• 详细介绍

"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,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。

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.


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 .


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.


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


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


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


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;


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


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


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


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


10. Should have equipment and containers with washing area.


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


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;


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


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


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


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


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.     


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