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    Home > Active Ingredient News > Drugs Articles > Under the pressure of environmental protection, pharmaceutical enterprises are faced with "internal worries" and "external troubles"

    Under the pressure of environmental protection, pharmaceutical enterprises are faced with "internal worries" and "external troubles"

    • Last Update: 2019-05-15
    • Source: Internet
    • Author: User
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    [pharmaceutical Station market analysis] "internal worries", in the context of frequent environmental protection policies and regulatory policies of pharmaceutical enterprises, pharmaceutical enterprises need to face the problems of punishment due to environmental violations, illegal drug advertising and unqualified drug quality For example, under the high pressure of energy conservation and environmental protection, pharmaceutical enterprises listed as heavy pollution field must deal with the pollutants necessary to meet the standards before discharging Among them, pharmaceutical wastewater is one of the industrial wastewater which is difficult to be treated because of its complex composition, many kinds of organic pollutants, high concentration, and containing refractory biodegradation and toxic substances How to deal with pharmaceutical wastewater and make it discharge up to the standard is a difficult problem that pharmaceutical enterprises must think about and solve The treatment process and cost involved in it bring great pressure to pharmaceutical enterprises In terms of drug regulation, in 2018, the SFDA paid more and more attention to the supervision and inspection of the whole life cycle and the whole process, especially the supervision during and after the event According to data statistics, in 2018, the Drug Administration issued 36 notices on Revision of drug instructions, involving more than 90 kinds of drugs, far higher than the frequency of previous years, which also shows that the safety risk control of drug use by the drug administration is significantly strengthened In 2019, the strength of drug supervision is still strengthened Under the level of supervision, pharmaceutical enterprises have to attach great importance to quality issues From process, production to circulation, every link must be attached great importance to For enterprises, the detection of these processes also needs a lot of energy and cost input For example, in order to ensure the control of drug quality and safety, many drug manufacturers are equipped with equipment, scales, measuring tools, instruments and meters with appropriate measuring range and accuracy and quality inspection and testing functions Through the use of these quality inspection and testing equipment, as well as combined with the experience of pharmaceutical people, pharmaceutical manufacturers can scientifically grasp the quality of drugs, predict risks and standardize production The introduction of these equipment is also a considerable expense In terms of "foreign invasion", as the guarantee of drug quality needs to be checked from the source, no mistakes are allowed in every step However, in terms of the current source of drug production, many suppliers of pharmaceutical enterprises have been rectified due to defects in the production environment, which has caused great hidden dangers to the quality problems of pharmaceutical enterprises For example, affected by environmental protection policies such as environmental taxes, many small and medium-sized API enterprises shut down or closed down due to unqualified environmental protection indicators In addition, the number of API manufacturers is already large Under the background of environmental protection, high pressure and limited approval, there are only two or three API manufacturers left Once encountering the factors such as production line transformation and cost increase, it is easy to cause API shortage and drug shortage For another example, many Chinese herbal medicine enterprises, due to the uneven supply quality of upstream Chinese herbal medicine, resulting in frequent product quality problems, flying inspection is difficult to meet the standards According to the industry, drug quality and safety is the "sword of Damocles" hanging on the top of every pharmaceutical enterprise We must start from every link to ensure the quality and safety of drugs At present, in order to ensure the quality and safety of drugs, many pharmaceutical companies set up their own API factories to ensure the normal production and quality stability There are also traditional Chinese medicine enterprises that choose to establish their own planting bases for traditional Chinese medicine, scientific management, standardized production, ensure the quality and safety of traditional Chinese medicine from the source, and improve consumers' trust in products.
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