1, Internet drug trading
1)Provide trading services to individual consumers enterprise conditions: retail chain message service qualification, trading security variety management system, keep trading consulting records ability, distribution system trading service function, device specialists licensed pharmacist consulting.
2)Approval of the main body: the national bureau of the approval of the birth of the medical treatment between the national bureau of the approval of the birth of the approval of the provincial bureau outside the retail chain to the individual provincial bureau.
2, the circulation of drugs
1)Sales vouchers: *** have the name of the drug, manufacturer, batch number, quantity, price.
2)Drug manufacturers, wholesale enterprises, multi-supply units, medical institutions purchase records multi-dose, specifications, date of manufacture, expiration date, approval number, supply units, date of purchase.
3, drug management
1) color coding classification: zero goods to be issued qualified green, to be returned to the yellow unqualified red.
2)Retail quality management system: a report two audit; two guarantee three drugs; four quality six links.
Note: Report: adverse reaction report;
Audit: first enterprise and collection of varieties;
Security: health and personnel health;
Quality: quality responsibility, quality accidents, quality of information, quality of service;
Drugs: split drugs, special management drugs, traditional Chinese medicine tablets;
Links: purchase, acceptance, storage, display, maintenance, sales.
3) cancellation of the "Drug License" circumstances: expiration of the license is not renewed, the closure of the license is invalid, the matter can not be applied, revocation of the license.
4)Business category: prescription or non-prescription drugs, Class B non-prescription drugs.
5) "Drug License Management Measures" applies to the "Drug License" of the issuance, replacement, change, supervision and management, that is? Issue and exchange change supervision? 6)The scope of drug business includes: hemp essence poison biological biochemistry, Chinese herbal medicine tablets into medicine, chemogenetic antibiotic preparations.
4, recall management
1)Serious harm to the first level of recall, temporary reverse harm to the second level of recall, harmless other causes of the third level of recall. 2)Notification of the first two or three levels of recall123, the report of the first two or three levels of recall137.
5, the management of drug production
1)The batch of division: Injection the same dispensing tank; powder injection with the same batch of raw materials, lyophilized powder injection with the same batch of liquid with the same lyophilization equipment; solid, semi-solid preparations: the same mixing equipment before molding or dispensing; liquid preparations; filling (sealing before the final mixing of liquids; i.e., the ? Size injection dispensing tank liquid, powder injection raw materials freeze-drying and freezing set up, liquid filling mixed liquid, solid and semi-solid molding mixing set up?). .
2) production management documents: post standard operation process production records.
3)Quality management documents: approval of the quality standard stabilization inspection records.
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