the state council office of health care reform published answers to the reporters on &qute;twelfth five-uefa欧洲杯

the state council office of health care reform published answers to the reporters on &qute;twelfth five-year plan&qute;

addtime:jul.06, 2012      source:admin

    in view of the frequent change of the current drug production enterprises quality attorney, which has affected the quality of enterprise management, anhui provincial fda further strengthens the management of quality attorney of drug production enterprises and standardizes, the recorded registration and change behavior of the quality attorney.

   1.the basic condition for the quality attorney. the quality attorney of pharmaceutical producing enterprise shall meet the following conditions: abide by the law, adhere to the principle, seek truth from facts, be honest and trustworthy; expertly master and correctly implement national laws, rules and regulations, correctly understand and grasp and implement the relevant provisions of gmp; possess a pharmacy or related bachelor degree (or intermediate professional titles or licensed pharmacist qualification), at least have 5 years'experience engaged in pharmaceutical production and quality management; understand and be familiar with production process and quality standard, have more than 1 year experience of the enterprise or other enterprise production process control and quality inspection; be familiar with pharmaceutical production and quality management work, have the professional skills of guiding or supervising enterprise departments to implement the provisions of the drug gmp and the ability to solve practical problems; have the knowledge of legal regulations, business knowledge and occupation morality corresponding to the quality attorney performing the duties; have the ability to make the correct analysis, judgement and reasoning of practical problems during the pharmaceutical production and quality management, have the good communicating ability and language expressing ability; have no bad record of violation of the related drug administration laws and regulations; enterprise full-time staff, healthy without contagious disease; have corresponding professional knowledge background for those who are engaged in biological products, blood products, vaccines and radioactive pharmaceuticals and other special categories of drug production and have more than 3 years'professional experience.

   2.pharmaceutical production enterprises should take effective measures to ensure the relative stability of the quality attorney, no change within a year, and at the same time, in principle province bureau no longer accepted the same personnel within 1 year more than once for their registration application about quality attorney. order to confirm the quality attorney whether to have the relevant laws and regulations and professional knowledge, province bureau will provide free test opportunity for them, organize experts to prepare a test question bank, and in the last ten-day period of each bimonthly, will have the test for them in the province review and certification center.

   4.the enterprise should, within 5 working days after the legal representative and the quality asttorney both signed agreement, present the archival filing materials to the local food and drug administration to verify and with comments submit the provincial fda; and in 15 working days for archival filing confirmation, register in the "drug production license" copy.

   5.province bureau will regularly organize training for the quality attorney. the training will be organized about the laws and regulations, professional knowledge, occupation morality and other aspects for the qualified personnel who meet the pharmaceutical producing enterprises quality attorney and have the corresponding assessment and recording. enterprise quality attorney and all of its entrusted who receive quality management responsibilities should take the initiative to participate in the various training organized by the food and drug regulatory departments, strengthen the updating of knowledge, and continuously improve the operational and policy level.