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What are the requirements for pharmaceutical production and quality management standards for equipment
time2013/03/20
(GMP norms) (Good Manufacturing Practice, GMP) the lowest drug production and quality management standards throughout all aspects of production of drugs in order to control the quality of products. GMP on equipment requirements:
1.Equipment design, selection, installation shall comply with the requirements of production, easy to clean, disinfected or sterilized, easy operation and maintenance, and maintenance. Prevent errors and reduce pollution.
2. Direct contact with the drugs equipment surfaces should be smooth, flat, easy cleaning or disinfection, corrosion resistance, chemical changes occur not with drugs or adsorption of drugs. The equipment used in lubricants, cooling, etc. may not be caused by drugs or container contamination.
3. The device fixed pipeline shall be marked with the name of the material of the tube, the flow of.
4. Preparation, storage and distribution of purified water, water for injection should be able to prevent microbial growth and contamination. The tank and the pipeline of the materials used should be non-toxic, corrosion resistant. The design and installation of the pipeline should avoid dead ends, blind tube. Storage tanks and pipelines require cleaning and sterilization cycles. Water for injection tank vent hydrophobic sterilizing filter should be installed not shed fibers. The storage of the water for injection may be incubated at 80 ℃ above, and incubated at 65 ° C or more cycles or below 4 ℃ storage.
5. For the production and testing equipment, instrumentation, measuring, weighing, its scope and precision should be consistent with the production and inspection requirements, pass mark, and regularly check.
6.Production equipment status flag should be obvious, and regular maintenance, maintenance and validation. Equipment installation, maintenance, operation and maintenance shall not affect product quality. Substandard equipment if possible, should be moved out of the production area should be clearly marked, not move out before.
7. Production, testing equipment shall have the use, repair, maintenance records and expert management.
Pharmaceutical production and quality and safety is everyone's responsibility, Jinan Dongtai filling machine equipment company to remind the general public should be mutual supervision!
1.Equipment design, selection, installation shall comply with the requirements of production, easy to clean, disinfected or sterilized, easy operation and maintenance, and maintenance. Prevent errors and reduce pollution.
2. Direct contact with the drugs equipment surfaces should be smooth, flat, easy cleaning or disinfection, corrosion resistance, chemical changes occur not with drugs or adsorption of drugs. The equipment used in lubricants, cooling, etc. may not be caused by drugs or container contamination.
3. The device fixed pipeline shall be marked with the name of the material of the tube, the flow of.
4. Preparation, storage and distribution of purified water, water for injection should be able to prevent microbial growth and contamination. The tank and the pipeline of the materials used should be non-toxic, corrosion resistant. The design and installation of the pipeline should avoid dead ends, blind tube. Storage tanks and pipelines require cleaning and sterilization cycles. Water for injection tank vent hydrophobic sterilizing filter should be installed not shed fibers. The storage of the water for injection may be incubated at 80 ℃ above, and incubated at 65 ° C or more cycles or below 4 ℃ storage.
5. For the production and testing equipment, instrumentation, measuring, weighing, its scope and precision should be consistent with the production and inspection requirements, pass mark, and regularly check.
6.Production equipment status flag should be obvious, and regular maintenance, maintenance and validation. Equipment installation, maintenance, operation and maintenance shall not affect product quality. Substandard equipment if possible, should be moved out of the production area should be clearly marked, not move out before.
7. Production, testing equipment shall have the use, repair, maintenance records and expert management.
Pharmaceutical production and quality and safety is everyone's responsibility, Jinan Dongtai filling machine equipment company to remind the general public should be mutual supervision!