GMP 車間規(guī)劃
2013/6/4 7:02:56
GMP 車間規(guī)劃
GMP 車間規(guī)劃
詳細介紹
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)指從負責指導藥品生產質量控制的人員和生產操作者的素質到生產廠房，設施，建筑，設備，倉儲，生產過程，質量管理，工藝衛(wèi)生，包裝材料與標簽，直至成品的貯存與銷售的一整套保證藥品質量的管理體系。
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 的基點是為了要保證藥品質量，必須做到防止生產中藥品的混批，混雜污染和交叉污染，以確保藥品的質量。
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基本內容涉及到人員，廠房，設備，衛(wèi)生條件，起始原料，生產操作，包裝和貼簽，質量控制系統(tǒng)，自我檢查，銷售記表，用戶意見和不良反應報告等方面。在硬件方面要有符合的環(huán)境，廠房，設備；在軟件方面要有可靠的生產工藝，嚴格的管理制度，完善的驗證系統(tǒng)。
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車間要求以工藝為主導，并在其它專業(yè)如總圖，土建，設備，安裝，電力，暖通，外管等密切配合下完成工藝布置：
生產區(qū)應有足夠的平面和空間，要有足夠的地方合理安放設備和材料，防止不同藥品的中間體之間發(fā)生混雜，防止由其它藥品或其它物質帶來的交叉污染；
①Storage of raw materials to be detected，Semi finished products area. ①存放待檢原料，半成品面積。
②Intermediate laboratory area ②中間體化驗室面積 ③Equipment cleaning area ③設備清洗面積
④Cleaning tool room area ④清潔工具間面積 ⑤The processing of raw materials, processing area. ⑤原輔料的加工，處理面積。
⑥Stored pending unqualified raw materials, semi-finished products of the area, in order to avoid error operation.
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。
2.Appropriate measures to ensure that there are different operating not in the same area at the same time
有相應措施來保證不同操作不在同一區(qū)域同時進行；
3.Cleanliness level of interconnectedness between different rooms have antifouling measures
相互聯系的潔凈級別不同的房間之間要有防污措施；
4.In the layout should be compatible with the cleanliness level of purification facilities and rooms;
在布置上要有與潔凈級別相適應的凈化設施與房間；
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;
原輔料，半成品和成品以及包裝材料的存貯區(qū)域應明顯，待檢品，合格品和不合格品應有足夠區(qū)域存放并嚴格分開，存放區(qū)與生產區(qū)的距離要盡量縮短；
6.Full workshop flow, logistics should be simple, reasonable, to avoid flow, logistics confounding;
全車間的人流，物流應簡單，合理，避免人流，物流混雜；
7.Different processes of production area best links at reasonable order process;
不同生產工序的生產區(qū)最好按工序先后次序合理連接；
8.Should be wide enough aisle, to mark the junction to prevent mixing drug injection;
應有足夠寬的過道，結合處注以標志以防混藥；
9.Should be sterile clothes washing（Especially in the production or packing penicillins）, drying room, and meet the requirements of the appropriate air cleaner;
應有無菌服裝（特別是生產或分裝青霉素類藥物）的洗滌，干燥室，并符合相應的空氣潔凈要求；
10. Should have equipment and containers with washing area.
應有設備及容器具洗滌區(qū)。
Process conditions are met, there is room cleanliness level requirements are arranged according to the following requirements:
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.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;
潔凈級別高的潔凈室（區(qū)）宜布置在人員最少到達的地方，并宜靠近空調機房；
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.The same level of air cleanliness should be relatively concentrated cleanroom;
空氣潔凈度等級相同的潔凈室（區(qū)）宜相對集中；
4.Personnel and materials between different cleanliness class room discrepancy should prevent the pollution measures, such as setting the locker room, buffer, transfer window;
不同空氣潔凈度等級房間之間人員及物料的出入應有防止污染措施，如設置更衣間，緩沖間，傳遞窗等；
5.Cleanroom air purification how recycling, should take effective measures to avoid contamination and Cross-contamination;
潔凈室（區(qū)）的凈化空氣如何循環(huán)使用，應采取有效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.
潔凈室（區(qū)）內安裝的水池，地漏不得對藥品產生污染；100級潔凈室（區(qū)）內不得設置地漏，操作人員不應祼手操作，妥不可避免時，手部應及時消毒；10000級潔凈室（區(qū)）使用的傳輸設備不得穿越較低級別區(qū)域；100000級以上區(qū)域的潔凈工作服應在潔凈室（區(qū)）內洗滌，干燥，整理，必要時應按要求滅菌。
