â€œThe new GMP has a much higher cleanliness requirement for the production of sterile drugs than the 98 version. The reform and upgrading of the drug plant has brought a lot of pressure, but at the same time, the pharmaceutical equipment industry has ushered in the development of submersibles. Two days of sorrow and joy." A research expert in the law told the reporter of the Pharmaceutical Economics.
Although the revised version of GMP has not been unveiled several times, the requirements for improving management standards, especially for aseptic production, have been clarified. The resulting upgrade of equipment means an increase in costs, but the state controls the terminal price. The manufacturer of the aseptic preparation is in the place of the crack.
Contrary to this, the pharmaceutical equipment industry is full of joy, because the new version of GMP will expand the space for the development of the industry.
Request to improve equipment must be upgraded
It is reported that the relevant technical aspects of the new GMP revision have all been completed, and the Ministry of Health has been reported to the Ministry of Health in June. The industry generally believes that the new version of GMP is closer to the requirements of the EU GMP, and the difference with the 98 version of GMP is mainly reflected in the upgrade of management standards, especially the production of sterile drugs.
â€œIncluding the design concept of the plant and the sterility management concept are changing.â€ The senior document of the Northeast Pharmaceutical Factory believes.
Liu Shulin, the head of the quality of the new cephalosporin project in North China Pharmaceuticals, said that in the production environment, the new GMP classifies the cleanliness required for pharmaceutical production into four levels: A, B, C, and D. Among them, the A grade is the 100-level flow grade. Mainly for high-risk operation areas, such as filling, placing rubber stopper barrels, aseptic assembly or product exposure operation area; Class B is equivalent to the original static level 100, with dynamic standards, mainly aseptic configuration and filling, etc. The background area in which the high-risk operating area is located, and dynamic continuous monitoring. For the exposed areas of sterile drugs, the 98 version of GMP requirements are 100 levels in the 10,000-level background, and the new version is the A-level in the B-level background. For the B-level regional and technical standards, taking the requirement of 0.5 micron suspended particle zui large allowable number/m3, the new version of GMP B requires dynamic particles, the number of particles larger than 0.5Î¼m is lower than 350,000, 98 version of GMP The corresponding requirement of 10,000 grades is static below 350,000. The difference between the static and the dynamic is very high.
In addition, in environmental monitoring, the new version of GMP requires continuous dynamic monitoring for Class A and Class B areas, while the 98 version of the standard does not explicitly require this, companies can choose to monitor each batch or monthly.
â€œThe new GMP does not list specific requirements for production equipment, but to meet new environmental and verification standards, equipment must be upgraded and upgraded, including air conditioning systems, environmental monitoring and control systems, and equipment itself.â€ Liu Shulin said, in addition to this. In addition, linked to GMP is the 2010 version of the Pharmacopoeia requirements for water for injection, that is, the total organic carbon must be tested, and the water treatment system and purified water equipment of the production enterprise need to be modified.
Costs are soaring
The transformation of the production line requires huge investment. Statistics show that the total investment may be between 6 billion and 9 billion yuan due to the improvement of the standards for sterile drugs, and some enterprises may even need to stop production. There are 491 freeze-dried powder antibiotics, of which 298 are GMP certified before 2002, and the cost of each enterprise may need to be 20-30 million yuan.
In the case of sterile drugs, mainly management standards and hardware facilities upgrades, involving ventilation systems, water systems, online testing, etc. In particular, the monitoring of the environment, from the original static standard to the dynamic standard, requires enterprises to conduct online monitoring, and some domestic equipment can not meet this requirement, and the investment in repurchasing equipment is huge.
The new version of GMP requires that the rolling process of non-zui final sterilization drugs must also be carried out in the A-level area under the B-level background. The renovation of some enterprises' plants is very difficult, which also arouses the concern of the responsible person of the enterprise. In addition, the increase in cleanliness leads to an increase in energy consumption, which is also a long-term cost. Liu Shulin told reporters that according to preliminary estimates, in general, according to the new version of the sterile preparations, the production cost, operating cost and management cost may add up to two times.
A CEO told reporters that he felt that it was difficult: "cost increases, price control, whether the company is producing or discontinuing production?" The boss said that he is currently considering whether to stop production of some products with low added value.
Suspension of production will lead to a decrease in market supply, and the price of pharmaceutical terminals may rise; continue to produce, the cost of enterprises will increase substantially, and the downward transfer of pressure will cause product price increases. Under the contradiction between rising costs and the state's control over the price of drugs, the company seems to have reached a crossroads.
Liu Shulin believes that in this case, the implementation of the new version of GMP should be linked with the new medical reform. If the new medical reform can successfully reduce the intermediate link of drug sales, change the current situation of taking medicine and medicine, so that the pharmaceutical factory can have reasonable profits after the transformation, and may be able to solve the cost pressure that the enterprise is currently facing.
Opportunity comes to the expansion of procurement
Compared with drug manufacturers in dilemmas, pharmaceutical equipment companies are enjoying the joy of market expansion brought about by the new version of GMP.
Statistics show that since the mandatory implementation of GMP in the country in 2004, the total investment in GMP certification in the country has reached 150 billion yuan.
According to the statistics of China Pharmaceutical Equipment Industry Association, the total output value of China's pharmaceutical equipment industry in 2009 was about 19 billion yuan, and the sales revenue exceeded 18 billion yuan. Compared with 2008, the total industrial output value increased by 13.5%, the sales revenue of products increased by 13.2%, and the profit increased by 11%. The statistics of 231 large-scale pharmaceutical equipment enterprises showed that the sales volume of sterilization equipment was 9013 sets (sets). .
According to the analysis of China Pharmaceutical Equipment Industry Association, in addition to the social demand for rigid demand for pharmaceutical products, the implementation of the new medical reform program and the implementation of the new GMP will be favorable factors for the development of the pharmaceutical equipment industry.
Previously at the 2010 World Pharmaceutical Machinery, Packaging Equipment and Materials China Exhibition, Liu Jun from Hunan Huiyi Pharmaceutical Machine also revealed to reporters that in 2009, the sales of Huiyi Pharmaceuticals reached more than 1 billion, and the growth in the first half of this year was even more It is gratifying.
"It's too busy to come." He said with delight, that the company's sales, including the company's old equipment renovation and new projects, "is at least 20% to 30% growth compared with last year's Zui."
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