Guangdong Kerun Biopharmaceutical Co., Ltd. has successfully passed the Ministry of Agriculture’s GMP certification inspection.

On May 25–26, 2017, the Ministry of Agriculture’s GMP inspection and acceptance expert panel conducted an on-site review of Guangdong Kerun Biopharmaceutical Co., Ltd. Guangdong Kerun successfully passed the Ministry’s GMP inspection with outstanding results. This assessment marked both a re‑inspection, following the one in 2012, and the first GMP evaluation since the company’s new facility was completed.

On the afternoon of May 25, a four-member GMP inspection team from the Ministry of Agriculture visited our company and convened its inaugural meeting in the second-floor conference room. First, Team Leader Chen Zhihong read out the rules of conduct for this inspection and confirmed the scope of the assessment. She then carefully listened to a brief overview of the company’s development presented by the General Manager and a detailed report on GMP implementation delivered by the Quality Department Manager. Following this, the expert panel conducted an in-depth, meticulous, and comprehensive review of the company’s GMP management practices, production processes, and quality‑control systems, visiting the laboratory, various production workshops, and the warehouse.

    5 month 26 On the morning of [date], the expert panel conducted a thorough review of the company’s document management records and related documentation pertaining to production, quality, materials, equipment, documentation, validation, self‑inspections, and personnel. Throughout the review, they raised questions at various points, which were promptly addressed on site by the relevant company personnel. Subsequently, the panel held discussions with key personnel from the company’s production, quality, and materials departments to gain a deeper understanding of the company’s… GMP Regarding the operational status, employees in relevant positions at the company provided further elaboration on the issues raised by the expert panel.

Following a one-day assessment and acceptance review, the expert panel unanimously concluded that Guangdong Kerun Biopharmaceutical Co., Ltd. is able to organize production in strict compliance with GMP standards. The company boasts a well‑structured workforce and organizational framework, with clearly defined roles and responsibilities; its personnel composition, qualifications, and training programs are fully aligned with production needs. Its production equipment and testing facilities adequately meet both manufacturing and quality‑control requirements, and its production and quality‑management systems are fully compliant with regulatory standards. The four experts on the panel offered high praise for all aspects of the company’s operations. Particular emphasis was placed on the company’s automated production line in the GMP‑compliant workshop, which has significantly boosted capacity, enhanced product‑quality control, and markedly reduced direct contact between frontline workers and pharmaceuticals, thereby greatly improving the working environment and strengthening workplace safety. The company’s automated production line serves as a valuable model for technological upgrading and innovation within the industry. The expert panel also identified certain areas for improvement, provided constructive recommendations for corrective action, and expressed the hope that Guangdong Kerun will continue to uphold rigorous standards and exacting quality requirements, producing high‑quality veterinary medicinal products and making an even greater contribution to China’s animal husbandry sector.

The company’s general manager delivered a speech of gratitude, stating that, moving forward, the company will continue to rigorously comply with veterinary‑drug GMP standards, uphold a commitment to excellence, strengthen training and capacity‑building, maintain high‑standard, long‑term management systems, and earnestly fulfill its social responsibilities as a veterinary‑drug manufacturer, thereby repaying society with high‑quality products.

Chen Zhihong, head of the expert panel, read out the on-site inspection report and the comprehensive evaluation results for GMP certification. Guangdong Kerun Biopharmaceutical Co., Ltd. successfully passed the Ministry of Agriculture’s GMP acceptance inspection, and a signing ceremony marking the successful completion of the inspection was held on the spot.

This successful re‑inspection is a testament to the company’s five years of GMP compliance and effective GMP management, as well as to the GMP‑compliant automated production lines at our new facility. Guangdong Kerun will take this as a fresh starting point, continuing to uphold stringent standards and rigorous requirements, meticulously controlling every stage of the process, delivering high‑quality products, and strengthening the Kerun brand.