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The revised GMP certification in case the opportunity to promote the drug packaging upgrade

發布日期:2015-4-3    閱讀數:1686

Earlier this year, the largest injection vials, ampoules production companies & mdash; & mdash; Chongqing is Sichuan Glass Ltd Level 1 water glass double start running at full capacity. April 17, Xiao Qing Chuan are glass sales director said, because the water level Dual 1 glass of low borosilicate glass is higher than the price of 30% & mdash; & mdash; 50%, last year demand is relatively limited, furnaces operating at only 50%. But this year with the newly revised GMP certification progress, pharmaceutical companies to package material quality requirements increase, double the current level 1 water glass operating rate reached 100%.

According to the newly revised GMP certification process, has certified sterile preparations completed at the end of this year to be fully certified solid preparation. Our Medical Packaging industry started late, the technical level is relatively backward, under the newly revised GMP certification to promote industrial upgrading urgently. Dingjijiaose domestic pharmaceutical production enterprises Jiang 陰華蘭 New Material Co., Ltd., Hua Guoping said the new revised GMP drug packaging industry is an opportunity to upgrade and enhance the role of standards are emerging.

Medical Packaging raise standards

It is understood that the newly revised compared to the biggest change is to improve the cleanliness requirements for sterile preparation of the production environment, especially in the packaging process validation of injection drug manufacturers, and sterile GMP with the old version, purification plant transformation requirements are more stringent, and therefore a large infusion packaging, pharmaceutical glass containers and other packaging and raw materials, spare parts and so faced with the upgrade. If the drug packaging quality tests, not only causes pollution active pharmaceutical ingredients, adsorption or chemical reactions, making it inferior quality, more serious cause toxic side effects.

Hua Guoping said drug packaging pros and cons depending on the fit of the drug, the technical difficulty is that in the middle of compatibility, extractables, migration, etc., but at this stage of drug packaging business drug compatibility test superficial knowledge, research is still very limited. In addition, due to drug packaging industry is profit, industry-wide lack of R & D investment, by a single enterprise compatibility study is not realistic.

As we all know, a product of more regulation, a multi-product pharmaceuticals formulations are the norm, which determines a wide range of drug packaging, and all drugs have carried out compatibility tests really huge one. The actual situation, China's authorities and industry organizations have introduced a number of technical standards and guidelines, trying to build a complete Medical Packaging Quality Control System.

Xiao Qing, said since the implementation of the revised GMP, feel the biggest change is the pharmaceutical companies for drug packaging requirements more stringent, and in the production of documents, records of raw materials purchasing, increased on-site inspection, etc. efforts.

Shanxi Guangsheng capsule Limited, the official said, was a big storm capsule capsule inspection industry, survival of the fittest clean up the market. After the implementation of the revised GMP certification, some low-end production out of the market, industry concentration, and capsule products have also been disrupted battle to reverse the situation. Guangsheng capsule from customers point of view, involves more and more widely, the original company's customers are mainly large domestic enterprises and foreign invested enterprises, small and medium sized pharmaceutical companies are now also began to favor good capsules.

cost driver has not been reversed:

related statistics, China's total of more than 1,500 drug packaging companies produce more than 90 percent of drug packaging products, but mostly small-scale, technology and management level is not high, the low-end products low-level repetitive serious. Jiangsu Run De Zhu Shan Medical Materials Co., Ltd., chairman of the said order Dingjijiaose example, manufacturers from the initial development of a few to more than 50 production licenses, serious excess capacity, there are now half of the enterprises in the cut or semi-shutdown state, companies started underemployment.

film stopper is to solve the stopper and drug compatibility, reduce security risks and develop a stopper products, widely used in high security ceftriaxone injections and biological products. In the beginning of the product development, the country is less than 10 manufacturing enterprises, with an ordinary stopper fierce competition, low profit era, the film became a stopper in the eyes of many enterprises & ldquo; & rdquo ;, Blue Ocean registration application are numerous . Up to now, only the stopper film production reached more than 30 companies. 20 specifications of the film stopper for example, the price from 0.8 yuan & mdash; & mdash; ranging from 0.12 yuan. Hua Guoping said, according butyl collagen material and production costs calculation, a loss of 0.12 yuan.

& ldquo; some companies in order to seize the market, squeeze competitors at a loss leader, this bad acts of unfair competition seriously disrupt the market. & Rdquo; Xiao Qing said.

In fact, behind every drug packaging business is fierce competition in supply and demand at work. Pharmaceutical companies on upstream costs continue to squeeze companies make packaging materials conform work again. & Ldquo; drug tender & lsquo; the only cheap is to take & rsquo; after the implementation of the policy, including timber business harder. & Rdquo; Hua Guoping said.

Currently, the drug is usually valid for two years, but some medicines listed eight months on the critical period of limitation. National authorities repeatedly checks showed that infusion of clarity, liquid color is a major non-conformance, and these unqualified items associated with a large bag material. & Ldquo; some companies to reduce costs as a package of material items constantly squeezed. They felt very clear, with a low-quality packaging materials packaging products the likelihood of migration of substances is very large, failed to reach the two-year limitation period, it increased marketing efforts, hoping to use the shortest possible time to sell them drugs. & Rdquo; an industry source said.

It is not enough

rely on self-regulation

pharmaceutical packaging industry & ldquo; second five & rdquo; Development Program's main task is to improve industry concentration through association, merger, reorganization, etc., while optimizing existing product variety of pharmaceutical packaging materials, promoting pharmaceutical packaging industry balanced regional development; step by step to improve the various types of pharmaceutical packaging products, innovation and R & D capabilities; develop standardization strategy, the establishment of a scientific and rational development goals standardization system is also the industry reached a basic consensus. Zhejiang Province, has been basically formed the industrial layout medicinal capsule Xinchang area, Taizhou, Wenzhou, Yuhuan pharmaceutical packaging area and pharmaceutical equipment area.

Hua Guoping believe that our drug packaging development today, facing a major transformation, and product standards to upgrade, improve the quality of industry self-regulation alone is not enough, lengthy process. & Ldquo; If you do not change the cost-oriented business model, not to mention drug packaging business discipline. & Rdquo; he called on national authorities should increase the drug inspection efforts, especially for 20 months has been listed products will be seized items as strengthen inspection. In addition, the Association and other industry organizations should regularly publish test results, public muckraking, provide the basis for pharmaceutical companies looking for high-quality packaging materials businesses.

It is reported that since the implementation of the revised GMP, capacity expansion of domestic drug packaging enterprises are carried out simultaneously, has quietly begun a new round of competition. The future development of new products, optimize the product structure, improve the technical level, energy consumption will be a test drug packaging rigid target core competitiveness of enterprises, enterprise breakthrough path also contains them.

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