One drug company was accepted GMP, 3 drug companies were received GSP!

Yesterday (June 27th), another pharmaceutical company received another GMP. At the same time, 3 drug companies were received GSP.

A pharmaceutical company was accepted GMP

Yesterday (June 27th), the Shanghai Food and Drug Administration issued the Notice of Recall of GMP Certificate for Drugs (No. 2 of 2016). Shanghai Qingping Pharmaceutical Co., Ltd. was withdrawn from the GMP certificate for tablets, which is also this year. Shanghai took back the second GMP certificate.

It is understood that Shanghai Qingping Pharmaceutical Co., Ltd. is one of the inspection reports issued by the General Administration of Food and Drug Administration on the night of June 7 against four pharmaceutical companies. The other three companies are Chongqing Greiling Pharmaceutical Co., Ltd. and Baiyun Shandong. Tai Shangqiu Pharmaceutical, Datong Yungang Pharmaceutical Co., Ltd. According to the inspection report of the State Bureau, Chongqing Greining Pharmaceutical Co., Ltd. has been reclaimed the GMP certificate by Chongqing Food and Drug Administration, and for the remaining three drug companies, the State Bureau requires the provincial drug regulatory agency where the pharmaceutical company is located to recover its GMP certificate. .

From the time of resuming the GMP certificate, after the Shanghai Food and Drug Administration released the Shanghai Qingping Pharmaceutical Co., Ltd. on June 27, the GMP certificates of the above four pharmaceutical companies were all recovered.

According to the "Report on Follow-up Inspection of Shanghai Qingping Pharmaceutical Co., Ltd." previously published by the State Bureau, Shanghai Qingping Pharmaceutical Co., Ltd. has the following major problems in the follow-up inspection of GMP:

I. Problems with reliability of laboratory data

1. Find traces of modified inspection dates in the experiment log of Shimadzu LC-10AT:

1After October 11, 2015, there was a record of the inspection of records of the stability of demibarazole (batch number: 1309-3, 1109-1, 1209-8, 1209-9, 1209-10) on September 29, 2015. ;

2After December 17, 2015, there was an examination record of the accuracy and durability of the raw maternal tablets on April 16, 2015.

2. There is a pattern deletion in Shimadzu LC-20AT, and the reason is not explained, including:

1 Demiazole (batch number: 1406-1) No. 15 and 16 maps under the relevant substance inspection item were deleted;

2 In the verification of the production of solid preparation equipment for production of propafenone hydrochloride as a marker, four maps were removed from the system suitability test on June 16, 2015.

Second, there are insufficient measures to control pollution and cross-contamination in the production process of enterprises.

For example, the collecting bag used for smashing raw and auxiliary materials has no obvious mark, which can easily result in cross-contamination among different varieties; the rooms that are easy to produce dust, such as weighing, smashing, granulating, drying, total mixing, and pressing, are not provided with an antechamber. And there is no effective dust-catching measures in the function room; the V-type mixer's cleaning procedure (SC-SOP-0304-007) requires no specific, lack of maneuverability; pulverizer, V-type mixer, and upper and lower materials for transferring materials. The interface, etc. are not completely clean and all have white powder residue.

3 drug dealers received GSP

Yesterday (June 27th), Fujian Food and Drug Administration issued an announcement to recover the three pharmaceutical wholesale companies Xiamen Xinyang Pharmaceutical Co., Ltd., Xiamen Renxintang Pharmaceutical Co., Ltd., and Fujian Guoling Pharmaceutical Co., Ltd. GSP certificate.

According to the provisions of Article 25 of the "Administrative Measures for the Administration of Pharmaceutical Business Quality Management Standards" and the "Medicine Equipment Flight Inspection Measures," three drug wholesale companies such as Xiamen Xinyang Pharmaceutical Co., Ltd. have seriously violated the "Pharmaceutical Business Quality Management Regulations." ” (No. 13 of the Directorate-General's Bureau) relevant regulations, the Bureau to take legal measures to recover the risk control measures of the “Pharmaceutical Business Quality Management Specification Certification” of 3 pharmaceutical wholesale enterprises such as Xiamen Xinshenyang Pharmaceutical Co., Ltd.

Under high-frequency inspection, drug companies and drug dealers are getting harder and harder!

For drug GMP inspections by the drug regulatory agency, the high frequency and strictness need not be mentioned. Since this year, a series of flight inspections and follow-up inspection announcements by the State and provincial food and drug administrations have been reflected.

Starting from January 1, 2016, the State Bureau will no longer undertake GMP certification inspection tasks. All GMP certification inspections will be undertaken by the provinces. The GMP certification inspection tasks in the province will be further increased, and the frequency of inspections will also be greatly increased. .

Earlier, the National Bureau said that it will establish a full-time inspector team and specialize in inspections. Unexpectedly, so far, two batches of 649 national GMP inspectors have been announced. At this rate, that is to say, the third batch, the fourth batch... The Nth batch is also ready to go! Together with the GMP inspectors of drug regulatory agencies in various provinces and cities, it can be said that a large number of GMP inspectors are already on the flight inspection and follow-up inspections.

For pharmacists, since September 1, 2015, many drug dealers have relied on guns or voluntarily withdrew in large-scale “cleaning campaigns” after the official implementation of the “Medicine Medical Device Flight Inspection Methods”, which has caused countless drug dealers to talk about changes in color. .

After the State Food and Drug Administration issued the "Notice on the Reorganization of Illegal Business Conduct in the Circulation of Drugs (No. 94 of 2016)" on May 3, the provinces have successively carried out rectification actions for drug distribution companies, and they have issued "certificates and tickets for drug dealers." , accounts, goods, money "large-scale focus inspection.

Nowadays, regardless of whether it is a drug manufacturing company or a business enterprise, the state is increasingly strict in its supervision. Those pharmaceutical companies and drug dealers that have successfully passed the GMP and GSP certification must not take it lightly. In the future, for those companies that have passed GMP or GSP and are otherwise unlucky, they will lose ground in various flight inspections and follow-up inspections.