药品安全（Drug safety）.docVIP

药品安全（Drug safety） Drug safety knowledge test First, fill in the blanks 1, drug production quality management standards is the pharmaceutical production and quality management of basic standards. Key processes affecting product quality raw materials production process, suitable for the production of pharmaceutical preparations. 2, drug production enterprise shall establish production and quality management organization. All institutions and personnel responsibilities should be clear, and compatible with a certain number of drug production and have professional knowledge, experience and ability to organize production management personnel and technical personnel. The person in charge of the 3 pharmaceutical production enterprises in charge of pharmaceutical production management and quality management of the pharmaceutical or related professional college education, the pharmaceutical production and quality management experience, is responsible for the implementation of this standard and the quality of products. 4, engaged in drug production at all levels of personnel training and assessment according to quality standards pharmaceutical production requirements. 5, the pharmaceutical producing enterprises must have clean production environment; factory floors, roads and transportation should not cause pollution of drug production; the overall layout of production, living and ancillary areas should be reasonable, not interfere with each other. 6, entering the clean room (area) of the air to be purified, and according to the requirements of the production process of clean air level. Clean room (area) the number of microorganisms and dust particles in the air should be monitored regularly, monitoring results should be documented. 7 buildings and facilities, the production of penicillin high sensitizing drugs must be used independently, packing room should remain relatively negative pressure, exhaust gas to the outside of the purification treatment and should meet the requir