Guorei Yinuo successfully passed the OECD GLP certification.
Release time:
2025-08-28 19:04
Keywords:
GLP,Medication
From July 15 to July 17, 2025, GLP inspectors from the Organisation for Economic Co-operation and Development (OECD) conducted a three-day on-site GLP inspection of Xixian New Area Guorui Yinuo Drug Safety Evaluation and Research Co., Ltd. (hereinafter referred to as "Guorui Yinuo"). Guorui Yinuo has... Zero defects Successfully passed the on-site inspection.
Guorei Yinuo obtained the GLP certification from the Organization for Economic Co-operation and Development (OECD) on August 13, 2025. The scope of this OECD GLP certification includes:
1. Toxicity Studies: Single-dose toxicity studies, repeated-dose toxicity studies, safety pharmacology studies, local toxicity studies, immunogenicity studies, reproductive toxicity studies, carcinogenicity studies, and toxicokinetic studies;
Toxicity testing: Single-dose toxicity study, repeated-dose toxicity study, safety pharmacology study, local toxicity study, immunogenicity study, reproductive toxicity study, carcinogenicity study, toxicokinetic study;
2. Mutagenicity Studies: Ames test, micronucleus assay, chromosomal aberration assays, mouse lymphoma assay, etc.;
Mutagenicity testing: Bacterial reverse mutation assay, micronucleus assay, chromosomal aberration assay, in vitro mammalian cell gene mutation assay, etc.;
3. Analytical Chemistry and Clinical Chemistry Testing: Analysis of biological samples, pesticide residue analysis, veterinary clinical pathology (clinical laboratory testing), method validation, and analyte analysis;
Analytical and clinical chemistry testing: Analysis of residues in agricultural samples and biological samples, veterinary clinical pathology, methodology validation, and test article analysis;
4. Veterinary Histopathology: Pathological evaluation of non-clinical safety and efficacy, pathological studies and diagnosis of animal diseases, etc.
Veterinary histopathology: Non-clinical pathological evaluation of safety and efficacy, pathological research and diagnosis of animal diseases, etc.
The scope of this OECD GLP certification includes: chemicals, pesticides, and veterinary drugs.
Scope of registration: Industrial chemicals, pesticides, veterinary medical products.
The OECD expert panel conducted a comprehensive and meticulous inspection of our company’s organizational management, personnel, experimental facilities, instruments and equipment, computerized systems, experimental materials, standard operating procedures, quality assurance system, trial operations, and documentation archives. They also selected several tests that comply with OECD GLP guidelines for a thorough traceability review. All inspection results met the GLP requirements.
During this GLP certification inspection, the OECD expert panel fully affirmed our company’s GLP system. The panel particularly extended warm congratulations on our company’s inspection results. Our facilities’ hardware and software capabilities, quality management system, staff technical competence, and GLP awareness all received thorough recognition.
Guorei Yinuo has successfully obtained OECD GLP certification, meaning that the institution’s test data will be recognized globally—including in numerous OECD member countries such as the United States, Europe, Japan, Australia, and Canada—as well as in countries adhering to MAD standards, thus achieving “international mutual recognition.” This opens up a broader stage for Guorei Yinuo in the global pharmaceutical industry. It also signifies that the institution is fully capable of conducting non-clinical evaluation studies and testing for human pharmaceuticals, veterinary pharmaceuticals, pesticides, chemicals, and other products in accordance with the requirements of China’s NMPA GLP, the China National Accreditation Service for Conformity Assessment (CNAS) GLP, and the Organisation for Economic Co-operation and Development (OECD) GLP. As a result, the institution’s quality system has reached a new milestone and fully meets internationally recognized standards, enabling it to satisfy registration requirements in various countries and regions and helping its products gain rapid access to international markets.
Guorei Yinuo is committed to promoting the development of GLP in Shaanxi Province and throughout China. We operate and manage our laboratories in compliance with the requirements of China’s NMPA GLP, the China National Accreditation Service for Conformity Assessment (CNAS) GLP, and the Organisation for Economic Co-operation and Development (OECD) GLP, providing groundbreaking research services for human pharmaceuticals, veterinary drugs, pesticides, chemicals, and other products. Guorei Yinuo will continue to share advanced concepts and practical experiences in GLP management across multiple fields, delivering more efficient and high-quality services for registration applications in China and globally. At the same time, we will keep enhancing our cutting-edge technological systems, continuously developing and building a world-class, high-end platform, and cultivating more professionals with an international perspective. This will lay a solid foundation for achieving higher levels of development and ultimately benefiting human health.
Introduction to OECD GLP
The Organization for Economic Co-operation and Development (OECD), often referred to as the OECD, was established in 1961 and is headquartered in Paris. It is an intergovernmental international economic organization composed of member countries including the United States, France, the United Kingdom, Germany, and others.
Based on scientific and practical experience from various countries, the OECD Good Laboratory Practice (GLP) Principles have been established. These principles apply to non-clinical safety studies involving substances found in pharmaceuticals, pesticides, cosmetics, veterinary drugs, as well as food additives, feed additives, and industrial chemicals. As a well-established quality-control mechanism, the GLP regulations help ensure the high quality and reliability of test data, thereby forming the basis for mutual recognition of data among countries. By avoiding redundant testing, these regulations prevent unnecessary waste for governments and enterprises worldwide, while also contributing to the protection of human health and the environment.
Related News
Contact phone number
Ms. Li:+86 15760970681
Mr. Su:+86 19991001701
Landline:+86-29-33656828
Company Address
4th Floor, Unit C. Building 9. Small and Medium-sized
Enterprise Park, Airport Industrial Zone Airport New Ciy,Xixian New Area, Shaanxi Province
©2026 Xixian New Area Guorui Yinuo Drug Safety Evaluation and Research Co., Ltd.
WhatsApp：8613940397353
Email：hr-xian@grglp.com
Landline：862933656828
Mr. Su：8619991001701
Ms. Li：8615760970681