The verification of the GLP/GCLP laboratory is a systematic project, which requires experience and professional knowledge. Sciway provides consulting services for newly built GLP/GCLP laboratories, non-GLP/GCLP laboratories that need to be transformed into GLP/GCLP laboratories, or GLP/GCLP laboratories that need to be re-evaluated with complete services to meet GLP/GCLP requirements.
Introduction to GLP/GCLP
GLP, Good Laboratory Practice, corresponds to the national implementation of the "Non-clinical Drug Research Quality Management Practices". This standard is the basic guideline that drugs must follow for preclinical research. Good Clinical Practice, abbreviated as GCP, is the management standard of drug clinical trials, which aims to ensure the standardization of clinical trial process, the scientific and reliable results, the rights and the safety of subjects. As GCP put emphasis on the clinical trial part and has less relevant content on clinical sample analysis experiments, the industry mainly quotes GLP to regulate clinical sample analysis laboratories. GCLP came into being in this context.
GLP/GCLP embodies a series of principles, stipulating that the planning, execution, monitoring, recording and filing of laboratory research must be within the corresponding framework, strictly control various subjective and objective factors that may affect the accuracy of experimental results, and reduce the occurrence of errors to ensure the authenticity of experimental results. GLP/GCLP helps to ensure to regulatory authorities (such as CFDA, FDA, etc.) that the submitted data can truly reflect the results obtained in the research and can be relied on for risk and safety assessment. The establishment of GLP/GCLP laboratories is of great significance to the evaluation of pharmaceuticals (preclinical research only), pesticides, cosmetics, food additives, feed additives and pollutants, novel foods, pesticides, detergents and other industries. The hazards and risks of consumers (users) and third parties (such as the environment, etc.) also have very important guiding significance.
Sciway Service Introduction
In view of the fact that the verification of GLP/GCLP laboratory is a huge systematic project, it requires very rich experience and professional knowledge background. For many years, Sciway has been committed to perfecting the construction of GLP/GCLP system for clients with a complete construction process (preparation→implementation→improvement) and a group of engineers with laboratory background, including experience from SCIEX, Waters and WuXi AppTec. They have been focusing on GLP/GCLP laboratory verification for many years with deep understanding of the corresponding laws and regulations for verification. Now the company's business has expanded to more than ten first- and second-tier cities such as Shanghai, Beijing, Nanjing, Suzhou, Wuhan, and Chengdu, Sciway is willing to work with colleagues in the industry to improve the GLP/GCLP laboratory.
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