The Code of Quality Management for Non-clinical Research of Drugs, or GLP for short, is the basic principle that must be followed for pre-clinical research of drugs. It is also a fundamental measure to improve the quality of new drug research from the source and ensure the safety of drug use by the people. After years of development, the distance between China’s GLP and developed countries such as the United States has gradually narrowed. Medicilon ranks relatively high in the ranking of Chinese GLP institutions. It is a CRO company that provides a complete set of pre-clinical approval applications and meets the Chinese GLP and American GLP standards.
Because my country’s GLP work started late, it was not until the end of the 1980s that the concept of GLP was introduced into China. Since December 1993, my country has only begun to draft and pilot the implementation of GLP specifications. With the development of the economy and the strengthening of people’s awareness of health, the domestic understanding of GLP has been greatly improved. In the establishment and improvement of the GLP system, there is also Some gratifying progress has been made, and the international mutual recognition of GLP specifications has gradually attracted people’s attention. However, problems such as the uneven overall development of my country’s GLP institutions and the need to improve the external environment of GLP are still outstanding. GLP institutions can only ensure the long-term and stability of their services through continuous external mandatory inspections and strengthening of internal quality assurance systems, thereby providing drug evaluation services that meet international standards. The gap between China and foreign countries in GLP system construction and practice is mainly in the following three aspects.
GLP is an intermediate link in the research and development of new drugs, and is bound to be affected by the entire environment and system. The overall environment of GLP in the United States and Europe is very good. There is a complete system from medicine to clinical, including laboratory animals, facility supply, feed bedding, equipment maintenance and other links are relatively mature. China’s external environment needs to be gradually improved and developed. The gap in the external environment has also become a major factor affecting the internationalization of China’s GLP institutions. Moreover, the OECD-GLP specifications cover food, dyes, animal food additives, human and veterinary drugs, human medical devices, biological products and electronic products, while my country’s GLP only includes human drugs.
In the construction of GLP laboratories in my country, government departments at all levels have given great support. In recent years, great progress has been made. However, the gap with foreign countries is still obvious in some aspects, such as the purity and concentration analysis of test substances. Aspects, QAU inspection aspects and safety pharmacology aspects. In the past, the domestic new drug registration application materials did not explicitly require the concentration analysis of the test substance in the preclinical drug safety evaluation experiment, so it has not received due attention, and the construction in this area is also obviously weak. In terms of QAU inspections, the QA staff of the GLP center are mostly in a situation of studying and working due to their inexperience.
my country’s GLP started late compared with developed countries, and there is a certain gap, but our most critical problem is not that there is no regulation, but that the regulation is not well implemented. In terms of hardware, the gap between us and foreign countries is not the biggest, and it can be quickly made up and improved. However, if the gaps in the implementation, management, and personnel of the regulations can be overcome, the quality of my country’s GLP will be greatly improved at present. Most of the safety evaluation experiments conducted in GLP-certified laboratories in my country are basically copying the OECD GLP procedures, such as the requirements for the organization and personnel of GLP laboratories, and the requirements for experimental facilities, equipment and experimental materials. Requirements and regulations on inspection points and operating specifications of facilities and equipment, etc., but the overall procedures, management, and technical level are still far from the OECD-GLP.
GLP management needs to be continuously improved and strengthened. It is a continuous process. This requires everyone from the head of the organization to the laboratory to continuously strengthen the awareness of quality management. Therefore, it is not easy for a GLP organization to always maintain a certain level. Therefore, maintaining this level requires on the one hand mandatory inspections by the country or inspections by the client, on the other hand, it needs to continuously improve SOP (standard operating procedures), strengthen the quality assurance system’s control of the experimental process, and establish a system and system guarantee.
Medicilon successfully passed the US FDA GLP on-site inspection
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