Medical network on December 30 - how shocked the industry gingko fluid events were dug up? The horrible drug clinical data verification who storm in specific equipment? Who haunt drug firms flight check in?
Enterprise was afraid of this group, called the "drug inspector". Now, this group is bigger:
Yesterday, the CFDA drug inspector certificate awarding ceremony held in Beijing, a total of 609 people won the "national drug inspectors" certificate. In fact they are ordinary people "eyes", is to help people to supervise drug firms, they will start from the clinical research and development, to all the production, circulation, use and monitoring.
Jingquan send national inspector certificate
And, more importantly, this year on December 6, launched the CFDA run double random inspection module. The so-called double random, is to examine the object is random, the inspector is random, it is quite heavy, and the state council, which can make enterprise more difficult to "cope".
▍ check, find out a lot of problems
According to the CFDA food and drug audit inspection center published the drug inspection report "for 2015, 2015 to complete all kinds of drug inspection situation is as follows:
In last year sent 49 group flight check, were examined 59 companies, took measures against 37 companies, including 22 home foreclosures drug GMP certificate, six drug production licenses have been revoked, three is a case for investigation. It is clear that fly check of power.
Inspection report has not been officially announced in 2016, outdoor posters publicity material, but according to meeting the CFDA in drug clinical data verification, as of December 27, sent 114 team this year, 938, completed 197 varieties, involving the clinical data of 451 institutions for verification. Medical device clinical verification, this year also sent 10 inspection group, 41 people, 20 varieties complete, related to the clinical data of 39 institutions for verification.
The data appears to be increased a lot than in 2015.
▍ this batch of inspector very capable
649 inspectors, it is understood that this is the CFDA since 2015 began to recruit, train, it was revealed that it was eliminated after nearly 50% personnel to stay, is a group of person with ability and responsibility.
CFDA jingquan, director of the speech at the meeting, ask everybody inspector, insist the principle, impartial, dare to face difficult problems, dare to break the rules. Should have the ability to judge right and wrong, found that the problem of ability, audit of the major ability, the ability of research methods, the purpose is to find problems, eliminate hidden dangers, punishment to implement specific personnel head, power is enough. Must be able to write teaching materials at the same time, will train an apprentice, bring out more inspectors.
Jingquan speech
If you still think the inspector to deal with, that you really wrong.
After training, the inspectors, generally with the medical professional knowledge, familiar with basic computer knowledge, at the same time check can view drug firms in production and management of computer systems. They also understand the basic knowledge of finance and law, basic manufacturing costs of medicines have cognitive, too low price may will be focused on; Inspects the legal procedures and effective evidence.
Blue in the meeting feel parker, bi jingquan drug inspectors have attached great importance to the country, has made a lot of hope.
After the meeting, we also with four outstanding inspectors had a face-to-face communication. Jingquan director, they say, don't want inspectors office everyday, it doesn't make sense. I hope everyone to the enterprise inspection, found the problem, eliminate hidden dangers. In order to do a good job, they is in check, an estimated 80% of the working day of the year every check is for several days.
The inspector oath
▍ inspector how to check?
It is understood that before inspection, the inspector will often ready to elaborate, including varieties, to the enterprise personnel, workshop, the range of permission, certification information sampling situation, ever recorded, and write a check; After into the factory, often want to meet first, to the enterprise specification to check, and please cooperate with.
Then, step by step, to check during the inspection found clues at any time, by way of hildesheim and questioning, dig out more might be hidden problem, and make records, after the check, began to write a report, list what is the general defects, which are the main defects, at the same time make a feedback to companies, whether the rectification, even put on record.
At last year's "ginkgo liquid event" and "calf incident", the inspector found the problem, and tracking down step by step, finally stressed the contribution. The result is "gingko fluid incident" has four revoked the pharmaceutical production license, 47 be fined to wait for administration to punish, FaMeiKuan total amount is 103 million yuan; Eight drug firms too crime was transferred to public security organs, the seven people was sentenced to ten years qualifications punishment shall not be engaged in drug production and business operation.
"The calf blood" events affected 11 companies, there are seven listed companies, are subject to the corresponding punishment. Visible, the enterprise did not according to the production, management norms, problems in the check up, consequence is very serious.
In the future, national inspector will only increase, not decrease, while local inspectors will be multiplied. Inspectors are already on the road, the enterprise also dare to fool around? |
