药品GMP复习题（Drug GMP review questions）.docVIP

药品GMP复习题（Drug GMP review questions） Drug GMP (revised 2010) training review questions (Part 1) It consists of the first chapter, the second chapter, the third chapter, the sixth chapter, the seventh chapter, the eighth chapter, the ninth chapter, the tenth chapter, the eleventh chapter, the fourteenth chapter, the twelfth chapter, the thirteenth chapter, the second chapter, the second chapter, the second chapter, the second chapter and the appendix Fill in the blanks 1, drug GMP (revised in 2010) a total of fourteen chapters, the 313 chapter respectively: Fourteen general principles, quality management, organization and personnel, buildings and facilities, equipment, materials and products, validation and verification, file management, production management, quality control and quality assurance, commissioned the production and Inspection Commission, product delivery and recall self checking, and supplementary provisions. 2, the drug GMP (2010 Revision) promulgated by the Ministry of health, the effective date is March 1, 2011. 3, the existing drugs production enterprise of blood products, vaccines, injection of sterile drug production before December 31, 2013 in conformity with GMP (revised in 2010) 4, the drug GMP (2010 Revision) certification evaluation methods include on-site inspection, evaluation and approval, comprehensive evaluation 5, the key personnel of enterprise refers to: quality authorized person, enterprise leader, production management person in charge, quality management person in charge 6. The quality assurance authority is responsible for the release of the product 7. Personnel engaged in direct contact with pharmaceuticals shall undergo health examination before they start their posts and undergo at least one health check every year thereafter. 8, visitors and untrained personnel may not enter the production area and quality control areas, if the special circumstances need to enter, they should advance personal hygiene, change clothes and other