药分英文部分1药分文部分1.doc

绪论 GLP (Good Laboratory Practice) 药品非临床研究质量管理规范 Good Laboratory Practice (GLP) deals with the organization, process and conditions under which laboratory studies are planned, performed, monitored, recorded and reported. GLP practices are intended to promote the quality and validity of test data.Published GLP regulations and guidelines have a significant impact on the daily operation of an analytical laboratory. GLP is a regulation. It is not only good analytical practice. Good analytical practice is important, but it is not enough. For example, the laboratory must have a specific organizational structure and procedures to perform and document laboratory work. The objective is not only quality of data but also traceability and integrity of data. But the biggest difference between GLP and Non-GLP work is the type and amount of documentation. For a GLP inspector it should be possible to look at the documentation and to easily find out who has done a study,? how the experiment was carried out, which procedures have been used, and whether there has been any problem and if so how it has been solved. All routine work should follow written standard operating procedures (SOP). Facilities such as laboratories should be large enough and have the right construction to ensure the integrity of a study, for example, to avoid cross contamination Test and control articles should have the right quality and instruments should be calibrated and well maintained? People should be trained or otherwise qualified for the job Raw data and other data should be acquired, processed and archived to ensure integrity of data. GMP(Good Manufacture Practice) 药品生产质量管理规 GMP refers to the Good Manufacturing Practice Regulations promulgated by the US Food and Drug Administration under the authority of the Federal Food, Drug, and Cosmetic Act These regulations, which have the force of law, require that manufacturers, processors, and packagers of drugs, medical devices take proactive