CFDA: GSP on site inspection guidelines revised!

Source: Drugstore manager 2016-12-19 recently, CFDA official website released the guiding principles for on-site inspection of quality management specifications for drug distribution (Revised Version) The revised version revised and improved the relevant provisions of the first part of "drug wholesale enterprises" and the second part of "drug retail enterprises", and added the third part of "in vitro diagnostic reagent (drug) trading enterprises" According to the judgment principle of supervision and inspection results, as long as one serious defect appears in the inspection items, it can be judged as a serious violation of the drug trade quality management specifications, and the certificate of drug trade quality management specifications certification can be revoked Judgment of supervision and inspection results: after sorting out, the inspection items for serious defects of drug wholesale enterprises, drug retail enterprises and in vitro diagnostic reagent (drug) trading enterprises in the revised draft are as follows: drug wholesale enterprises * * 00201 The enterprise shall take effective quality control measures in the purchase, storage, sale and transportation of drugs to ensure the quality of drugs, and establish a drug traceability system in accordance with the relevant requirements of the state to achieve drug traceability **00401 pharmaceutical trading enterprises shall operate according to law **00402 pharmaceutical trading enterprises shall adhere to the principle of honesty and trustworthiness and prohibit any false or deceptive behavior **03101 the quality management system documents formulated by the enterprise shall be complete and conform to the actual situation of the enterprise, including the quality management system, responsibilities of departments and posts, operating procedures, files, reports, records and vouchers, etc **04902 where vaccines are stored, more than two independent refrigerators shall be provided **05805 the enterprise computer system shall have application software and relevant databases that meet the requirements of the specification and the actual needs of enterprise management **06101 when purchasing drugs, an enterprise shall determine the legal qualification of the supplier, determine the legitimacy of the purchased drugs, and verify the legal qualification of the sales personnel of the supplier **06601 when purchasing drugs, the enterprise shall ask for the invoice from the supplier **06701 the name, amount and product name of the purchasing and selling unit on the invoice shall be consistent with the payment direction, amount and product name, and shall correspond to the contents of the financial accounts **09101 an enterprise shall truthfully issue an invoice for the sale of drugs so that the invoice, account, goods and money are consistent (standard blue content is new item) drug retail enterprise * * 00201 shall take effective quality control measures in drug purchase, storage, sales, transportation and other links to ensure drug quality, and establish drug traceability system in accordance with relevant national requirements to achieve drug traceability **00401 pharmaceutical trading enterprises shall operate according to law **00402 pharmaceutical trading enterprises shall adhere to the principle of honesty and trustworthiness and prohibit any false or deceptive behavior **12101 an enterprise shall have business conditions suitable for its business scope and scale, including organizational structure, personnel, facilities and equipment, quality management documents, and shall set up a computer system in accordance with regulations **14504 those engaged in refrigerated drugs have special refrigerated equipment **14807 those engaged in refrigerated drugs shall have special equipment suitable for their varieties and scale of operation **15209 when purchasing drugs, the enterprise shall ask for the invoice from the supplier **15211 the name, amount and product name of the purchasing and selling unit on the invoice shall be consistent with the payment direction, amount and product name, and shall correspond to the contents of the financial accounts (the content of the standard blue is the new item) the enterprise **00201 engaged in the business of in vitro diagnostic reagents (drugs) shall take effective quality control measures in the links of drug procurement, storage, sales, transportation, etc to ensure the quality of drugs, and establish a drug traceability system in accordance with the relevant requirements of the state to realize drug traceability **00401 the enterprise shall operate according to law **00402 the enterprise shall adhere to the principle of honesty and trustworthiness and prohibit any false or deceptive behavior **The quality management personnel of 02101 enterprise shall be at least one person in charge of the inspector, with a bachelor's degree or above in laboratory related major and more than 3 years of in vitro diagnostic reagent inspection work experience, able to independently solve the quality problems in the business process **03101 the quality management system documents formulated by the enterprise shall conform to the actual situation of the enterprise, including the quality management system, department and post responsibilities, operation procedures, files, reports, records and vouchers, etc **05805 the enterprise computer system shall have application software and relevant database that meet the actual needs of enterprise management **06101 when purchasing in vitro diagnostic reagents, the enterprise shall determine the legal qualification of the supplier, determine the legitimacy of the purchased products, and verify the legal qualification of the sales personnel of the supplier **06601 when purchasing in vitro diagnostic reagents, the enterprise shall ask for the invoice from the supplier **09101 enterprises selling in vitro diagnostic reagent products shall truthfully issue invoices, so that the invoices, accounts, goods and funds are consistent.