指從負(fù)責(zé)指導(dǎo)藥品生產(chǎn)質(zhì)量控制的人員和生產(chǎn)操作者的素質(zhì)到生產(chǎn)廠房，設(shè)施，建筑，設(shè)備，倉儲，生產(chǎn)過程，質(zhì)量管理，工藝衛(wèi)生，包裝材料與標(biāo)簽，直至成品的貯存與銷售的一整套保證藥品質(zhì)量的管理體系。
GMP的基點是為了要保證藥品質(zhì)量， 必須做到防止生產(chǎn)中藥品的混批，混雜污染和交叉污染，以確保藥品的質(zhì)量。
GMP基本內(nèi)容涉及到人員，廠房，設(shè)備，衛(wèi)生條件，起始原料，生產(chǎn)操作，包裝和貼簽，質(zhì)量控制系統(tǒng)，自我檢查，銷售記表，用戶意見和不良反應(yīng)報告等方面。在硬件方面要有符合的環(huán)境，廠房，設(shè)備;在軟件方面要有可靠的生產(chǎn)工藝，嚴(yán)格的管理制度，完善的驗證系統(tǒng)。
GMP車間要求以工藝為主導(dǎo)，并在其它專業(yè)如總圖，土建，設(shè)備，安裝，電力，暖通，外管等密切配合下完成工藝布置：

1、生產(chǎn)區(qū)應(yīng)有足夠的平面和空間，要有足夠的地方合理安放設(shè)備和材料，防止不同藥品的中間體之間發(fā)生混雜，防止由其他藥品或其它物質(zhì)帶來的交叉污染;
① 存放待檢原料，半成品面積;
② 中間體化驗室面積;
③ 設(shè)備清洗面積;
④ 清潔工具間面積;
⑤ 原輔料的加工，處理面積;
⑥ 存放待處理的不合格的原材料，半成品的面積，以免錯誤投產(chǎn)。
2、有相應(yīng)措施來保證不同操作不在同一區(qū)域同時進(jìn)行;
3、相互聯(lián)系的潔凈級別不同的房間之間要有防污措施;
4、在布置上要有與潔凈級別相適應(yīng)的凈化設(shè)施與房間;
5、原輔料，半成品和成品以及包裝材料的存貯區(qū)域應(yīng)明顯，待檢品，合格品和不合格品應(yīng)I并嚴(yán)格分開，存放區(qū)與生產(chǎn)區(qū)的距離要盡量縮短;
6、全車間的人流，物流應(yīng)簡單，合理，避免人流，物流混雜;
7、不同生產(chǎn)工序的生產(chǎn)區(qū)最好按工序先后次序合理連接;
8、應(yīng)有足夠?qū)挼倪^道，結(jié)合處注以標(biāo)志以;
9、應(yīng)有無菌服裝(特別是生產(chǎn)或分裝青霉素類藥物)的洗滌，干燥室，并符合相應(yīng)的空氣潔凈要求;
10、應(yīng)有設(shè)備及容器具洗滌區(qū)。

在滿足工藝條件的前提下，有潔凈級別要求的房間按下列要求布置：
1、潔凈級別高的潔凈室(區(qū))宜布置在人員最少到達(dá)的地方，并宜靠近空調(diào)機(jī)房;
2、不同潔凈度等級的潔凈室(區(qū))宜按潔凈度等級的高低由里及外布置;
3、空氣潔凈度等級相同的潔凈室(區(qū))宜相對集中;
4、不同空氣潔凈度等級房間之間人員及物料的出入應(yīng)有防止污染措施，如設(shè)置更衣間，緩沖間，傳遞窗等;
5、潔凈室(區(qū))的凈化空氣如何循環(huán)使用，應(yīng)采取有效措施避免污染和交叉污染;
6、潔凈室(區(qū))內(nèi)安裝的水池，地漏不得對藥品產(chǎn)生污染;100級潔凈室(區(qū))內(nèi)不得設(shè)置地漏，操
作人員不應(yīng)裸手操作，不可避免時，手部應(yīng)及時消毒;10000級潔凈室(區(qū))使用的傳輸設(shè)備不得穿越較低級別區(qū)域;100000級以上區(qū)域的潔凈工作服應(yīng)在潔凈室(區(qū))內(nèi)洗滌，干燥，整理，必要時應(yīng)按要求滅菌;

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;