According to authoritative data, at present, there are nearly 1,000 pharmaceutical equipment manufacturers in China with an annual production value of about 15 billion yuan. No matter what the output, product model specifications and number of companies have ranked first in the world. China has become a major producer of pharmaceutical equipment.
However, it does not match the status of a major producer. At present, China is not yet a strong producer of pharmaceutical equipment. The level of production technology is low, the qualified rate of product sampling is not high, counterfeit and shoddy products continue to be prohibited for many times, and low-cost and low-level competition of pharmaceutical equipment companies seriously affects export credibility and so on, dragging down the pace of China's move towards a strong pharmaceutical manufacturing country.
As for how to better solve various problems that plague the development of the industry, Shi Qing, vice chairman and secretary general of the China Pharmaceutical Equipment Industry Association, proposed targeted measures. She appealed that the market access system for quality and safety of pharmaceutical equipment should be established urgently. This is one of the important and necessary measures that should be taken to ensure the quality and safety of pharmaceuticals based on the actual situation in China.
Shi Qing pointed out that the implementation of the market access system for quality and safety of pharmaceutical equipment is to standardize the pharmaceutical equipment market, improve the quality of pharmaceutical production, ensure the safety and health of consumers, and promote the healthy development of the industry. Drugs are a kind of special commodity, and they are most directly related to the health and life safety of every household and every consumer in the society. In recent years, while the people’s living standards have continued to rise, the quality and safety of pharmaceuticals have also become increasingly prominent. To ensure the quality of pharmaceuticals, pharmaceutical equipment must meet the requirements of the pharmaceutical process, and control of key equipment links is also extremely important. In order to ensure the quality and safety of pharmaceuticals from the source of pharmaceutical production and processing, a set of pharmaceutical equipment quality and safety supervision systems that meet the requirements of the socialist market economy, operate effectively, and comply with international practices must be established.
Shi Qing believes that pharmaceutical equipment is one of the sources of pollution in drug production. The "Pharmaceutical Law" stipulates that pharmaceutical production enterprises must pass the requirements of the "Pharmaceutical Production Management Regulations" to implement the pharmaceutical equipment quality and safety market access system is the basic condition for ensuring the quality of drug production, and it is the need to strengthen the legal system for drug production management. At present, most of China's pharmaceutical equipment manufacturing plants are small and medium-sized enterprises. Overall, the design and manufacturing capabilities are not strong. Some pharmaceutical equipment manufacturers do not have the ability to inspect products. Some enterprise management is not standardized and does not organize production according to standards. The enterprise is the main body that guarantees and improves product quality. In order to ensure the quality and safety of drug production, it is necessary to strengthen the supervision and management of the quality and environment of the pharmaceutical production equipment link, and to shut the market access off from the conditions of the production equipment of the enterprise.
Foreign experience shows that the market access system for quality and safety of pharmaceutical equipment is to ensure the quality and safety of pharmaceutical production. Producers with the prescribed equipment conditions are allowed to carry out production and business activities, and pharmaceutical equipment with specified conditions is allowed to have a production and sales supervision system. Therefore, it should be a government act and it is an administrative licensing system.
In this connection, Shi Qing suggested that the market access system for quality assurance of pharmaceutical equipment should include three specific systems:
The first is the implementation of a production license system for pharmaceutical equipment manufacturers. For enterprises that have basic production conditions and can guarantee the safety and quality of drug production, the "Pharmaceutical Equipment Production License" is issued and products within the scope of production certification are granted; enterprises that have not obtained the "Plasma Equipment Manufacturing License" are not allowed to produce pharmaceutical equipment. This ensures from the production conditions that the company can produce products that meet the quality and safety requirements.
The second is the implementation of mandatory inspection systems for pharmaceutical equipment produced by enterprises. Unqualified or unqualified pharmaceutical equipment is not allowed to be manufactured. For companies that do not have the conditions for self-inspection, they are forced to implement commissioned inspections. This provision is suitable for the existing production conditions and management standards of Chinese enterprises, and can effectively shut down the safety and quality of the manufactured products.
The third is to implement the market access mark system for products that implement the pharmaceutical equipment production licensing system. The QS mark for market access shall be printed on the pharmaceutical equipment that has passed the inspection, and pharmaceutical equipment without the QS mark may not be allowed to enter the market for sale. In doing so, it is easy for consumers to identify and supervise and facilitate the supervision and inspection of relevant administrative law enforcement agencies. At the same time, it is also conducive to promoting the sense of responsibility of manufacturers for improving the quality and safety of pharmaceuticals.

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