Pharmaceutical equipment quality and safety market access should be implemented - the pharmaceutical, equipment, medicine machine - pharmaceutical

Authoritative data, the current pharmaceutical equipment industry in China nearly a thousand, about 15 billion yuan in output value, regardless of yield, product specs and number of businesses have been ranked first in the world. China has become the largest producer of pharmaceutical equipment.

Status, but with the producing countries do not match, the current pharmaceutical equipment production in China is not strong. Low level of production technology, product sampling compliance rate was low, despite repeated prohibition of fake and shoddy products, pharmaceutical and equipment companies cheap, low-level competition seriously affected the export credit, etc., is holding a Chinese power forward to the pharmaceutical equipment, the pace of production.

On how to better address the problems of troubled industry, China Pharmaceutical Equipment Industry Association, azurite, Vice Director of direct measures. She called on pharmaceutical equipment quality and safety market access system for urgent establishment, which is the actual situation of our country, in order to ensure quality and safety of drugs is important and should take the necessary measures.

Azurite analysis pointed out, the pharmaceutical and equipment quality safety market access system is equipped with standard pharmaceutical market, improve the quality of drug production and ensure the safety of consumers health, to promote the healthy development. Drugs is a special commodity, the most directly related to the whole of society and every family, every consumer's health and safety. In recent years, the people's living standards rising at the same time, Drug Quality Security has become increasingly prominent. To ensure the quality of medicines, pharmaceutical equipment, pharmaceutical technology to meet the requirements of key control equipment is also extremely important. Drug production and processing from the source to ensure drug safety, must develop a line of the socialist market economy, are operating effectively, in line with international practice, pharmaceutical quality and safety control system equipment.

Azurite that the pharmaceutical drug production equipment is one of the sources of pollution. "Drug Law" stipulates that pharmaceutical manufacturers must pass "Drug Manufacturing Practice" requirements, the implementation of pharmaceutical equipment quality and safety market access system is to ensure the quality of the basic conditions for drug production, drug production is to strengthen the legal management needs. Currently most of China's pharmaceutical manufacturing plant and equipment are small and medium enterprises, the overall design, manufacturing capacity is not strong, and some pharmaceutical products and equipment manufacturers do not have the inspection capacity. Some business management is not standardized, do not follow the standard to organize production. Enterprise is to ensure and improve product quality, subject, in order to ensure quality and safety of pharmaceutical production, pharmaceutical production equipment to strengthen the link quality and the environment supervision and management of the production equipment from Seizing market access conditions.

Foreign experience shows that the pharmaceutical quality and safety market access system equipment is to ensure the quality and safety of drug production, the producers have the required equipment, the conditions allowed for production and business activities, have the required conditions allowed the production of pharmaceutical equipment sales monitoring system. Therefore, it should be a government activity, is an administrative permit system.

This connection, azurite recommended, pharmaceutical equipment, quality and safety market access system should include three specific systems:

First, the pharmaceutical equipment manufacturers to implement the production permit system. To have basic production conditions, to guarantee quality and safety of pharmaceutical production companies, release "pharmaceutical equipment production license", within the allowed production of the certified products; not obtained "pharmaceutical equipment production license", the company closed production system medicine and equipment. This is from the production conditions to ensure the company can produce products that meet quality and safety requirements.

2 is a production of pharmaceutical equipment mandatory inspection system. Failure without inspection or testing the factory are not allowed to sell pharmaceutical equipment. Do not have the self-test conditions for the production company to compel the implementation of commissioning tests. This requirement for Chinese enterprises existing production conditions and management can effectively guard the checkpoint of the quality products manufactured safety.

Third, the implementation of a licensing system for pharmaceutical products and equipment to implement the market access labeling system. Qualified on the test equipment to the pharmaceutical printing (paste) market access QS mark, no sign of the pharmaceutical equipment affixed QS permitted to enter the market. Doing so, facilitate the identification and monitoring of consumers, the administrative law enforcement departments to facilitate supervision and inspection, also help to promote the drug manufacturers to improve quality and safety responsibilities.

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