Pharmaceutical equipment enterprises seize the new GMP opportunities need to be done to three tasks
February 12, 2011 March 1 implementation of the "Good Manufacturing Practice (revised 2010)" (hereinafter referred to as the new version of the GMP) caused by an industry-wide hot. The new GMP with reference to Europe and the United States GMP certification standards, and increased barriers to entry, the more stringent requirements of enterprise software and hardware. Many industry insiders believe that the introduction of the new GMP to promote the integration and restructuring within the pharmaceutical industry to enhance the overall level of the pharmaceutical industry to ensure the quality of medicines.
The new GMP for large pharmaceutical companies and small and medium-sized pharmaceutical points at two of the world
After the release of the new GMP, the different response of large pharmaceutical companies and small and medium-sized enterprises: the higher the starting point for large pharmaceutical companies by the new GMP less affected. Wu Jianming, the person in charge of the Beijing Double-Crane Pharmaceutical preparation workshop, said the new GMP amendments with reference to the GMP standards of the European Union and the United States, but it does not the EU, the U.S. GMP requirements strictly part of the Double-Crane Pharmaceutical products sold in Europe been in accordance with EU GMP standard management companies, so the new GMP on the Shuanghe the impact is not. "As Wu Jianming said, the new GMP Double-Crane Pharmaceutical Co., the large pharmaceutical companies, basically no effect on the large pharmaceutical companies plant, equipment has to meet the GMP standards, do not deliberately passed GMP certification for large-scale change. In addition, large pharmaceutical companies also have the advantage of funds, timely replacement of equipment.
Compared with the large pharmaceutical companies on the new GMP "poised", small and medium-sized pharmaceutical companies are a huge influence. According to incomplete estimates, the maturity of the new GMP, there will the 500-1000 substandard pharmaceutical companies have been eliminated. Lack of technology, capital for small and medium businesses want to continue to survive, only to strive for new GMP certification, make great effort in business management, equipment management, production management, quality management, in order to avoid the acquisition of large pharmaceutical companies or other fate of small and medium-sized enterprises to restructure.
Pharmaceutical equipment, how to seize the new version of the GMP opportunity
The new GMP to ensure that the pharmaceutical companies to produce products of high quality, high security, set a higher standard in the pharmaceutical equipment. Chapter device "GMP" Good Manufacturing Practice (revised 2010), the elaboration of pharmaceutical companies in the pharmaceutical equipment, installation, use, maintenance and other aspects of the specification, which are earlier versions of GMP did not mention and the Such as the new GMP provides for the use of production equipment shall not have any adverse impact on the quality of pharmaceuticals, the production equipment surface in direct contact with drugs should be flat, smooth, easy to clean or disinfect, corrosion resistance, chemical reactions may not occur with the drugs, the adsorption drugs or to the release of substances in drugs; in terms of equipment maintenance, companies should be re-confirmed by the renovation or major maintenance equipment, to meet the requirements to be used in the production; in the regulatory aspects of the equipment, the new GMP requirements for pharmaceutical production or test equipment and instruments, should use the log record includes cleaning, maintenance and repair as well as date, time, production and test the name of the drug, specifications and batch number.
High requirements of the new GMP is a challenge for small and medium-sized pharmaceutical companies. The majority of small and medium-sized enterprises, in order to save the cost of doing business, and expand corporate profits in the pharmaceutical equipment under the energy is minimal. A number of pharmaceutical companies in the procurement of equipment and carefully selected; a number of pharmaceutical companies to routine maintenance, resulting in the lack of pharmaceutical equipment, pharmaceutical equipment, production efficiency is becoming less and less decline in product quality. The above phenomenon also explains the transformation of space for small and medium-sized pharmaceutical enterprises in China is the largest. Data show that China currently has 4500 more than small and medium-sized pharmaceutical companies, if you want to meet the GMP requirements, these enterprises to update equipment spending will reach 10 million yuan, or even a billion dollars.
Pharmaceutical equipment companies want to seize the business opportunities in three areas to improve. First, pharmaceutical and equipment companies should improve product quality, strengthen the supervision of raw materials, manufacturing processes, and strictly control the quality.
The product quality is the protection of pharmaceutical equipment business survival, the low price of high quality pharmaceutical equipment will not only meet the GMP standard, but also more competitive than foreign pharmaceutical equipment. Second, pharmaceutical and equipment companies should carefully study the new version of the GMP, through research to find new business opportunities where. Some pharmaceutical companies have not carefully studied the new version of the GMP, the first to introduce the new version of the GMP, the pharmaceutical needs of the pharmaceutical equipment, it would arouse the attention of some pharmaceutical companies, which will not only allow faster than other companies occupy more markets, access to economic benefits, also won social benefits. Third, pharmaceutical and equipment companies should increase access to the Offer, to keep abreast of the equipment needs of the pharmaceutical companies to meet market needs, identify target customers, will allow enterprises to customer needs, adding more elements in the process of manufacturing equipment. Do this three pharmaceutical equipment companies, will rapidly become the dark horse in the industry and lead the market.
