Shaanxi trial quality credit rating classification for pharmaceutical production enterprises
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Last Update: 2020-05-12
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Source: Internet
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Author: User
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Medicines Network June 16 Tha of the Pharmaceutical Network to promote the construction of the integrity system of pharmaceutical production enterprises, the Provincial Food and Drug Supervision Administration has issued the "
Shaanxi Province pharmaceutical production enterprises quality credit rating assessment and classification management measures (trial), the Measures put forward for the drug production enterprises to test quality credit rating classification management the Measures clearly put forward, the province's drug production enterprises to carry out credit rating classification, a, B, C, D four levels, respectively, on behalf of trustworthiness, basic trustworthiness, breach of trust, serious breach of trust Among them, the quality credit rating assessed as A-class enterprises, to comply with the drug GMP certification; Class B enterprises to meet the drug GMP certification, no quality accidents within two years If the defects found in the enterprise sinat through various inspections are not corrected within the prescribed time limit, a quality accident occurred within the last two years or a product that has been ordered to be recalled due to quality factors, and if the production violation is punished for violating the law, the quality credit level of the act of being warned more than twice in a row for the same illegal act shall be rated as C-grade; Enterprises that find serious defects in various types of inspections, have major drug quality accidents, enter the "black list" of safety of drugs, refuse to obstruct law enforcement officials from conducting supervision and inspection in accordance with the law, sampling or refusing to cooperate with law enforcement officials in conducting case investigations in accordance with the law, and enterprises that violate the drug supervision and management laws and regulations that constitute a crime are rated D-grade. the Measures provide that the enterprise quality credit rating is subject to dynamic identification, once a year The regulatory authorities shall, according to the credit rating, carry out the classification supervision of the of drugs and the production enterprises ,
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