Enhancing Quality, Strengthening Enterprises | Wanbande Pharmaceutical Group Successfully Launches Internal Quality Inspection Activities

Date:

05 Jan,2024


To evaluate the operational status of the company’s quality management system, further enhance employees’ awareness of quality risk prevention, and ensure the company consistently and effectively implements GMP standards, Wanbangde Pharmaceutical Group conducted a two-day annual self-inspection of its pharmaceutical production quality management practices from December 15 to December 16, 2023.

 

First Self-Inspection Meeting

On the morning of December 15, the first meeting for the 2023 GMP self-inspection initiative was successfully held in the conference room on the 10th floor of the R&D Building. Lin Hong, Deputy General Manager of the company, along with relevant personnel from all departments and workshops, attended the meeting.

To ensure the smooth execution of the self-inspection process, the company has established an annual self-inspection team. The team is led by Deputy General Manager Lin Hong, Deputy General Manager Qu Junbiao, QA Department Director Jiang Yuehua, QC Division I Deputy Director Lin Jinxin, and QA Department Manager Wang Zhuhua. Its members include representatives from various departments and workshops, as well as select QA personnel.

During the meeting, the annual self-inspection plan was read aloud, and an overview was provided on the closed-loop status of changes, deviations, OOS/OOT/OOE results, and abnormal events that occurred from January to November 2023. Additionally, the status of unresolved corrective actions from self-inspections, official audits, and contracted production audits was discussed. A checklist was finalized, and key focus areas for this round of self-inspection were emphasized to all members of the self-inspection team.

 

 

At the meeting, Deputy General Manager Lin Hong delivered a speech, during which she stated:

1. Self-inspection is a process of refining our quality management system—requiring us to identify issues, pinpoint problems, and collaboratively resolve them through collective wisdom. For this inspection, we encourage the inspection team members to approach it seriously, avoiding mere formalities and ensuring that no step is overlooked. Meanwhile, reception staff must face the issues head-on, adopting a self-critical mindset by openly addressing existing problems—absolutely no covering up or sidestepping allowed.

2. By conducting Quality Month initiatives and ongoing quality management activities, we must ensure that the principle of "everyone values quality, everyone contributes to quality, and everyone benefits from quality" becomes a matter of both words and actions. Only by fostering a consistently positive environment can we sustain the PDCA cycle, enabling continuous improvement and growth in our quality management efforts.

 

Self-inspection work is being carried out rigorously.

From December 15 to December 16, led by the team leader, each inspection group conducted a comprehensive review of all company departments—particularly focusing on this year’s newly established C Area of the Injectable Dosage Form Workshop No. 2 and Workshop 801—covering areas such as quality management, facility and equipment oversight, materials and products, validation and verification, document control, production management, quality control, quality assurance, and adverse event reporting. The teams were determined to avoid superficial inspections, ensuring instead a thorough, end-to-end evaluation that extends "horizontally across the board and vertically to the very bottom."

 

Self-inspection final meeting

On December 19, the final meeting of the self-inspection initiative was held successfully. The meeting fully recognized the achievements made during this round of self-checking, and QA presented a detailed report on the defects identified during the process. Based on these findings, department heads at each unit explained the root causes of the issues on-site. Attendees then engaged in discussions about corrective and preventive measures, outlining specific action items for improvement. Additionally, each workshop took the opportunity to reflect on its own practices, drawing lessons from the identified defects to ensure continuous refinement—addressing any existing problems while striving even harder in areas where performance is already strong.

 

 

Quality improvement has no end—only a continuous journey. Wanbangde Pharmaceutical Group conducts regular, self-assessed quality inspections every year, ensuring rigorous and comprehensive quality management. Through these inspections, we identify excellence and verify tangible results, staying true to the company’s original vision and mission while wholeheartedly driving our commitment to achieving a "qualitative" leap in our overall quality management practices.

 

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