Fosun Pharma (600 196), another "Changchun Changsheng Bio" reported by employees, released relevant instructions as scheduled last night, explaining that its company was found to have illegally produced drugs and fabricated production records and inspection records.
The report door of Fosun Pharma, which attracted media attention, originated from a report message released by the public mailbox of the US Food and Drug Administration in Chongqing on August 24th. Employees of chongqing medical Institute of Technology reported that chongqing medical Institute of Technology Pharmaceutical Co., Ltd. (hereinafter referred to as "chongqing medical Institute of Technology Pharmaceutical Company") violated the national regulations on drug production management, which was even worse than Changchun Changsheng Bio.
The internal staff reported that the company's production quality management in recent years was very chaotic, and the leaders ignored the regulations on drug production management and took the lead in fraud.
For example, the employee pointed out that "almost all production processes are not produced according to the approved process", "leading and leading employees to fabricate a large number of production records and inspection records" and "deceiving the superior drug supervision and administration department and defrauding the drug GMP certificate".
The open letter also revealed that, taking aripiprazole, a product mainly supplied to Chinese and Western medicine in Shanghai, as an example, its process was not produced according to the process approved by the state, but seriously violated the on-site inspection of FDA 20171. "In order to deliver the goods and deal with the second inspection, the leaders asked to reduce the integral area of the atlas and manipulate the products to leave the factory."
In addition, the open letter also revealed that during the relocation period, chongqing medical Institute of Technology used the old technology to fabricate complete sets of production and inspection records in the process of applying for site transfer and GMP certificate from Chongqing US Food and Drug Administration because the actual production technology was inconsistent with the approved technology, thus deceiving superior departments and inspectors. At the same time, the employee also said that "due to fraud and other reasons", the company was inspected by the US FDA in May of 201June of 201KLOC-0/July, and received a "warning letter" and a "worst evaluation result (OVI)" respectively.
On the evening of August 30th, Fosun Pharma made a special announcement on the contents of the report letter, saying that the US Food and Drug Administration of Chongqing had conducted a flight inspection on Chongqing Pharmaceutical Industry Research Institute Co., Ltd. (referred to as "Chongqing Medical Engineering Institute") on October 20th/KLOC-8th, and the inspection results were still to be determined.
According to the information released by Fosun Pharma and official website of chongqing medical Institute of Technology, the pharmaceutical company declared by chongqing medical Institute of Technology is 70.37% owned by chongqing medical Institute of Technology, and another shareholder, CDB Development Fund, holds 29.63%. Chongqing medical Institute of Technology, founded in 1950, was the only professional R&D institution in southwest China at that time. In 200 1 year, as the first batch of scientific research institutes in Chongqing, Shanghai Fosun Pharmaceutical Industry Development Co., Ltd. and Chongqing Pharmaceutical (Group) Co., Ltd. jointly established Chongqing Pharmaceutical Industry Research Institute Co., Ltd. (now chongqing medical Institute of Technology). At present, Fosun Pharma holds 56.89% of the shares of chongqing medical Institute of Technology as the controlling shareholder. It is reported that chongqing medical Institute of Technology and chongqing medical Institute of Technology are mainly engaged in the research and development, production and sales of raw materials and intermediates of generic drugs, and their main customers are pharmaceutical companies in Europe, America and China.
In 20 17, Chongqing medical engineering institute (consolidated caliber) realized an operating income of 77.8 million yuan, accounting for 0.42% of Fosun Pharma's operating income in 20 17; The net profit attributable to the parent company is-34,665,438 yuan+0,000 yuan.
Among them, overseas sales revenue accounts for about 26%.
Fosun Pharma specifically states as follows:
1 and 20 16 years, the FDA of the United States inspected the factory of chongqing medical Institute of Technology, issued a warning letter and put forward rectification requirements for the problem of irregular laboratory data. Fosun Pharma said that according to the rectification requirements, the main leaders and relevant responsible persons of Chongqing Medical Engineering College at that time have been seriously dealt with and adjusted, and relevant rectification work is being actively promoted.
2.20 17, 1 1, the FDA of the United States conducted a pre-approval inspection on the drug quality system of the School of Medical Engineering. After the inspection, 483 defects were put forward for aripiprazole, mainly aiming at the deficiency of OOS (deviation investigation) in aripiprazole detection. At present, the pharmaceutical industry of the Institute of Medical Engineering has been rectified under the guidance of FDA.
3. According to the self-examination of Pharmacy Department of Medical Engineering College, the existing products are produced according to the approved process. In the process of production, the adjustment of production technology is approved or put on record by the relevant drug supervision department.
On April 2016, chongqing medical institute of technology transferred the product approval of aripiprazole and pemetrexed disodium to its pharmacy, and on October 20 18, the product approval of iron sucrose was transferred, which has passed the on-site inspection and approval by the drug supervision department.
5. Aripiprazole, the pharmaceutical raw material of Medical Engineering Research Institute, is currently applying for process change, and the products provided to Shanghai Xi Zhong Sanwei Pharmaceutical Co., Ltd. on 20 18 are only used for its preparation research.
6. The US Food and Drug Administration in Chongqing has made relevant investigations on the contents reflected in this letter, and conducted a flight inspection on chongqing medical Institute of Technology on August 23rd, 2065438. The results of the flight inspection are still to be determined.
Source:? Southern Metropolis Daily (Shenzhen)