personnel, plant, equipment, sanitary conditions, starting materials, production operations, packaging and labeling, quality control system, self-inspection, sales records, user feedback and adverse reports. In terms of hardware, there should be consistent with the environment, plant, equipment; in terms of software, there should be reliable production process, strict management system, improve the verification system. 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: 1, production area should have enough plane and space, adequate space should be provided for proper storage of equipment and materials to prevent the mixing of intermediates of different drugs and to prevent cross-contamination by other drugs or other substances 2 Area of Intermediate Laboratory; 3 area of equipment cleaning; 4 area of Cleaning Tool Room; 5 area of processing of raw and auxiliary materials and processing; 6 area of storing unqualified raw materials to be processed and semi-finished products In case it goes into production. 2, there are corresponding measures to ensure that different operations are not carried out in the same area at the same time; 3, the inter-connected clean level between the different rooms to have anti-pollution measures; The storage area of raw materials, auxiliary materials, semi-finished products and finished products, and packaging materials should be obvious, the products to be inspected Qualified goods and unqualified goods should I and strictly separate, storage area and production area distance should be as short as possible; 6, the flow of people in the workshop, logistics should be simple, reasonable, avoid flow, logistics, Hybrid; 7. The production area of different production process should be connected reasonably according to the sequence of the production process. 8. There should be enough wide passageway to mark the combination; Aseptic clothing, especially the production or distribution of penicillin drugs washing, drying room, and meet the corresponding air cleaning requirements; 10, there should be equipment and container washing area. On the premise of satisfying the technological conditions, the rooms with clean level should be arranged according to the following requirements: 1. The clean room area with high clean level should be arranged in the place with least personnel, and should be close to the air-conditioning room; 2, the clean room area of different clean degree grade should be arranged from the inside to the outside according to the level of clean degree grade; 3, the Clean Room area of the same clean degree grade should be relatively concentrated; 4, different levels of air cleanliness between the room personnel and materials should be to prevent pollution measures, such as the setting of changing rooms, buffer rooms, transfer windows, etc. . 5, the clean room area of how to recycle clean air Effective measures should be taken to avoid pollution and cross-contamination; 6. Floor drains installed in the clean room area should not pollute the medicine; floor drains should not be installed in the clean room area of grade 100, and operators should not operate with bare hands When unavoidable, hands should be promptly disinfected; transmission equipment used in Class 10000 clean room area should not pass through lower class area; clean working clothes in Class 100000 and above area should be washed, dried, cleaned and sterilized if necessary;
