Once the company get GMP and awarded a certificate, it will manufacture. In the past drug manufacturing enterprise try their best to prepare, upgrade equipment, train staff and prepare material before authentication. Once they get approval, some company will return to manufacture nonstandard.

    Normalization of flight check changes this situation. Since this year Shandong province pursue efforts on flight check in pharmaceutical production field. The inspectors do not send notification, do not give message, do not accept report, do not need companion and reception. They go straight to basic level and scene to check. SFDA organized 24 inspection teams to check 41 drug manufacturing enterprises yearly.Thereinto, 12 of them was took back GMP. 7 of them was under investigation due to alleged violation. 18 of them was ordered to make rectification.

    Drugs circulation links was brought into flight check this year. Until now, There are more than 2,000 drug manufacturing enterprises accepted flight check in our province. 38 of them  have been revoked the GMP. 121 of them was withdrew the GMP. More than hundred companies was under questioning and rectification.

“Big envelope”to ensure the surprise

    Why does the flight check can strike accurately? Li linbo who is deputy director general of SFDA marketing consider that the key point of flight check is surprise so that the company is difficult to prepare and the inspectors can direct strike the truest of daily production.

This June a pharmaceutical wholesaler accept inspections. The inspectors found a place showed “TCM tablet, deliver area of TCM”. But that place is not registered warehouse area. Inspectors found they privately set up warehouse. Li linbo said that temperature and humidity need to control strictly for drug storage. The operating cost of warehouse is high, so some companies use simple warehouse to store drugs to decrease cost. Li Linbo told that it is very difficult to find that condition, but this year they found many illegal warehouse through flight check.

    Drug regulatory department introduce stringent “big letter”to protect its measures to make every flight check to be surprise. Before flight check, the information of checked companies is locked in a big letter. Nobody knows what inside. The group leader will open that letter under group members and confirm the checked companies. Then the check panel will call a observer to follow which is from CFDA.

Extrude “small, scattered and weak”

    Why the flight check can give much more pressure on companies? The flight check can control the point of drug companies. Once confiscate the license, the company need to get approval again. If companies was removed the license, they can not manufacture at least half an year so it means the companies equal to dead.

Last year, a manufacturer of TCM can not manufacture because its warehouse can not meet the standard. Deputy director of CFDA named Xiao Jie said that it means dead for individual enterprise but it is metamorphosis of eliminating outdated capacity for pharmaceutical industry.

    As a big pharmaceutical province, pharmaceutical industry of our province face awkward situation. 90% of pharmaceutical enterprises are middle and small-sized enterprises. low-level repeating and low cost competition is very prominent. Regulation is weak. After innovation of food and drug,average members of front-line managers are 3.6. It severely restricted the regulatory power so enterprise is easy to take chances. Normalization of flight check can make up weakness of conventional power regulation through “capturing & grueling”.