Wanbangde Pharmaceutical Group's Solid Dosage Form Workshop No. 2 Successfully Completes GMP Re-certification

From February 25 to 27, a three-member GMP certification expert team dispatched by the Zhejiang Provincial Drug Certification and Inspection Center visited Wanbangde Pharmaceutical Group to conduct a three-day on-site re-certification inspection of the company’s Solid Dosage Form Workshop No. 2. During the inspection, the expert team thoroughly praised the workshop’s production environment, as well as the establishment and implementation of its quality management system, and expressed strong recognition of the company’s robust GMP compliance efforts.

During the inspection, the expert team reviewed Wanbangde Pharmaceutical Group’s production schedule and processes, beginning with an initial meeting. At the meeting, Lin Hong, Deputy General Manager of the company, delivered a welcoming speech, while Jiang Yuehua, Director of QA, presented an overview of the company and reported on the implementation of GMP practices in the second solid dosage workshop. The expert team carefully listened to the presentations, thoroughly examined the GMP management documents and various archival materials, and engaged in focused discussions and inspections centered specifically on the quality management practices within the second solid dosage workshop.

Following this, the expert team conducted an in-depth, on-site dynamic inspection of the Solid Dosage Formulation Workshop No. 2, meticulously examining all aspects closely related to pharmaceutical production—including people, equipment, materials, methods, environment, and testing. The team thoroughly assessed areas such as organizational structure and staffing, production management, facility and premises, equipment, raw materials and products, validation and verification, documentation control, quality control and quality assurance, product distribution and recall procedures, as well as self-inspection practices. The experts approached their review with great diligence, asking detailed questions, while company staff from various departments worked closely together, providing comprehensive and insightful answers to critical issues at every stage. After three intense and rigorous days of on-site evaluation, the expert team fully recognized the robust quality management and assurance systems in place at Solid Dosage Formulation Workshop No. 2. At the same time, following a comprehensive analysis of the workshop’s overall operations, they offered valuable recommendations addressing identified areas for improvement.

It is reported that, in order to successfully complete the once-every-five-year GMP re-certification process, strengthen production quality management, and enhance the company's overall competitiveness, Wanbangde Pharmaceutical Group has been intensely preparing for the GMP re-certification since the end of 2018. The entire organization has worked collaboratively, with the Quality Department and the Solid Dosage Form Workshop taking the lead. Relevant departments have each assumed specific responsibilities, focusing efforts on advancing the preparation work from three key areas. First, tasks and objectives have been meticulously broken down and further refined, ensuring that every item required for the certification inspection is thoroughly addressed. Second, clear roles and responsibilities have been assigned to individuals, with the Quality and Production Departments jointly establishing a dedicated GMP Task Force during the preparation phase. This team has ensured that all responsibilities—whether departmental, positional, or individual—are clearly defined and aligned with strict adherence to the certification timeline, thereby maintaining steady progress. Third, the company has committed fully to executing every step of the process, rallying everyone across departments to work as one cohesive unit. Regular coordination meetings have been held to promptly address any challenges or obstacles encountered along the way. In addition, the company has brought in external GMP consultants to conduct comprehensive GMP audits, fostering a stronger awareness of risk management and driving continuous improvement in the quality management system.

Thanks to the thorough preparation for the GMP re-certification, the Second Solid Dosage Form Workshop of Wanbangde Pharmaceutical Group successfully obtained the *Pharmaceutical GMP Certification* on March 11, following an on-site inspection by a panel of experts and approval from the Certification Review Center. The certification covers tablets, capsules, and granules, with a validity period extending until March 10, 2024. This successful completion of the GMP re-certification underscores the company’s commitment to maintaining high standards in production and quality management. Moving forward, Wanbangde Pharmaceutical Group remains steadfast in its confidence, leveraging quality improvements to drive the company toward transformative growth and continued success—working tirelessly to help the enterprise achieve new heights of excellence!