“In order to pass the new GMP certification, we started to prepare from 2011 onwards and we did not pass the certification until the first two months.” Wang Yu (a pseudonym) is a staff member of a pharmaceutical company in Northeast China. The main task of the two years is to be responsible for the new version of GMP. Certification.
“I came to Beijing almost every month, and the GMP certification center went more than 10 times. It was better to pass the certification before the GMP deadline.” Recalling the certification process, Wang Yu still has a fear.
The advent of the new version of the GMP "test" has made every drug company nervous. GMP is a set of mandatory standards applicable to pharmaceuticals, foods and other industries. It requires companies to meet hygiene quality requirements in terms of raw materials, personnel, facilities and equipment, production processes, packaging and transportation, and quality control in accordance with relevant national laws and regulations. In other words, GMP certification is a threshold for pharmaceutical companies.
According to the announcement of the State Food and Drug Administration, as of December 31, 2013, of the 1,319 sterile pharmaceutical manufacturing enterprises in the country, 796 companies had passed all or part of the workshop certification, accounting for 60.3%.
According to the announcement, as of January 1, 2014, aseptic pharmaceutical manufacturers or production plants that have not passed the new version of GMP certification will stop production. After an enterprise ceases production, if it completes the new version of the drug GMP reform, it can continue to apply for certification; enterprises that abandon the certification can withdraw in an orderly manner through independent selection of technology transfer of varieties, merger and reorganization of enterprises.
Wang Yu told reporters: “The majority of companies that have passed the new GMP certification are large companies. Small businesses do not pass much, because the cost of retrofitting is not a small figure for companies.”
Statistics show that in the last round of GMP certification, a total of 3,959 manufacturing companies passed the total cost up to more than 150 billion yuan, and about 1,400 companies that failed the GMP certification were eliminated.
The relevant person in charge of the Drug Safety Supervision Department of the State Food and Drug Administration had publicly stated that it is expected that the company will comply with the new regulations and that only the total hardware investment will require 200 billion to 300 billion yuan.
Yu Mingde, president of the China Pharmaceutical Enterprise Management Association, told reporters: “The new version of GMP certification requires higher hardware requirements and more stringent air purification standards and cleanliness standards for aseptically produced drugs. This standard is relatively high, It has reached the level of the European Union. Therefore, it is necessary for companies to transform their equipment into larger investments.” Guo Fanli, Research Director of China Investment Consulting Co., Ltd. analyzed: “In response to the newly revised GMP requirements, companies will invest heavily in new plants, or existing pharmaceutical production plants and air-conditioning. If the system is to comply with the new GMP requirements, companies will invest at least tens of millions of yuan, and the high ones will cost 100 million yuan."
In addition to the high hardware requirements, the new version of GMP also adds requirements for risk management systems, design verification systems, job training systems, change control systems, and deviation handling.
“These systems are feasible, but they are quite complex to implement and require a relatively long period of time.” Yu Mingde said, “This will be a relatively concentrated survival of the fittest, and leading companies with leading technologies can ultimately Benefit."
Yu Mingde predicts that 20% to 30% of companies will withdraw from the market, especially small enterprises that cannot withstand severe tests.
“The previous round of GMP certification was in 2004, and it was relatively rigorous in the early stage, but it was followed by a phenomenon of “draining.” Even so, there are still 25% of drug companies exiting the market. The new version of the GMP standard has been greatly improved, and stricter in terms of customs checks. "Even if Wang Yu's drug firm is strong in capital, it still feels it is more difficult to pass.
Zhang Wensheng, a lawyer in the pharmaceutical industry, told reporters: “Small and medium-sized pharmaceutical companies are in a very embarrassing situation. They are not willing to withdraw from the market and they cannot afford to renovate. GMP certification is a barrier to entry, companies will try their best to pass certification, and small businesses want to spend The minimum amount of money is certified, and the local government will not watch these companies die, and often do some workarounds."
Yu Mingde also said that the previous round of certification GMP standards did indeed occur soon after the phenomenon of loose, regional differences: "Currently it seems that the shut is more stringent, and now GMP certification from Beijing to grasp the end, the power is not decentralized to the local , but eventually it will not be 'discharged' it is still hard to say.”
Small businesses may take the risk of overcapacity The problem of overcapacity has always plagued the pharmaceutical industry. Due to the low entry thresholds for old GMP certification, and the existence of small, chaotic and scattered pharmaceutical companies, excess capacity in the sterile pharmaceutical market is equally serious. Many drugs The competition of similar products is fierce, and the process and technology are often closed.
The head of the Respiratory Department of Peking University’s People’s Hospital had publicly stated that, in recent years, the incidence of adverse reactions to aseptic drugs in the clinic has been high. Generally, allergic reactions are manifested. In severe cases, shock or even death occurs. These adverse events, in addition to the physical factors of individual patients, are closely related to the quality of medicines.
According to an announcement by the State Food and Drug Administration, only 60.3% of the aseptic drug manufacturers have passed GMP certification, but the total production capacity has reached more than 160% of the market's actual demand in 2012 and can meet market supply. The problem of excess capacity is evident.
Yu Mingde said that even without this round of new GMP requirements, there is a group of companies that are facing aseptic preparations. He said: "China's pharmaceutical products in terms of production capacity and utilization, the sterile powder in the formulation is the lowest. Utilization rate is 27%, 73% excess, is the largest production capacity among the many types of formulations, the highest excess ratio, production capacity utilization The lowest dosage form."
Foreign companies are committed to independent research and development. There are not many manufacturers of the same product, and they are basically generic drugs in the country. The technology can't be separated by gaps, so companies can only fight costs.
Zhang Wensheng, who has been immersed in the pharmaceutical industry for many years, said: “Some small businesses are forced to take risks through competitive pressure. Some companies only put part of their production lines into production through GMP certification, and even several companies share a drug lot number.”
Zhang Wensheng told reporters: "Some small businesses have become destabilizing factors in the pharmaceutical market, and vicious competition is serious. New GMP certification will allow companies that do not meet the regulations to withdraw from the market and ease the situation of overcapacity, which will help achieve fair competition."
The pharmaceutical equipment that benefited From 1998 to 2004, the demand for pharmaceutical equipment in China witnessed rapid growth. With the end of the previous round of drug GMP certification, the growth rate of the industry has slowed since 2005, and the new version of GMP has made higher demands on hardware. The request also brought dividends to the pharmaceutical equipment industry.
Chutian Technology is one of the largest biomedical equipment R&D and manufacturing companies in China. Its prospectus shows that in 2012 it achieved tax-included sales of 688 million yuan, and tax-free sales revenue of 58.87 billion yuan, an increase of 45.52% over the previous year; The profit was 92.74 million yuan, a year-on-year increase of 55.99%.
The two companies listed on Dongfanglong and Qianshan Pharmaceutical Machinery also benefited significantly. In 2012, Dongfulong achieved operating revenue of 820 million yuan, an increase of 26.66% year-on-year, and net profit of 230 million yuan, a year-on-year increase of 7.33%; The company achieved operating income of 360 million yuan, an increase of 38.25% year-on-year, and a net profit of 71,213,400 yuan, an increase of 38.14% year-on-year.
Zhao Lin, deputy secretary-general of the China Pharmaceutical Equipment Association, told the reporters of the Rule of Law Weekend: “If a pharmaceutical company conducts GMP certification, it must first carry out the transformation. The transformation is multi-faceted. The software and hardware must be transformed. The hardware includes the transformation of plant and equipment. During the transformation period, the sales momentum of the equipment companies will be very good, and the company's sales will increase substantially."
Zhao Lin recalled: “The last round of GMP certification was in 2004, which was also the peak year for sales in our pharmaceutical equipment industry. However, after 2004, the entire industry entered a low point. After certification, companies are difficult to achieve within 3 to 5 years. Then make a big investment transformation."
"The new version of GMP certification is more stringent. Many companies cannot fool themselves. They can only buy good equipment." Zhao Lin believes that this is overall good for the pharmaceutical equipment industry. "The increase in market demand has also attracted capital and technology." Influx of personnel, some of the marginal enterprises in the GMP certification period to switch to pharmaceutical equipment, such as chemical companies, health products companies."
President Yu Mingde believes that the pharmaceutical equipment industry may not usher in the spring: “Compared with foreign countries, there is still a big gap in the pharmaceutical equipment industry in China. Take aseptic preparation equipment as an example, foreign equipment technologies are more mature and provide The entire production line, many pharmaceutical companies will choose to purchase foreign equipment, which is a challenge for the domestic pharmaceutical equipment industry."

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