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“We encourage companies to go ahead of the industry, especially in industrial development. Past experience has repeatedly verified that companies often go before the industry standards.†said one industry right person. I believe that in the future in the transformation of the new version of GMP, domestic pharmaceutical equipment will occupy an increasingly mainstream position. The development of China's pharmaceutical industry will get better and better, and it will go healthier.
In the new GMP reform, not only pharmaceutical companies have grown up, domestic equipment companies have emerged as much as the superiority of foreign imported equipment, and encourage companies to go ahead of industry regulations, which is also a precedent in FDA regulation. He thinks this kind of sign is very worthy of recognition.
At present, industrial design is a common weak link in the industry. It is the main difference between developed enterprises in China and Europe and the United States. It is also a key technology for the domestic industry to be promoted. Only by thoroughly understanding and mastering the design of industrial systems can we quickly upgrade our industry. It is the only way for industrial progress, and it is also the only way to fundamentally solve the backwardness of China's industries. In fact, a number of high-quality domestically-manufactured equipment are still appearing in the new GMP reform that has passed the certification.
In order to save unnecessary capital wastage, a medical device company in Shandong has already carried out computer simulation of risk points, and then asked experts to “consult†to give opinions and become a commonly used means of designing new GMP projects. This method is far better than the reality of the module program to do a full validation and transformation, to save money and time investment, and this means of scientific innovation has also been generally welcomed by corporate customers.
In the reform of the new version of GMP, domestic pharmaceutical equipment will occupy an increasingly mainstream position. More and more high-quality domestically produced pharmaceutical equipment with independent intellectual property rights will emerge in the upgrading of technological equipment in the pharmaceutical industry. Enterprises that fail to pass the certification will not be able to guarantee supply through certification in the short term, but will be eliminated by the market. The inevitable outcome.
Enterprises that fail GMP certification will be eliminated by the market
In December, the new version of GMP certification for aseptic drug manufacturers entered the countdown period of days, and listed companies that produce sterile products such as blood products, vaccines, and injections will stop production if they fail to pass the new GMP certification. It is understood that by the end of the year, there will be a considerable number of sterile pharmaceutical companies forced to stop production.