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The new version of GMP unveiled
Since the beginning of May this year, experts from the China Chemical Pharmaceutical Industry Association, China Medical Engineering Equipment Association, and China Traditional Chinese Medicine Association have made extensive recommendations on the new GMP. The new version of GMP adopts the framework of the basic requirements plus the appendix. According to Gu Weijun, Secretary General of China Medical Engineering Equipment Association, the appendix of the new GMP has special requirements for the type and technical management of specific drugs, and can be increased step by step to meet the regulatory needs; and can be supplemented at any time according to the needs of development and supervision. Or add a new appendix. The reporter saw that the new version of GMP covers basic requirements as well as five appendices for sterile drugs, Chinese medicine preparations, APIs, biological products and blood products. The non-sterile drug appendix in the original 98 version of GMP is required to be incorporated into the basic requirements. The 98 version of GMP in Chinese medicine decoction pieces, radioactive drugs, medical gases and other appendices continue to be used, not revised, and the new version of GMP does not adapt to the new version. In this way, the pharmaceutical GMP for enterprises will have one basic requirement, five new appendices and three old appendices. Among them, the basic requirements, the sterile drug appendix is ​​the top priority of this revision work, and the blood product appendix is ​​the new appendix added in this revision.
In the revision, the new version of GMP refers to and draws on the basic requirements of the EU GMP and the relevant requirements of the WHO. The main documents (such as quality standards, production process regulations, batch production records and batch packaging records, etc.) are specifically written in different categories; The copying and distribution of production and batch packaging records have put forward specific requirements, which greatly increases the difficulty of operation of illegal records and irregular records. In the revision of the basic requirements of the new GMP and the five appendices, the international GMP standards were referenced, and chapters such as quality risk management, supplier audit and approval, change control, and deviation processing were added to strengthen the control of relevant links in domestic enterprises. And management. It is worth noting that the new version of GMP introduces or clarifies some concepts, some of which have already been implemented in production enterprises, and some are being tested in some provinces in China. For example, product release person in charge, design confirmation, change control, etc.
The person in charge of SFDA said that the 93 version of GMP has content principle, clause, lack of guidance and operability, enterprises pay insufficient attention to software standards, and there are differences in the relevance of individual standards and policies. The new version of GMP will be targeted. Solve these problems sexually. "At present, China's pharmaceutical industry has excess capacity. The utilization rate of tablets, capsules and water needles is 45%, 40% and 50% respectively. The utilization rate of powder injection preparations is only 27%. The whole industry has heavy certification and light management. Phenomenon, this must be reversed."
As we all know, the 98 version of GMP certification is based on the safety level of the sub-industry to the public's life and health. The industry that Zui first certified is blood products, powder injections, and large-volume injections. The new version of GMP is also in these industries in terms of improving software standards.
Gu Weijun said that the new GMPzui changes will come from the field of sterile products, and non-sterile products will not change much. The new version of GMP adjusts the cleansing requirements of sterile preparations, increases the requirements for online monitoring, and refines the requirements of the medium; the purification level adopts the standards of the European Union and implements the A, B, C, and D standards. The A level is equivalent to the original dynamic level 100; the B level is equivalent to the original static level 100, with dynamic standards; the C level is equivalent to the original 10,000 level, and there are also dynamic standards; the D level is equivalent to the original 100,000 level. Under the four-level purification standard, the non-zui final sterilization exposure process needs to be produced in the Class A area under the B-level background. The gland must be produced in the Class A area under the B-level background. If desquamation occurs, it should be isolated separately. . At the same time, the aseptic processing of aseptic bulk drugs is also included in the management of sterile drugs. The crushing, sieving, mixing and packaging need to be produced in the A-class area under the B-level background, after the sterile Chinese medicine preparations. The refining process should be completed at least in the Class C clean area.
"At present, the cleanliness requirements implemented in China are different from the WHO standards and EU grading settings. Most large-capacity injection companies and some freeze-dried powder enterprises need to be reformed. According to preliminary statistics, 70% of large-capacity injection workshops in the country should be reformed. Less than 10 PE materials are used in freeze-dried powder injection workshops. Other materials are not resistant to high temperatures, and there are defects in freeze-drying technology, which cannot meet the requirements of the new GMP."
In this regard, SFDA officials said that from the occurrence of several phytotoxic events in recent years, many injection production companies have changed the production process and parameters, and replaced the medicinal raw materials with industrial raw materials. Therefore, improving software standards and implementing time and time tracking monitoring is a guarantee to improve product safety factor.
All along, there are two different voices in the new GMP revision process: the management department repeatedly emphasizes “no toss, smooth transitionâ€; production companies believe that the new GMP requirements are too high, and a considerable number of SMEs will face elimination.
Pharmaceutical companies face big exams
At present, enterprises are concerned about the implementation of the new version of GMP in two aspects: first, the ratio of input to output; second, whether technical equipment can meet the requirements. According to estimates, if the air purification system is modified separately, the enterprise needs to invest about 1 million yuan, and the total investment in the country is 298 million yuan. The price of domestic freeze-dried powder needle machine is between 20 million and 30 million yuan, and the zui low is also more than 10 million yuan. It is only necessary to replace the equipment. It is estimated that the national investment will be 6 billion to 9 billion yuan. At the same time, relevant experts reminded that since China began to carry out GMP certification in 1998 and the mandatory implementation of GMP in the country in 2004, the total investment in GMP certification in the country has reached 150 billion yuan, of which 40% are bank loans. According to the survey, so far, nearly 40 billion yuan of funds are still bad debts, and the impact of the financial crisis on the real economy is that the break of the capital chain has caused enterprises to fall into a quagmire.
Harbin Pharmaceutical Factory is a domestic powder injection manufacturer. The deputy director of the factory, Ma Jie, believes that the difficulty in implementing the new version of GMP is the quality monitoring in the production process, in which personnel training is a big problem. According to the requirements of the new version of GMP for quality releasers, the existing three-level quality management system of state-owned enterprises must be in line with international standards and become a secondary quality management system. After the system changes, the requirements for the quality management personnel are greatly increased.
General Meng Qiang of Henan Furen Pharmaceutical Co., Ltd. said that the new version of GMP has a relatively large change in purification grading. For many factories, the original factory was built, and then the renovation was carried out, and the space was not enough. According to the new standard, the B grade should be changed to the A grade, and the aluminum cover should also enter the aseptic area. The height of the existing factory building is 2.6 meters. If laminar flow is made, the space and noise heat dissipation problems are difficult to solve.
Duan Ping, the representative of Peking Union Medical and Pharmaceutical Co., Ltd., also felt deeply about this point. He said that the Concord Pharmaceuticals has a sterile preparation. According to the 98th edition of GMP, the purification environment only needs to be C grade. In order to ensure the quality of the drug, the company has taken the initiative to add a hundred levels in the C-level purification environment, but this is still far from the requirements of the new version of GMP. According to the requirements of the new GMP, this purification level must be changed from C to Class A under B. Compared with the requirements of purification level, dynamic monitoring of the purification environment is a big test for enterprises. According to him, at present, enterprises have generally implemented static monitoring; the implementation of dynamic monitoring means that online monitoring is necessary, and domestic equipment cannot meet the requirements of online monitoring. Enterprises must purchase foreign equipment, and the investment will be quite huge.
Longgang, the vice president of Oushi Pharmaceuticals of Shijiazhuang Group, has a deep understanding of this. He introduced that part of the factory's oral preparation workshop passed the EU certification, the investment is large, the operating cost is higher, but the efficiency is reduced by 5~10 times, and the fixed cost is increased by 2~3 times. Do, generic drug manufacturers can not afford, the input-output ratio is too low."
Bai Huiliang, former director of the Department of Safety Supervision of the State Drug Administration and executive vice president of the China Non-Prescription Drug Association, believes that it is a feasible path to guide enterprises to implement the new version of GMP certification through the mechanism.
In fact, SFDA is also very cautious about the revision and release of the new GMP, and many officials have repeatedly expressed their views on “not tossing†on different occasions. Among them, the relevant person in charge of the security inspection department said that after the completion of the revised version of the new version of GMP experts, economic evaluation should be carried out. The current opposition and support voices are fierce, but enterprises must see that this is a way for enterprises to change their business methods and re-strategize. The opportunity to locate. Chinese pharmaceuticals must go out of the cycle of low-level duplication, serious homogenization, and vicious competition. "We will definitely give the company a long transition period, which will be implemented in stages and in steps. Generally speaking, it takes 3 to 5 years for the technical transformation of the enterprise and 6 months to 2 years for the implementation of the regulations. I also remind you here. In the enterprise certification in 1998, the company has already tasted the consequences of irrational impulse investment. In the new round of certification, enterprises should fully conduct market research and invest carefully. We encourage enterprises to merge and restructure and adjust the product structure. Said the person in charge.
The new version of GMP revision refers to the weakness of pharmaceutical companies
" Now we are modifying the new version of GMP according to the expert opinion. Recently, the revised draft of the experts will be posted for comments. After further revision, we will strive to release it within the year. The new version of GMP will leave a considerable transition period from the release to the implementation." A few days ago, at the forum of the Shanghai World Raw Materials China Exhibition, the relevant person in charge of the State Food and Drug Administration (SFDA) said. Although it is still a long time from the release and implementation of the new version of GMP, but with the 98 version of GMP more emphasis on hardware facilities, the new version of GMP has greatly improved the software standard, which is tantamount to the weakness of the sword. The insiders describe the difference between hardware and software: the hardware can be seen and touched, and the software can't be seen.
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