From November 1 to 2, the expert team from the China National Accreditation Service for Conformity Assessment (CNAS) conducted a two-day on-site assessment of the Quality Control Center of Zhuhai United Laboratories. The Center’s applications for 29 expanded testing capabilities under the United States Pharmacopeia (USP), 29 under the British Pharmacopeia (BP), as well as 27 Chinese Pharmacopeia (ChP) standard modification projects were all successfully approved.

The assessment team was composed of three senior experts, including a representative from the United States Pharmacopeia office in China. During the opening meeting, the experts heard a report from Mr. Zhu, Director of the Quality Control Center, on the Center’s quality system operations and continuous improvement achievements over the past three years.

During the assessment, the expert team conducted a comprehensive evaluation of the laboratory’s management system and technical capabilities through blind sample testing, on-site experiments, document review, proficiency testing, and authorized signatory assessments. They also conducted in-depth on-site inspections, carefully reviewing personnel operations, raw data records, instrumentation, and standard material management, and provided valuable suggestions on management review, standard updates and report management.

Following the assessment, all 85 newly added and modified testing items across domestic and international pharmacopeias in the areas of active pharmaceutical ingredients and finished formulations were confirmed to fully comply with CNAS requirements. To date, the Quality Control Center has achieved 121 accredited testing items in the relevant fields, with continuous improvements in both technical coverage and analytical precision.

At the closing meeting, the expert panel spoke highly of the Quality Control Center’s quality management system, technical competence, documentation standards, and professional expertise of personnel, concluding that it fully meets CNAS accreditation requirements.

The successful expansion of testing capabilities under the USP and BP international standards represents an authoritative endorsement of the technical strength of the Quality Control Center of Zhuhai United Laboratories. It marks a significant leap forward in the Center’s testing capabilities. The bilingual (Chinese and English) test reports it issues will now gain broader international recognition, providing strong support for overseas product registration and market access, while enhancing the Company’s brand credibility and global competitiveness.

Looking ahead, the Quality Control Center will continue to uphold its quality policy of “scientific, impartial, accurate, and efficient,” steadily advancing its technical expertise and delivering solid technical assurance for the Company’s internationalization strategy and high-quality development.

About CNAS

The China National Accreditation Service for Conformity Assessment (CNAS) is a national authoritative accreditation body legally designated by the State Administration for Market Regulation. It is responsible for the accreditation of conformity assessment bodies, including inspection institutions and laboratories.

CNAS is a full member of the International Accreditation Forum (IAF), the International Laboratory Accreditation Cooperation (ILAC), the Asia Pacific Laboratory Accreditation Cooperation (APLAC), and the Pacific Accreditation Cooperation (PAC). Accreditations granted by CNAS enjoy broad international recognition and credibility, serving as an important benchmark for evaluating a laboratory’s technical competence and management standards.