On September 21st, our company ushered in the first flight inspection after the GMP re-certification in May. The first inspection was Jinhua Drug Certification and Inspection Center, accompanied by Dongyang City Market Supervision Administration, company general manager Tang Zhaohui, deputy general manager Zhou Wei, Li Yubo and quality director Guo Qixin.
In accordance with the requirements of the inspection program, the inspection team conducted a comprehensive inspection of the three departments of our company's infusion workshop, laboratory and warehouse. Mainly involved in product technology, batch production records, deviations, changes, inspection of raw data. As far as the overall situation of the inspection is concerned, the inspection results are relatively smooth. For some minor defects found, the relevant departments also issued a rectification plan in a timely manner.
This year, with the implementation of the two-vote system and the impact of the Changchun vaccine incident on the entire pharmaceutical industry in August, the State Food and Drug Administration and relevant local authorities have significantly increased the supervision of some high-risk enterprises, and the normal inspection of the pharmaceutical industry. Increased.
Faced with the various inspections and rectifications that are becoming more and more high-pressure, pharmaceutical manufacturers must conscientiously do a good job in each self-inspection by improving the software and hardware management level, so that they can adapt to the normal inspection and take the flight inspection. In the case of as much as possible, continue to strengthen the fine-grained on-site management, and eliminate the problem from the source. In addition, we must further strengthen employee training, improve execution and coping, formulate rectification targets for various problems, and form a strong benign PDCA cycle.