"1 file per 2 days", 44 documents within 3 months! This is the result of the promotion of drug administration reforms by various departments since the issuance of the Opinions on Deepening the Reform of the Examination and Approval System and Encouraging Innovation in Pharmaceutical Medical Devices (hereinafter referred to as “Opinionsâ€). Such a magnificent reform has only one purpose, which is to promote the more standardized and innovative development of the pharmaceutical industry.
The industry pointed out that "this is a document competition, the pharmaceutical industry is facing a reshuffle, and the quality of China's pharmaceutical products will be improved. Under the bold prediction, in the next three years, pharmaceutical companies will be in full swing." A pharmaceutical industry person Also stated in 2016, “Conservatively, in the next few years, one-third of domestic pharmaceutical companies will be eliminated.†The pharmaceutical industry has set off a wave of reforms, and industrial upgrading is imperative. Pharmaceutical companies will not upgrade or transform. Be eliminated. In the face of the "crisis" already on the road, pharmaceutical companies not only need to produce quality and quantity, but also need to pay attention to the upgrading of pharmaceutical equipment.
Pharmaceutical companies are taking these three steps well, and the quality upgrade of pharmaceutical equipment is not a problem.
Safeguarding the use of the public and using good medicines to ensure the quality and safety of medicines is the inherent essence of the implementation of the Opinions. The author understands that among the 44 documents, there are policies related to drug supervision, the quality of listed drugs and the quality of original and auxiliary packages, which all remind drug companies to pay attention to the quality and safety of drugs. So, how do you upgrade the quality of your pharmaceutical equipment?
China's pharmaceutical equipment has been completely new compared with the situation decades ago. Although there are still some shortcomings compared with foreign equipment, it has been widely recognized in terms of quality. For the quality upgrade of pharmaceutical equipment, the first thing pharmaceutical companies need to do is to eliminate outdated equipment. Whether in production efficiency, energy saving or equipment design, personalized design, backward pharmaceutical equipment can not become mainstream.
For example, under the influence of the “Made in China 2025†intelligence and green, some pharmaceutical companies have already begun to reorganize their pharmaceutical equipment. The author understands that the problem of traditional Chinese medicine dust has been plagued by pharmaceutical companies. In order to change the situation of “explosive growth†and “noise†of Chinese medicine pretreatment, Beijing Tongrentang eliminated backward pharmaceutical equipment and introduced Chinese medicine developed by Beijing Changfeng Jinding. Automated dust-free dispensing system. It is reported that all the equipments of the system are sealed by pipes, and the production process is completely sealed, which can realize dust-free operation. It can prevent dust from leaking and prevent the materials from being polluted by the external environment and achieve the purpose of green production.
The next step in eliminating backward pharmaceutical equipment is to purchase new equipment. So, when choosing a new device, what problems should the pharmaceutical company need to pay attention to? Taking the mixer as an example, Chen Jun, the sales director of Ssangyong Group, said that with the improvement of China's pharmaceutical equipment production technology and the constraints of national policies, the quality of the mixers in the domestic market is actually similar. In this case, the details become pharmaceutical companies. The key factor in choosing a device.
Although the mixer is a large-scale equipment, in terms of quality production, Chen Jun believes that although the equipment is large, it still needs to use "embroidery" to produce. Therefore, when selecting a mixer, the pharmaceutical company can pay attention to the details and cannot have a dead angle of 90 degrees. All the containers, including the stirring parts, should be the I angle and the arc angle. Of course, it's not just a mixer, but the pharmaceutical company also needs to choose other products.
Knowing the key factors in choosing a device, the most important step is coming. Although the equipment that meets the requirements has been purchased, in actual operation, the pharmaceutical company also needs to pay attention to the standard use of the equipment. For the production of sterile drugs, the production of sterile drugs not only needs to determine the cleaning of the operators, but also to ensure that the equipment is free of pollution. For example, filtration is a part of the production of sterile pharmaceuticals. The cleansing of the filtration equipment can affect the clean production of the medicine. If the washing is wrong, the medicine is likely to cross-contamination. Therefore, even if high-quality pharmaceutical equipment is introduced, pharmaceutical companies should pay attention to the use and cleaning of equipment to ensure the quality and safety of medicines.
The clues to the pressure of releasing pharmaceutical companies, the innovation and upgrading of pharmaceutical equipment can not be ignored
In addition to the above-mentioned aspects, 44 documents include policies for the transfer of traditional Chinese medicines, innovative medicines, and the promotion of new drug research and development results and the flow of production technology. One of the direct signals for pharmaceutical companies to upgrade their pharmaceutical equipment is innovation. The “innovation†here mainly refers to innovative pharmaceutical equipment, including products that combine the current trends of automation, intelligence, energy conservation and environmental protection.
The author believes that the pharmaceutical industry is actually an industry that uses innovation as an energy source. Under this circumstance, pharmaceutical companies are faced with multiple pressures: capital pressure when developing drugs, environmental pressure, and pressure from market competition. Pharmaceutical companies can indeed shout "the pressure is great!" But apart from each other, innovation is actually an important clue to connect these pressures. Regardless of the pharmaceutical process, the pharmaceutical companies need to pay attention to the innovation and upgrading of pharmaceutical equipment.
At present, in the domestic market, thanks to the promulgation and implementation of favorable pharmaceutical policies, innovative pharmaceutical equipment is innumerable. In order to keep up with the pace of development of the times, pharmaceutical companies actively integrate advanced concepts, research and development to meet the needs of pharmaceutical companies. Pharmaceutical equipment. For example, Chutian Technology's intelligent manufacturing new model project based on intelligent robots; modern Chinese medicine formula granule preparation equipment in smart pharmacy; Taicang Jinxi's intelligent environmental protection ultra-fine powder test center.
The innovative pharmaceutical products that the pharmaceutical companies put on the market can not only play a role in the supervision process, but also improve the production efficiency for the pharmaceutical enterprises. For example, Kunming Pharmaceutical Group's “natural plant drug extraction intelligent manufacturing pilot demonstration†project in the production workshop reflects the characteristics of intelligent manufacturing, automation, and digital. It is reported that the production workshop will use innovative pharmaceutical equipment. After the project is completed, it can automatically select, extract, separate, purify and refine the total saponins of Panax notoginseng, which can improve the extraction technology and quality control level of raw materials. Bring benefits to benefit.
The pharmaceutical industry has been the status quo of continuous policy and continuous reform, and the industry as a whole is facing a major reshuffle. As the main body, the pharmaceutical enterprise team will usher in a baptism, and pharmaceutical companies that do not meet the development trend of the industry will not be able to avoid the fate of being eliminated. Faced with the “crisis†already on the road, most pharmaceutical companies are starting from the aspects of pharmaceutical technology, production links, and enterprise management, and actively take measures to transform and upgrade. Despite this, there are still many pharmaceutical companies neglecting the importance of upgrading pharmaceutical equipment. Here, the author also reminds the majority of pharmaceutical companies that as a direct contact with drugs, the upgrading of pharmaceutical equipment cannot be ignored, whether it is quality upgrade or innovation. Upgrade, high-quality, high-tech, high-end pharmaceutical equipment will bring more benefits to pharmaceutical companies. Therefore, we must seize the opportunity, and the "crisis" has not yet come fully, and pharmaceutical companies can take action.
(Author: Fan Ying)
Ningxia Eppen Biotec CO.,LTD , https://www.nxeppen.com