Medical network - on February 9, on February 8, published by the state food administration of drug safety "back in 2016, the national drug GMP certificate of statistics".
According to statistics, in the past 2016 years, the national total of 162 drug firms 162 GMP certificate be retrieved, some drug companies have been paid more than one. In addition, this value to 2015 there were 140 drug firms 144 GMP certificate be retrieved, has the obvious improvement, visible to the agency for supervision in the field of pharmaceutical production is becoming more and more big.
Attached: the provinces take drug GMP certificate in 2016
(source: CFDA)
▍ 2016 card echelon "big five"
On the reclaim GMP "report card", the provinces is not the same. According to statistics, jilin, anhui provinces has been ranked the top three for three consecutive years, may be GMP card first echelon.
The first echelon, jilin, anhui two provinces, for three consecutive years ranked top three, 2016 card number more than 20;
The second tier: the three provinces of hebei, guangxi, hubei, collect the number of more than ten copies, hebei, in particular, can make a determined effort, 2015 1, zhang power is suddenly back 15, 2016;
The third echelon: guangdong, liaoning, shandong, heilongjiang, henan, hunan, jiangxi, shaanxi, xinjiang, hainan, 11 in gansu province, 2016 card number in the 4-9;
Tier 4: Beijing, fujian, sichuan, shanxi, Inner Mongolia, yunnan, tianjin, Shanghai, zhejiang, jiangsu, chongqing, guizhou 12 provinces, 2016 pass 1-3);
Tier 5: Tibet, qinghai, ningxia province 3, also known as zero, uncollected certificate in 2016, Tibet for three consecutive years of outstanding certificates.
▍ fly check outlook in 2017
We analyzed in the past 2016 years in front of the fly of the provinces, and the specific charge card, so, what makes the flight inspection group on your business?
According to September 1, 2015 implementation of the pharmaceutical medical instrument flight check way ", one of the following circumstances, the food and drug supervision and administration department may conduct drug medical instrument flight check:
1, complaints to report or other source of clues to show possible quality safety risk;
2, inspection found quality safety risk;
3, adverse drug reactions or medical device adverse event monitoring possible quality safety risk;
4, have some doubts about declaration data authenticity;
5, suspected of a serious breach of the quality control standard requirements;
6, the enterprise has serious record does not keep your words;
7, the need for other flight check.
Passing 18-wheeler, recently, Shanxi Province, anhui province food and drug administration issued 2017 drug GMP tracking flight check, work plan, two provinces at least 78 drug firms have been inspectors on the fly.
Shanxi Province food drug administration random lottery, to determine the drug GMP tracking check the list of 25 pharmaceutical production enterprise; While in anhui province selects three kinds of key inspection enterprise, respectively is:
1. Biological products and blood products, injection and drug price cost down in pharmaceutical production enterprise;
2. Risk rating was rated as high risk level of pharmaceutical production enterprise;
3. The drug GMP certification examination after the warning letter and defect project more pharmaceutical production enterprise.
More than just two provinces released 2017 inspection plan, then the provinces in the real fun starts. Fly in the inspection, who has a chance to be checked, be closed, even be knocked down!!! In the future, legal compliance is drug firms survival. You can be, guess and check large forces are already on the way to check your company! |
