Report on Self-inspection Results of Shandong Ruisheng Pharmaceutical Excipients Co., Ltd.: Practice and Optimization of Quality Standards

According to the "Good Manufacturing Practice", "Good Manufacturing Practice for Pharmaceutical Excipients" and the requirements of the company's internal GMP documents, and according to the immediate self-inspection plan, the company carried out the self-inspection work on June 11. The self-inspection team was headed by General Manager Li Chengfang and Deputy Head by Quality Minister Li Hong. The team members covered the main members of each department.

From 9:00 to 12:00 on the same day, team members conducted on-site inspections on the factory area, laboratory, production workshop, finished product warehouse and raw material warehouse, and conducted software inspections such as documents and related records from 14:00 to 16:30. At the end of the self-inspection meeting, the team members reported the inspection situation one by one, and Mr. Li made a final overview: after a comprehensive inspection, the overall operation of each link met the specification requirements, the system was effective, the production site was orderly, and the records were complete and accurate. However, deficiencies were also found: there were omissions in details and occasional sundries in the hygiene of the production site; The individual placement of laboratory articles and instruments is not regular enough, which affects the convenience and efficiency of operation. Some employees' records are written in irregular fonts, which is easy to cause identification troubles. Follow-up companies will continue to strengthen management, consolidate the results of self-inspection, to ensure the quality of pharmaceutical accessories production.

quality is the fundamental survival of enterprises, norms are the cornerstone of production operation. These seemingly subtle deficiencies are actually related to product quality and safety and the level of company management. Li Zong stressed: All relevant departments must attach great importance to it and act quickly: the production workshop needs to establish a health inspection mechanism, and the personnel should be assigned to clean it regularly to eliminate the dead corners of health. The laboratory should optimize the placement standards of articles and instruments, clarify the partitions and improve the operation efficiency. For posts involving records, strengthen the training of staff writing standards to ensure that the records are clear, accurate and traceable.

self-inspection is of great significance. On the one hand, through a comprehensive review of the entire production process, timely discovery and rectification of subtle problems can effectively prevent quality risks, ensure the quality and safety of pharmaceutical excipients, and conform to industry standards and corporate quality standards; on the other hand, self-inspection Promote the collaborative optimization of various departments, strengthen the awareness of employee norms, promote the continuous improvement of production management, help the company improve the overall operation level, and build a solid foundation for product quality, maintain the market reputation and competitiveness of enterprises. Subsequently, the company will quickly rectify the problem, improve the details, and continue to improve the quality of management.

The

self-inspection team confirmed that the report was true.

Team Leader: Li Chengfang

Date: June 15, 2025