On 30th June, 2017, Shanghai Desano Chemical Pharmaceutical Co., Ltd held Quality Audit Summary Meeting was at Activity Center of Employee. More than 90 staffs of company management team, production department and quality department of Shanghai Desano Pharmaceuticals Co., Ltd, Shanghai Desano Chemical Pharmaceutical Co., Ltd, Jiangsu Puxin and Yancheng Desano attended this meeting.
Mrs. Zheng Yuqing (Vice President of Desano Pharmaceuticals) introduced the joint inspection of FDA, WHO, MHRA, EMA, EDQM, TGA in March and the close-out of FDA warning letter. Through the pictures and descriptions, we reviewed the unforgettable steps and details during the response of warning letter and the self-inspection and self-correction process for joint inspection.
Mr. Zhao Haikun (Vice GM of Desano Chemical Pharmaceutical) and other 5 employees summarized the experience and learnings of the process of joint inspection and response of warning letter. In May, 2015, Desano Chemical Pharmaceutical accepted the FDA inspection. In order to submit comprehensive and accurate CAPA response, we conducted self-inspection and summited response for 5 times. In June of 2016, Desano Chemical Pharmaceutical received the FDA warning letter. Facing the suspect from industry, customers and authority, whole Desano team analyzed the problems positively and cheered up to take actions to overcome this difficulty. Desano established a self-inspection team, which consisted of more than 80 staffs from QA, QC, Production, Equipment and Utility, Logistic, HR and Calibration. In the past two years, besides the implement of CAPAs, related 788 GMP problems of production system had been reviewed and assessed for 1 year. A large number of review records, assessment reports were created. Desano quality management learned that it is critical to have the procedure to abide by, do as per the procedure, and double check after implementation. During the troubleshooting and CAPA of utility system, it is important to assure that no record was missed and no corner was ignored. Logistics depart ensured the compliance during daily operation and recorded correctly what they saw.
Ye Shilai (General Manager of Desano Chemical Pharmaceutical) summarized the close-out of FDA warning letter. He mentioned that the process of self-inspection and joint inspection was tough and unforgettable. It was not easy to achieve such success so that we should implement work task and establish the continuous improvement quality culture. It is responsibility of every staff to assure the quality. There is no destination of improvement of quality management.
Dr. Li Jinliang (President of Desano Pharmaceuticals) appreciated the efforts from teams of the third party consultant company, Desano Pharmaceuticals and Desano Chemical Pharmaceutical. He required that we should take this opportunity to accumulate experience and learnings, keep improving the quality management skill, build the core competitive advantage for development of the company.
Li Jingpeng (Chairman of Desano Pharmaceuticals) called for all the employees to keep learning, promote the continuous improvement quality culture, be dare to find and solve problems, be confident to overcome difficulties. Through keeping improvement and implementing daily work to continuously improve quality management ability.
Quality improvement has no destination. We are always on the road.
