Requirements for Pharmaceutical Equipment Production will be Stricter in the Future with the Upgradi

According to the Guiding Opinions on Further Improving Work of Food and Drug Standards (hereinafter referred to as the Opinions) issued by China Food and Drug Administration (CFDA) recently, 3,050 Chinese national pharmaceutical product standards and 500 medical device standards will be formulated or modified by 2020. According to the analysis of an insider, the objective means that China will accelerate the process of assuring pharmaceutical product safety, and upgrade pharmaceutical product standards to be more perfect and stricter.

Pharmaceutical product safety has long been the focus of the society, which does not only involve major livelihood and public security issues, but also relates to the people’s health and society’s harmony and stability. The introduction of the Opinions will promote the standardized, normalized, and scientific development of the pharmaceutical industry in China, and formulate and raise stricter standards and requirements to the pharmaceutical equipment industry.

The role the pharmaceutical equipment plays in the pharmaceutical industry speaks for itself: it is the equipment in intimate contact with pharmaceutical products, and stands for a key link in the pharmaceutical production. In fact, pharmaceutical equipment assumes heavy responsibilities at present when pharmaceutical product safety receives great attention and the industry standards are being gradually improved and stricter. Therefore, it is necessary for pharmaceutical machinery enterprises to put more effort in production, innovation, and R&D of the pharmaceutical equipment.

In terms of assuring pharmaceutical product safety, the Opinions proposes that ideas of pharmaceutical product quality from design and controlling and assuring production throughout the process shall be reflected. Take the process design of aseptic preparation plant for instance, asepsis and cleanliness are the most stressed idea for aseptic preparations, and many pharmaceutical enterprises are cautious in selecting the aseptic preparation production equipment.

More specifically, the pharmaceutical equipment needed by aseptic preparations shall have simple structure and bright and clean surface, and shall be easy to clean, and resistant to disinfection and corrosion. The experts have advised that the pharmaceutical equipment for aseptic pharmaceutical products shall use the quality low-carbon stainless steel, and the selection of the main production equipment shall give priority to the advanced and mature equipment in China and foreign countries. From this perspective, the production of such equipment seems to be not complicated, but in fact, the requirements for the equipment quality and technology are quite high.

Furthermore, the Opinions also proposes improving the scientific and technological innovation capacity of the medical device standards, and guiding the development of high-tech products, to accelerate reaching the international level. According to relevant experts, the investment prospects in the pharmaceutical equipment industry of China are in fact very broad, and with the issuance of the Opinions on Deepening the Reform of the Review and Approval System and Inspiring Innovation of Drugs and Medical Devices and the formation of the pharmaceutical product and medical device innovation system, the Chinese pharmaceutical equipment industry will make innovation the direction, to thus achieve the objective of developing innovative, safe, and high-tech pharmaceutical equipment.

To assure the drug safety of the people, some pharmaceutical machinery enterprises have integrated innovative ideas in the R&D of pharmaceutical equipment by utilizing advanced production technology and starting with details. Take the laser marking machines that are widely applied in pharmaceutical packaging for instance, the newly developed CO2 laser marking machine has emerged on the market in recent years, which applies the laser marking technology that features cleanliness, to not only guarantee the cleanliness of the pharmaceutical packaging production environment, but also eliminate the material consumption problem. Besides, the CO2 laser marking machine has also satisfied users’ desire for high-speed marking equipment, which can complete marking rapidly and even complete marking of complex structures.

However, the current development of the laser marking machine industry in China has not completely reached the international level. Chinese pharmaceutical machinery enterprises, to truly innovate in terms of pharmaceutical equipment technology, further get rid of weaknesses in industry development, and fill in technological gaps, still need to go abroad, integrate global resources, and strive for better technical resources through cooperation, M&A, or other powerful ways, to thus add brilliance to themselves and the industry future.

Overall, the pharmaceutical product standards are becoming increasingly improved and increasingly higher, and pharmaceutical machinery enterprises shall do everything they can to accomplish good quality production, regulation and control, and innovation and R&D, so as to meet the high requirements and high standards, and protect the life safety of the people. Only in this way can the Chinese pharmaceutical industry have more peace of mind and confidence on the development road.

Source: www.zyzhan.com

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