Recently, Dahua Company, led by the Quality Department, established a GMP self inspection team to organize and carry out GMP self inspection activities for drug production and operation. The entire self inspection activity was carried out continuously for 4 days, involving departments such as sales, personnel, production, engineering, warehousing, testing, and quality assurance.

According to the quality system requirements of Dahua Company, GMP self inspection of the enterprise shall be conducted at least once a year. This self inspection is a routine audit during the operation of the quality system, and the basis for self inspection is the "WHO Inspection Guidelines".

Before the self inspection activity officially begins, the self inspection team evaluates the corrective measures formulated for the defects discovered during last year's self inspection to ensure their effectiveness and implementation. During the self inspection activity, team members carefully checked every aspect of the process, including raw material supplier management, material acceptance, production operations, quality control, finished product release, and product transportation management. And evaluate each specific detail to further explore potential risks and hazards. Taking the production process of drug core base materials as an example, in addition to strict monitoring of daily process parameters and accurate and effective testing results, the self inspection team requires control of the film bags containing drug core base materials. The film bags need to have clear supply channels, establish quality standards and testing methods, and comprehensively reduce quality risks.

It is reported that a total of 11 risk defects were found during self inspection, all of which are general defects. At present, various departments of Dahua Company have formulated rectification plans for relevant defects. After the rectification is completed, daily production and operation will be carried out with a more complete quality system.