Acceptance records should be kept for accepted drugs, including the drug’s generic name, dosage form, specifications, approval number, batch number, production date, validity period, manufacturer, supplier, arrival quantity, and arrival date. , acceptance qualified quantity, acceptance results, etc. The acceptance personnel shall sign their name and acceptance date on the acceptance record.

The acceptance record of Chinese medicinal materials shall include the product name, place of origin, supplier, quantity of arrival, quantity that has passed the acceptance inspection, etc. The acceptance record of traditional Chinese medicine prepared pieces should include product name, specifications, batch number, place of origin, production date, manufacturer, supplier, quantity of arrival, quantity that has passed the acceptance inspection, etc. Chinese medicine prepared pieces that are subject to approval number management should also record the approval number.

If the acceptance fails, the unqualified matters and disposal measures should also be noted.

Extended information

Receipt and acceptance

1. Enterprises should receive and accept the incoming drugs batch by batch in accordance with the prescribed procedures and requirements to prevent Unqualified drugs are put into storage.

2. When the medicine arrives, the receiving personnel should verify whether the transportation method meets the requirements, and check the medicine against the accompanying invoice (invoice) and the purchase record to ensure that the invoice, account, and goods are consistent.

3. When refrigerated and frozen medicines arrive, key inspections and records should be made on their transportation methods, temperature records during transportation, transportation time and other quality control conditions. Products that do not meet the temperature requirements shall be rejected.

4. The receiving personnel should place the drugs that meet the receiving requirements in the corresponding areas to be inspected according to the variety characteristics, or set status signs to notify acceptance. Refrigerated and frozen medicines should be kept in cold storage pending inspection.

5. When accepting drugs, the inspection report of the same batch number should be checked according to the drug batch number. If the supplier is a wholesale enterprise, the inspection report shall be stamped with its original quality management seal. The transmission and storage of the inspection report can be in the form of electronic data, but its legality and validity should be ensured.

6. In accordance with the acceptance regulations, enterprises should conduct sampling and acceptance of each arriving drug batch by batch, and the samples taken should be representative.

7. The acceptance personnel should inspect and verify the appearance, packaging, labels, instructions and relevant supporting documents of the sampled drugs one by one; after the acceptance, the intact samples should be returned to the original packaging box. , sealed and labeled.

8. Drugs under special management shall be inspected and accepted in special warehouses or special areas in accordance with relevant regulations.

9. Acceptance records should be kept for drugs to be accepted, including the common name, dosage form, specifications, approval number, batch number, production date, validity period, manufacturer, supplier, arrival quantity, and arrival date of the drug. Delivery date, acceptance quantity, acceptance results, etc. The acceptance personnel shall sign their name and acceptance date on the acceptance record.

The acceptance record of Chinese medicinal materials shall include the product name, place of origin, supplier, arrival quantity, acceptance quantity, etc. The acceptance record of traditional Chinese medicine prepared pieces should include product name, specifications, batch number, place of origin, production date, manufacturer, supplier, quantity of arrival, quantity that has passed the acceptance inspection, etc. Chinese medicine prepared pieces that are subject to approval number management should also record the approval number.

If the acceptance fails, the unqualified matters and disposal measures should also be noted.

10. Enterprises should establish inventory records, and drugs that pass the acceptance inspection should be put into the warehouse for registration in a timely manner; drugs that fail the acceptance inspection must not be put into the warehouse and will be handled by the quality management department.

11. If an enterprise conducts direct transfer of drugs, it can entrust the purchasing unit to conduct drug acceptance. Purchasing units shall strictly comply with the requirements of this specification to accept drugs and establish special acceptance records for directly adjusted drugs. On the day of acceptance, the relevant information of the acceptance record shall be transmitted to the direct adjustment enterprise.

Baidu Encyclopedia-Pharmaceutical Goods Management Practices