Qidu Metrology and Testing Center Passes CNAS Calibration Laboratory On-Site Assessment

Recently, experts from the China National Accreditation Service for Conformity Assessment (CNAS) visited Qidu Pharma to conduct an on-site audit, documentation review, practical operation assessment, and system evaluation of the Company's Metrology and Testing Center. The center successfully passed the national-level assessment.

As the highest authoritative body for laboratory accreditation in China, CNAS accreditation brings significant benefits to Qidu Pharma. First, it helps break down quality certification barriers in overseas markets. CNAS calibration reports and data are mutually recognized by more than 80 countries and regions, supporting pharmaceutical exports and international business cooperation. Second, it enables international high-standard, full-chain quality management, reducing measurement errors at the source, lowering hidden drug quality risks, and ensuring that data at every stage is authentic and controllable. Third, it demonstrates a refined quality management capabilities, enhances Qidu's industry reputation and competitive advantage, and helps the company undertake high-end R&D projects and expand cooperation resources.

During the inspection, the CNAS expert group strictly followed CNAS-CL01:2018 Accreditation Criteria for the competence of Testing and Calibration Laboratories and relevant industry standards. The experts visited functional areas of the center's laboratories and conducted on-site inspections of laboratory environmental conditions, equipment configuration, safety control measures, and standardized zoning. They reviewed item by item the center's quality management system documents, original calibration records, equipment traceability certificates, personnel qualification files, environmental monitoring data, and other materials, verifying the standardized, complete, and compliant operation of the system. Personnel were randomly selected for on-site practical assessments of metrological calibration items, evaluating operational compliance, data processing accuracy, emergency response capabilities, and control of measurement traceability. All staff of the center actively cooperated, fully demonstrating standard operating procedures, a sound management system, and solid professional competence, which was fully recognized by the expert group.

Metrology and testing run through the entire process of pharmaceutical R&D, production, and inspection. Accurate metrological data is the foundation for drug quality and safety, stable production, and controllable efficacy. Qidu's Metrology and Testing Center was officially established in 2005. Before its establishment, all instrument and meter calibration relied entirely on external third parties. Over the past two decades, the center has continuously expanded its measurement standards, upgraded hardware equipment and software, improved its management system, and enhanced its independent calibration capabilities. It has solved problems such as long external calibration cycles and delayed data traceability, and can meet the company's needs. To date, it has established 18 corporate measurement standards covering thermal, mechanical, chemical, and other fields, calibrates more than 20,000 instruments and meters annually, achieves a self-calibration rate of 98%, and saves over RMB 2 million in calibration costs each year.

To further improve the standardization of metrology work and better meet Qidu's full-value-chain development and internationalization needs, the Center launched the CNAS accreditation project in September 2025. It successively completed the renovation and optimization of laboratory function rooms, standardized the division of functional areas, fully equipped professional instruments and equipment, expanded the professional team, compiled one quality manual, 33 procedure documents, and 29 standard operating procedures, and developed more than 60 types of metrology record forms. These efforts established a complete institutional chain covering all stages, including daily management, on-site operations, and data retention, laying a solid foundation for the standardized implementation of calibration work and the successful passing of this assessment.

Taking this successful assessment as a new opportunity, the Metrology and Testing Center will expand the scope of metrology calibration services, overcome difficulties in high-precision metrology and testing, upgrade metrology and testing technologies, improve the standardized metrology service system, and regularly carry out quality control activities such as measurement audits, interlaboratory comparisons, and intermediate checks. It will continuously improve calibration accuracy and service efficiency, give full play to metrology's core role as the “cornerstone of quality and pioneer of technology” to support the company's high-quality development with precise measurement. At the same time, it will actively develop metrology testing and calibration services for pharmaceutical and chemical enterprises, achieving a transformation and upgrade from a sole “internal supporting function” to an integrated “market-oriented external services.”