One, what is veterinary drug GSP certification? GSP Good Supplying Practice is the English abbreviation, literal translation for the good of the drug supply specification, in China called the" drug quality management

One, what is veterinary drug GSP certification?

GSP Good Supplying Practice is the English abbreviation, literal translation for the good of the drug supply specification, in China called the" drug operation quality management rules". It is refers in the drug circulation process, according to purchasing plan, purchase acceptance, storage, sales and after sale service and other links and make to ensure drug quality a management system. Its core is constrained by the strict management system enterprise behavior, drug products of the whole process of quality control, ensure to provide users with high-quality drugs. In the veterinary drug industry," the veterinary drug operation quality management rules" is referred to as a veterinary drug GSP, for veterinary drug enterprises to provide a scientific quality management system, make animal drug management of the ideological and organizational structure has undergone fundamental changes, is China's veterinary drug enterprises to participate in market competition the prerequisite.

Veterinary drug G S P is a veterinary drug operation quality management basic principle, is to strengthen the management of veterinary drugs, veterinary drug operation quality assurance quality and develop a set of management system. Veterinary drug GSP implementation marks the government departments in charge of the veterinary drug production to adopt mandatory standard ( GMP ), began to veterinary medicine circulation field remediation. Veterinary drug operation link bearing manufacturers, even under the breeding base, for purifying veterinary medicine market, ensure the quality of veterinary medicinal products plays an irreplaceable role in. Therefore, the veterinary drug GSP implementation not only on the domestic 7 000 veterinary drug enterprise life and death, but also for the veterinary drug producers and users are highly concerned about the.

Veterinary drug GSP certification is this year the management of veterinary working Chongzhongzhi is heavy. Veterinary drug GSP certification is the state of pharmaceutical enterprises management of drug quality supervision and inspection for a means to carry out animal drug GSP, the purpose is to improve the qualified rate of operating part of veterinary drugs, animal health and human security protection. It requires the veterinary drug enterprises operating in the process of veterinary drugs, contract, purchase, acceptance, storage, sale, transportation and after sale service link, the implementation of a comprehensive, scientific, standardized management, to ensure the quality of veterinary drugs operation. Through the promotion of veterinary drug enterprises veterinary drug GSP acceptance standards, the full implementation of veterinary drug enterprise standardization management, strive for new a batch of good management, system, large scale, service excellent large-scale veterinary drug enterprises, ban those chaotic management, system is not whole, small scale, low quality of personnel of small veterinary drug enterprises.

Two veterinary drug GSP certification of unfavorable factors, you know?

Management enterprise must in accordance with the provisions of animal drug GSP self evaluation, self assessment after clearance to the veterinary administrative departments for veterinary administrative department, initially through the audit, to apply enterprise site acceptance review.

" According to the WHO certification, who review principle, general medicine business enterprise from each county city to organize examination."

Guangdong Jiangmen approximately seven hundred or eight hundred veterinary drug management main body. Look from actual condition, 60% - 70% of the enterprises will apply for certification, that is to say there will be about 500 enterprises in the future will be a year of many time to receive certification. However, Jiangmen's 5 counties, only selection of more than 20 veterinary drug GSP certification inspectors, each inspection team in about a year certification in 100 enterprises.

So the workload is not easy. In accordance with the Ministry of agriculture on veterinary drug GSP inspection requirements, inspection personnel in addition to inspect the enterprise hardware, such as warehouse area, refrigerator (cabinet) and other related facilities, equipment, but also understand the business of veterinary drugs; in software, check the quality management, invoicing, staff training and a series of rules and regulations, as well as the operating personnel qualifications, business license, computer operation ability and so on. The current township veterinary medicine shop many are" shop", business quality is not high, if strictly implement the relevant examination, review rate that is not too low.

According to estimates, each enterprise from trial to inspect the need about half to one day time. According to the inspection company took 0.75 days, veterinary drug GSP certification will take 75 working days, total working days ( 250 days) of nearly 1 / 3.

More worryingly, currently responsible for veterinary drug GSP certification inspector, from the vet, animal protection and other functions of the Department of. They are not full-time inspectors, usually with all kinds of daily work and special activities. So, remove the SOHO upgrade for enterprises as well as the inspector routine and special activities, for veterinary drug GSP certification time will be more tense.

In fact, effects of veterinary drug GSP certification adverse factors is far more than these. The inspector general report, in addition to manpower shortage, the enthusiasm to safeguard the problem is. Veterinary drug GSP certification is the basis of the existing research of increment, this part of work assessment, with or without supporting office funds and so on are be in suspense. And township veterinary drug stores located mostly scattered, particularly in the mountain town, traffic is very inconvenient, if there is no corresponding subsidies or transport infrastructure, will not only affect the efficiency of authentication, but also against the inspector 's work enthusiasm.