The pharmaceutical production quality assurance system-Pharmaceutical Non-clinical Research Quality Management Practices (GLP) is the key to improving the quality of pharmaceuticals. It is a common practice for non-clinical drug safety evaluation work in the world, and it is also the international toxicology data exchange and mutual recognition of information. The basics. The GLP laboratories owned by the top institutions in the ranking of Chinese GLP institutions can strictly control all aspects of drug non-clinical safety evaluation trials, and can eliminate subjective and objective factors that may affect experimental results to the greatest extent, reduce errors, and ensure experiments The results are true and reliable.
The statutory national drug standards are the only basis for ensuring the quality of drugs and dividing qualified and unqualified drugs. Only if the drug meets the legal quality standards, can the curative effect be allowed to be sold, otherwise it cannot be sold. In addition, the importance of drug quality also reflects the implementation of GLP, GCP, GMP, GSP, GAP and other quality management systems in the country to standardize drug development, production, distribution, and use behavior, and implement strict quality supervision and management to ensure drug quality.
Institutions with the highest ranking in China’s GLP institutions can conduct safety evaluation tests on drugs under the guidance of CLP regulations. By giving test drugs to experimental animals, observe the symptoms and severity of toxic reactions in experimental animals. Foreseeably provide the target organs of toxic and side effects, the degree of damage and the dose of non-toxic reactions for clinical medication, reduce the risk of clinical research, and improve the success of clinical research.
GLP regulations, as the norms that must be followed for pre-clinical drug research, are the guidelines that the international drug safety evaluation laboratories abide by, and they are also the basis for the international mutual recognition of drug research data. That is to say, only if the drug safety evaluation laboratory passes the GLP certification, the data and information provided by it can be internationally recognized. The purpose of formulating and implementing GLP is to let the industry understand the expectations and requirements of regulatory agencies, provide an industry standard-implementation standard, improve the overall quality of research, and facilitate the exchange of test methods and technology at home and abroad. After years of development, the distance between China’s GLP and developed countries such as the United States has gradually narrowed. Medicilon is 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 U.S. GLP standards.
The regulations and concepts of GLP are the main means to standardize experimental operations, so as to ensure the authenticity and reliability of research results, ensure the quality of drug preclinical safety evaluation, and ensure the safety of listed drugs. GLP regulations strictly control all aspects of drug safety evaluation tests. In terms of the software and hardware of the drug safety evaluation agency, the GLP regulations clearly stipulate the setup of the organization and the responsibilities of the personnel. It also clarified the necessary SOPs and the equipment and facilities that must be equipped to meet the safety evaluation institute. In terms of the implementation of safety evaluation research, GLP regulations regulate the formulation of experimental protocols, experimental operations, data recording, animal breeding, and the writing of summary reports. This can minimize the occurrence of various errors. Through timely and accurate records, the traceability of the non-clinical research process is ensured to the greatest extent, thereby improving the quality and credibility of drug non-clinical safety evaluation research.
Medicilon successfully passed the US FDA GLP on-site inspection
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