The sales records of pharmaceutical retail enterprises shall be kept for at least 5 years.
Enterprises should sell drugs to legal purchasing units, and verify the purchasing unit’s certification documents and the identity certificates of purchasing personnel and delivery personnel to ensure that the flow of drug sales is true and legal. Enterprises should strictly review the production scope, business scope or diagnosis and treatment scope of the purchasing unit, and sell drugs according to the corresponding scope. Enterprises selling medicines must issue invoices truthfully and ensure that the invoices, accounts, goods, and payments are consistent.
Records only refer to various quality records involved in quality management work. The format of quality records shall be uniformly reviewed and approved by the person in charge of quality. Quality records shall be legible, correct and complete. Quality records shall be properly kept to prevent damage and loss. .
Legal basis
"Good Manufacturing Practice for Pharmaceutical Products"
Article 42 Records and vouchers shall be kept for at least 5 years. Records and vouchers of vaccines and specially managed drugs are kept in accordance with relevant regulations. Article 39 Enterprises should establish relevant records such as drug procurement, acceptance, maintenance, sales, warehouse review, post-sale returns and purchases and exits, transportation, storage and transportation temperature and humidity monitoring, and disposal of unqualified drugs, so as to be true, complete, and accurate , effective and traceable. Article 40 When recording data through the computer system, relevant personnel should follow the operating procedures and log in with authorization and password before entering or reviewing the data; changes to the data should be reviewed by the quality management department and carried out under its supervision. The change process Records should be kept. Article 41 Written records and vouchers must be filled in in a timely manner and must be written clearly and must not be altered or torn at will. If the record is changed, the reason, date and signature should be indicated, and the original information should be kept clear and legible. Article 68 When purchasing medicines, purchase records must be established. Procurement records should include the generic name, dosage form, specifications, manufacturer, supplier, quantity, price, purchase date, etc. of the drug. When purchasing Chinese herbal medicines and Chinese herbal medicine pieces, the place of origin should also be indicated. Article 69: In the event of special circumstances such as disasters, epidemics, emergencies or clinical emergency treatment, and other situations that comply with relevant national regulations, enterprises may purchase and sell drugs through direct transfer, and the purchased drugs will not be placed in the enterprise's warehouse. Send directly from the supplier to the purchasing unit, and establish special purchasing records to ensure effective quality tracking and traceability.