The State Food and Drug Administration will supervise the 2022 vaccine production inspection

On September 28, 2022, Huang Guo, deputy director of the State Food and Drug Administration, led a team to Beijing Kexing Zhongwei Biotechnology Co.
, Ltd.
to supervise the 2022 vaccine production inspection work, listened to the work report of the inspection team of the verification center of the State Food and Drug Administration, and required relevant departments to do a good job in vaccine quality supervision and inspection in
an orderly and effective manner.

 

Huang Guo held discussions and exchanges with the inspection team, the Beijing Municipal Food and Drug Administration, and Beijing Kexing Zhongwei Biotechnology Co.
, Ltd.
, went deep into the workshop to observe the inspection process, and learned in detail about the progress of vaccine production inspection in 2022, the supervision of the local drug regulatory department in the factory, and the preparation of enterprises to meet the WHO pre-certification on-site inspection
.

 

Huang Guo pointed out that the Party Central Committee and the State Council attach great importance to vaccine supervision, and the State Food and Drug Administration has always regarded vaccine supervision as the top priority
of its work.
On the basis of the daily supervision and inspection carried out by the local drug regulatory departments, the State Food and Drug Administration organizes capable inspection forces to conduct annual full-coverage inspections of vaccine production enterprises nationwide every year, which builds another barrier and adds another insurance for the bottom line of vaccine source quality and safety, which fully reflects the high sense of responsibility of
drug regulatory departments at all levels for vaccine quality safety and people's life and health.

 

Huang Guo stressed that the relevant departments and bureaus of the State Food and Drug Administration, directly subordinate and territorial drug regulatory departments should strengthen organizational leadership and coordination, further coordinate the national inspection force, optimize the inspection mode, strengthen the inspection means, and complete the annual full-coverage vaccine production inspection work
with high quality and efficiency as planned.
First, it is necessary to improve the political position, use the inspection weapon to cut off the risk chain, further strengthen the technical guidance and control of enterprises, strengthen the territorial supervision responsibility of the provincial drug regulatory departments, and build a solid bottom line
for vaccine quality and safety.
Second, we must take the initiative to benchmark international standards, adhere to the investigation to promote reform, to investigate to promote construction, dynamically improve the quality management level of enterprises, promote the refined development of inspector capabilities, and improve the overall quality
of inspection.
Third, we must adhere to the problem orientation, summarize the past problems and common and personality risk signals, formulate and implement inspection plans based on the principle of risk management, and improve the accuracy and targeting of
inspection and inspection.
Fourth, we must consolidate the main responsibility of enterprises, continue to supervise and guide enterprises to implement inspection and rectification, seek truth from facts to analyze and solve problems, resolutely close hidden risks, and ensure product quality and safety
.

 

The relevant responsible persons and staff of the Drug Supervision Department of the State Food and Drug Administration, the Verification Center of the State Food and Drug Administration, and the Beijing Municipal Food and Drug Administration participated in the supervision
.