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    Home > Medical News > Latest Medical News > New version of GMP unveiled in the pharmaceutical industry's eyes china-pharm exhibition

    New version of GMP unveiled in the pharmaceutical industry's eyes china-pharm exhibition

    • Last Update: 2020-06-04
    • Source: Internet
    • Author: User
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    Business Agency September 13th, the new version of GMP before and after more than ten draft revisions, in September and December last year, two public consultation, is now officially entered the trial stage, and is expected to be introduced this yearBecause the new version of GMP on the domestic pharmaceutical equipment put forward higher requirements, whether pharmaceutical manufacturers, or pharmaceutical equipment enterprises, will face a new round of survival challengesIs a challenge is also an opportunity, in the face of huge industry expansion space, how to adapt to the new situation, improve competitiveness, china's pharmaceutical industry has become a new topicbased on this, the 15th China International Pharmaceutical Industry Exhibition and Technology Exchange , China Pharmaceutical Industry International Forum (CHINA-PHARM 2010) will be held from October 26 to 29, 2010In the course of 15 years of development, CHINA-PHARM has witnessed the growth of China's pharmaceutical industry and the implementation of GMP, has become the most authoritative, cutting-edge industry exchanges and cooperation platformthe new version of the GMPin line with international standards
    it is understood that the new version of GMP combined with China's actual situation, covering the Eu, the United States FDA, WHO on the basic requirements of GMP, including hardware content reference the European Union, software reference to the United States, which also shows that China'sdrugquality standard system has extended to the basis and source of drug production, began to be truly in line with international standardsAccording to Feng Yuan, senior engineer of Tianjin Pharmaceutical Research Institute Pharmaceutical Co., Ltd., China's current implementation of the GMP norms in the technical requirements of the standard is basically equivalent to the WHO set the level of applicable to developing countries, in the specific provisions combined with China's national conditions have made corresponding adjustments, with the current international advanced level there is a considerable gap, not timely improvement will bindpharmaceuticalthe sustainable development process of the industryThis is also one of the reasons why Our country is actively promoting the new version of GMPas the head of the International Pharmaceutical Engineering Association (ISPE) China Technical Committee, Bayer Technical Engineering DrChunhua Zhao has been very concerned about the revision process of the new version of GMPHe believes that the existing GMP and the latest international standards in the hardware requirements and quality system have a considerable gapIn recent years, the international GMP requirements gradually tend to drug quality life cycle, quality from the design, quality risk management and so onThese new ideas have not yet been popularized in ChinaThe new version of GMP is a big step forward in aligning with international standards, with the concept of quality risk management mentioned in hardware such as the dynamic requirements of particles in clean zones and softwarethe new version of GMP in line with international standards, Feng Yuan said: "according to cGMP standards to regulate the entire drug production and marketing process is an essential prerequisite for the road to internationalization." The positive significance of the new version of GMP is to narrow the gap with cGMP, improve the aseptic safeguards required by sterile preparations, and clearly define all aspects of the whole process of pharmaceutical production, i.efrom the material, production, quality and salesMore important is to update the concept, the implementation, management and monitoring responsibilities of those directly involved in drug safety at all levels are more clear, and the work of promoting the quality of medicines to meet domestic and foreign market demand is a practical preparation"
    in this new version of the GMP revision, theimpact onenterprises is the most affected by sterile drugsDue to the occurrence of some drug harm incidents, this GMP revision, especially to add the drug sterilization and sterilization chapter, and the drug sterilisation filtration is the most importantCHINA-PHARM sponsor China Pharmaceutical International Exchange Center (CCPIE) and the International Pharmaceutical Engineering Association (ISPE) in theexhibitionof the same event - 2010 International Pharmaceutical Engineering China Conference held a special group forum for aseptic production, Dr Zhao Chunhua will be co-chair of the aseptic forum It is reported that, in addition to the aseptic forum, the 2010 International Pharmaceutical Engineering China Will will arrange from the pharmaceutical regulatory departments, research institutions and pharmaceutical enterprises domestic and foreign experts on-site lectures, group forum topics include the pharmaceutical industry clean verification, solid oral preparations, technology transfer (research and development to production), commissioning and confirmation, product quality life cycle realization, computer system compliance noteworthy, china-PHARM exhibition has many special for domestic pharmaceutical companies to carry out technical training, verification and consulting services of international companies have been ready to provide domestic enterprises with the most advanced technology services the world's first manufacturer of ultrapure water systems, CHINA-PHARM, one of the exhibitors of the Company is ready to serve the domestic aseptic pharmaceutical companies The company has a "
    regulatory and verification department" and a "BioMonitoring Department," according to the company's officials Since 2007, at the invitation of the National Food and Drug Administration Training Center, it has participated in dozens of trainingsessions for aseptic pharmaceutical manufacturers, quality assurance personnel and GMP inspectors In addition, Millibo also established a "sterilizing filtration validation laboratory" in Shanghai Zhangjiang Hi-Tech Park, the main purpose is to provide domestic pharmaceutical manufacturers with verification services and advice, such as: bacterial challenges, compatibility, precipitates, product integrity testing At the same time, the new version of GMP's cleanroom level standard (A, B, C, D) also put son and challenges for non-final sterile pharmaceutical manufacturers How to evaluate and verify the facility, the monitoring and control of the production process has become a new GMP implementation topic BioMonitoring offers a comprehensive solution for the detection of plankton, compressed air microorganisms and surface microorganisms the active preparation of international pharmaceutical equipment suppliers has also inspired domestic pharmaceutical equipment companies to rapidly upgrade their technology level and accelerate development pharmaceutical equipment industry ushered in the development of spring
    from small single pharmaceutical machinery to complete specifications, production lines complete pharmaceutical equipment, the development of China's pharmaceutical equipment industry has made great progress Especially since the implementation of the Drug Production Quality Management Practice (GMP) certification system in 1998, the technical level, quality and product specifications of products in the pharmaceutical equipment industry have been significantly improved and developed However, the gap between China's pharmaceutical equipment industry and foreign pharmaceutical equipment industry is still obvious Beijing Shuanghe Pharmaceutical Equipment Co., Ltd is the backbone of China's pharmaceutical equipment industry, with nearly 40 years of development history, for the development of China's pharmaceutical equipment industry, is both a witness and a witness Fu Jianping, general manager of the company, believes that although China's pharmaceutical equipment industry has made great achievements, but many enterprises in the technical level is still basically in the imitation, improvement and combination stage, did not reach the level of innovation or more than similar products in the world At present, China's pharmaceutical equipment and foreign pharmaceutical equipment level compared with the overall difference of at least 10 years How to shorten the gap of 10 years, so that the level of domestic pharmaceutical equipment to a new level? Fu Jianping believes that the implementation of the new version of GMP will bring new opportunities for the development of the domestic pharmaceutical equipment industry "The implementation of the new version of GMP will promote the survival of China's pharmaceutical equipment industry, re-integration, improve the overall level of China's pharmaceutical equipment, so that it is closer to the international pharmaceutical production standards." "
    Enyi-Ma is a leading international engineering consulting firm in the field of pharmaceutical bioengineering, which has undertaken projects such as the design, construction and GMP compliance services of many domestic and foreign pharmaceutical companies Xie Jingjun, the company's quality verification manager, said that in the past, China's attention to pharmaceutical engineering is generally inadequate And the implementation of the new version of GMP, will certainly make pharmaceutical companies pay more and more attention to pharmaceutical engineering, more and more recognition of the value of pharmaceutical engineering Therefore, the implementation of the new version of GMP for the development of China's pharmaceutical engineering, is a favorable opportunity opportunities certainly only for those who are prepared Xie Jingjun also said that the implementation of the new version of GMP, but also requires the entire field of pharmaceutical engineering in line with international standards, to international standards However, the foundation of pharmaceutical engineering in China is relatively weak, the various guidelines are relatively few, and the relevant knowledge is insufficient Compared with international pharmaceutical engineering peers, lack of corresponding experience For example, whether the GMP regulations are well understood, whether the engineering methods used are advanced, and whether the design meets the economics of the enterprise and meets the requirements of the regulations Therefore, for China's pharmaceutical engineering, this is also a serious challenge "To be aware of the opportunities presented by the implementation of the new GMP, we must also be prepared to update our knowledge and improve our skills so that our pharmaceutical engineering can meet the requirements of the ongoing internationalization of pharmaceutical companies." "
    domestic enterprises must speed up the pace of internationalization
    with the development of China's pharmaceutical industry, the government has been introducing a new version of GMP, the public demand for high-quality drugs is also increasing, enterprises are constantly improving the quality of their own drugs, in addition to the supply of domestic market, many Chinese enterprises have also begun to embark on the road of export to the United States and the European Union To keep up with the development trend of international pharmaceutical industry, domestic enterprises must speed up the process of internationalization as a leading domestic solid packaging production enterprises, Beijing Shuanghe Pharmaceutical Equipment Co., Ltd also contracted some domestic enterprises GMP plant transformation projects For the future development of domestic pharmaceutical equipment enterprises, General Manager Fu Jianping believes that, on the one hand, domestic enterprises should aim at foreign countries, from the advanced equipment, stability to improve equipment; advanced enterprises abroad have a set of selection, control, evaluation and verification system to ensure product quality monitoring And domestic enterprises still have a long way to go in this area The relevant person in charge of Millibo believes that the new version of GMP not only to China's pharmaceutical companies put forward new requirements and challenges, but also to international pharmaceutical equipment suppliers put forward higher requirements, not only to be able to meet the new version of China's GMP hardware facilities, but also more and more to provide international standards of services, applications and training software and in the process of continuous internationalization of domestic enterprises, CHINA-PHARM, co-sponsored by the China Pharmaceutical International Exchange Center and Dusseldorf Exhibition (China) Co., Ltd., has undoubtedly set up a good platform for Chinese and foreign enterprises to display their image, obtain information, open up markets and promote exchanges it is understood that the CHINA-PHARM has previously domestic well-known exhibitors and international exhibitors have expanded the exhibition area, the German pavilion, Le Jiawen, Bosch, Oxing, etc have expanded the exhibition area Well-known enterprises, Such as Weishi Machinery Co., Ltd., Mikron Group, CKD, DAIICHI and other Japanese enterprises will continue to participate in the current CHINA-PHARM Japan Exhibition The UK pavilion, organised by PPMA UK Processing and Packaging Machinery Association, will also be unveiled for the first time at CHINA-PHARM 2010 for this year's CHINA-PHARM, Feng Yuan is most concerned about the "blow-irrigation-seal" three-in-one (BBFS) (Blow/Fill/SeaI) technology used in the pharmaceutical industry, which is a sterile packaging technology It is on a single machine, in a work cycle, once completethe bottle, filling, sealing process Since there is no exposure throughout the production process, the possibility of external environmental pollution products can be completely avoided Feng Yuan said: "'blow-sealing' technology in the use of large-capacity injections, in recent years, Europe and the United States in the plastic ampoule water needles and eye drops also have more use, there are many domestic eye drops manufacturers a large number of introduction The new version of GMP to explain this, is conducive to the wide use of plastic ampoule water needle in Europe, this dosage type has been popularized in China
    "CHINA-PHARM provides a great platform to connect equipment manufacturers, technology service providers and pharmaceutical manufacturers to showcase the most advanced equipment and technology in the world and at home, and this will be a great event for exchanges, which we look forward to." Xie Jingjun said
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