China OECD GLP-Certified Laboratory

In December 2024, China's JJR Laboratory successfully obtained Good Laboratory Practice (GLP) certification from the Organisation for Economic Co-operation and Development (OECD) after a rigorous review and evaluation. It became one of the first biocompatibility testing centers for medical devices in China to achieve this qualification.

During the on-site audit, the expert panel highly recognized the laboratory’s capabilities in personnel management, project management, facility management, and archive management. The team unanimously agreed that the JJR Laboratory met the GLP requirements and approved its OECD GLP certification.

The OECD GLP principles, developed based on scientific practice by member countries such as the United States, France, and Germany, apply to non-clinical safety studies of pharmaceuticals, pesticides, cosmetics, veterinary drugs, and medical devices. As a mature quality control system, GLP regulations help ensure the high quality and reliability of test data, thus forming a basis for mutual acceptance of data among nations.

This successful OECD GLP certification marks another milestone in the development of JJR Laboratory following its successful IAS audit in March 2024. It signifies that the laboratory has reached an internationally advanced level in laboratory management and testing services, further demonstrating its professional capabilities in service quality and standards.

JJR Medical Laboratory in China covers a total area of over 15,000 square meters, including a 3,000-square-meter animal facility and more than 1,000 sets of advanced equipment, including a 10-meter electromagnetic anechoic chamber. The lab houses 13 major testing divisions, including electromagnetic compatibility, electrical safety, biosafety, specific product performance, microbiology, physico-chemical analysis, software testing, and cleaning and disinfection validation. Its testing capabilities are recognized and supported by national and local drug regulatory authorities.

The laboratory operates strictly in accordance with ISO/IEC 17025 standards and has received national CMA qualification, as well as CNAS and IAS accreditations. It is a recognized laboratory under CBTL, A2LA, and OECD GLP, and is authorized by FCC, IC, and VCCI. It has also been approved for both large and small animal testing, currently capable of conducting studies involving monkeys, pigs, dogs, sheep, rabbits, and rodents. Its test reports carry international credibility.