[Source: Shanxi Provincial Drug Administration_Drug Supervision News] In order to strengthen vaccine supervision, continuously integrate quality management concepts into supervision work, and better promote the standardized and effective operation of the vaccine supervision quali

[Source: Shanxi Provincial Drug Administration_Drug Supervision News]

In order to strengthen vaccine supervision, continuously integrate quality management concepts into supervision work, and better promote the standardized and effective operation of the vaccine supervision quality system, the Provincial Drug Administration recently organized the internal audit of the vaccine supervision quality system in 2022.

According to the work arrangements at the beginning of the year, the Provincial Drug Administration organized an internal review of the vaccine supervision quality system in an orderly manner. First, set up a special working group. In view of the systematic characteristics of the quality system, an internal audit working group with the leadership of the bureau as the group leader was established. The working group has seven audit teams, which clarified the goals, implemented responsibilities, and refined the division of labor. The second is to achieve full coverage of audits. According to the five contents of basic systems, human resources, inspection, training and performance, a comprehensive "physical examination" was conducted on the provincial bureau's vaccine supervision organizational system and supervision business links, achieving full coverage of the organizational system and supervision business. The third is to adhere to problem-oriented approach. In accordance with the content of the quality management manual, the internal audit working group reviewed the information on site, inspected the supervision business on-site, and checked it one by one item, and conducted a comprehensive investigation and identification of possible risk points in the quality management system from the system and operational level. Fourth, implement rectification measures. During the audit process, the working group fully communicated, discussed in depth and analyzed with personnel from various business units and business departments. In response to the problems and shortcomings found in the internal audit, they carefully found the causes, proposed practical and feasible solutions, and actively implemented rectification.

passed the internal review of the annual vaccine supervision quality system, and the operation of the vaccine supervision quality system of the Provincial Drug Administration has become more standardized, and the foundation for ensuring the safety and effectiveness of vaccination in the province is more solid. (Liu Suping)

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