GMP Brief Introduction:
GMP standard (pharmaceutical production quality management standard) is to guarantee the quality of drugs in the continuous production system. It makes the danger of not qualified under the pharmaceutical production process to be reduced to a minimum. The GMP contains all aspects requirements , from factories to the ground, equipment, personnel and training, health, water and air purification, the production and documents."GMP" is the abbreviation of Good Manufacturing Practice, Chinese meaning is "Good practices", or "Good Manufacturing standard", is a kind of autonomy management system which pay special attention to the quality and health safety of product.
GMP standard is a set of mandatory standards applicable to the pharmaceutical, food industries, requiring companies from raw materials, personnel, facilities, equipment, production process, packaging, transportation, quality control, etc aspects must according to the relevant regulations of the state health quality requirements, formed a set of operational code of conduct to help enterprises to improve health environment, discover the problems existing in the production process, to improve them. In short, GMP production enterprises should have a good production equipment, reasonable production process, strict quality management and perfect detection system, to ensure the quality of the final product (including food safety and hygiene) conform to the regulations.
Our Advantages:
Biopharmaceutical companies require GMP's goal is to make sure to establish scientific, strict aseptic pharmaceutical production environment, process, operation and management system, to eliminate all possible, the potential biological activity, dust, pyrogen contamination, produce the high quality, health and safety of drug products. What we call the biopharmaceutical purification engineering-GMP clean workshop engineering solutions and pollution control technology is one of the main means to assure the GMP successfully;
Through in-depth study of biopharmaceutical customer production environment and engineering experience, we know the key to biological pharmaceutical production environment control; Energy-saving is our priority focus system plan; We do best for our customers to meet GMP, Fed 209,ISO14644, IEST, EN1822 international standard requirements, and application of the latest energy saving technology of environmental solutions; We can provide from the GMP whole plant planning and design, clean air conditioning system, purify logistics solution, clean decorative system; Energy-saving reconstruct, water and electricity, ultra pure gas pipeline, clean room monitoring, maintenance system of comprehensive installation of supporting services.
The whole workshop Class 10000 purification, ground uses epoxy floor processing |
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Inspection personnel are using special clean room equipment to test and make records carefully |
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Class 100 Clean Room |
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Clean corridor using electronic interlocking to achieve two-door buffer, install the new type HEPA air supply outlet at the top to ensure cleanliness |
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Internal environment and details |
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Construction photos at abroad |
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