From February 25th to 27th, a three-person GMP certification expert group appointed by Zhejiang Drug Certification and Inspection Center came to Wanbangde Pharmaceutical Group to conduct a three-day GMP recertification on-site inspection of the second workshop of solid preparations. Through the inspection, the expert group fully affirmed the construction and implementation of the workshop production environment and quality management system, and recognized the company's GMP implementation.

During the inspection, the team of experts conducted inspections and determined the process based on the production arrangements of Wanbangde Pharmaceutical Group, and held the first meeting first. At the meeting, Lin Hong, deputy general manager of the company, delivered a welcome speech, and Jiang Yuehua, director of QA, reported the company's basic profile and the implementation of GMP in the second solid preparation workshop. The expert group listened carefully to the report, reviewed the GMP management documents and various archives in detail, and exchanged and inspected the production quality management of the second workshop of solid preparations.

Subsequently, the expert group went deep into the second workshop of solid preparations to conduct on-site dynamic inspections, focusing on the aspects of people, machines, materials, methods, environment, and testing that affect drug production, and conducted inspections on institutions and personnel, production management, workshops and facilities, equipment, etc. Material and product, confirmation and verification, document management, quality control and quality assurance, product sales and recall, self-inspection and other aspects are carefully and comprehensively inspected. The expert group checked carefully and asked carefully, and the staff of various departments of the company cooperated closely and answered the key questions in each link in detail. After three days of intense and strict on-site inspection, the expert group fully affirmed the quality management and quality assurance work of the second workshop of solid preparations. Opinion.

It is reported that in order to do a good job of GMP re-certification every five years, strengthen the production quality management level, and improve the comprehensive competitiveness of enterprises, Wanbangde Pharmaceutical Group has entered the intensive preparation for GMP re-certification since the end of 2018. The quality department and the solid preparation workshop take the lead, and the relevant parties are responsible for their respective responsibilities, and promote the certification preparation work from three aspects. The first is to refine and decompose the target tasks, and re-decompose and refine the items applying for certification inspection. The second is to clarify the division of labor and assign responsibilities to people. During the preparation period for certification, the quality and production departments jointly set up a GMP working group, assigning various work responsibilities to departments, posts, and people, and arrange work in strict accordance with the certification time node to ensure work. schedule. The third is to go all out to implement it. All departments of the company are united and motivated to implement each item one by one. Coordination meetings have been held for many times to solve the difficulties and problems in the work. In addition, the company also employs external GMP consultants to conduct GMP audits, introduce risk management awareness, and promote continuous improvement of the quality management system.

Due to the sufficient preparations for GMP re-certification, finally, after being reviewed and approved by the expert group on-site inspection and the certification inspection center, on March 11, the second solid preparation workshop of Wanbangde Pharmaceutical Group successfully obtained the "Drug GMP Certification" certificate, and the certification scope is tablet, Capsules, granules, valid until March 10, 2024. The successful conclusion of the GMP re-certification work is an affirmation of the company's production quality management level. In the future, Wanbangde Pharmaceutical Group will strengthen its confidence, promote the company's breakthrough development with quality improvement, and strive to create greater glories for the company!