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What are the requirements for special drugs in the process of acceptance?
1. Double acceptance and double audit. Unqualified acceptance, shall not be put into storage and sales.

2. At the time of acceptance, in addition to the acceptance items of ordinary drugs, it is also necessary to check the special signs printed on the internal and external packaging, and the arrival acceptance record sheet shall be filed separately until it exceeds the validity period of drugs by one year and shall not be less than three years.

3, should set up a counter, double, double lock management. Should be a strong sense of responsibility, serious and responsible work, skilled custodian.

4. We should adhere to the daily contact, monthly inventory and the coincidence rate of accounts and goods reached 100%. When problems are found, they should be reported step by step immediately and investigated and handled in time.

5. It must be delivered out of the warehouse with legal and valid delivery vouchers. If there is no valid certificate, it shall not be delivered out of the warehouse, and the sales and delivery audit records shall be kept.

6, must be packaged separately, and shall not be mixed with general drugs.

7. The report of loss shall be destroyed according to the management system of narcotic drugs and psychotropic drugs of category I. ..

Special drugs refer to drugs that the state has formulated a legal system and implemented stricter control than other drugs.

Extended data

"Good Quality Management Practice for Pharmaceutical Trading"

Article 72 An enterprise shall, in accordance with the prescribed procedures and requirements, receive and accept drugs that arrive in batches to prevent unqualified drugs from being put into storage.

Article 73 When drugs arrive, the consignee shall verify whether the mode of transportation meets the requirements, and check the drugs with the attached bills (tickets) and purchase records to ensure that the tickets, accounts and goods are consistent.

The attached bill (ticket) shall include the general name, dosage form, specification, batch number, quantity, receiving unit, receiving address, delivery date and other contents of the supplier, manufacturer and drug, and shall be stamped with the original seal of the special seal for drug delivery of the supplier.

Article 74 After the arrival of refrigerated and frozen drugs, the mode of transportation, temperature records during transportation, transportation time and other quality control conditions shall be inspected and recorded. Those that do not meet the temperature requirements shall be rejected.

Article 75 The consignee shall, according to the requirements of variety characteristics, place the drugs that meet the requirements of receiving goods in the corresponding area to be inspected, or set up a status sign to inform the receipt. Cold storage and frozen drugs should be tested in cold storage.

Article 76 When accepting drugs, the inspection report of the same batch number shall be checked according to the batch number of drugs. If the supplier is a wholesale enterprise, the inspection report shall be stamped with the original of its special seal for quality management. The inspection report can be transmitted and saved in the form of electronic data, but its legality and effectiveness should be guaranteed.

Article 77 An enterprise shall, in accordance with the provisions on acceptance, conduct batch-by-batch sampling acceptance of drugs that arrive each time, and the samples taken shall be representative:

(1) At least one minimum package shall be inspected for drugs of the same batch number, but the manufacturer may not open the minimum package if it has special quality control requirements or the opening of the minimum package may affect the quality of drugs;

(two) abnormal packaging, such as damage, pollution, leakage, broken seals, odd parts, LCL and other commodities, should be unpacked and consigned to the minimum packaging;

(3) Raw materials with complete packaging and sealing, and biological products subject to batch issuance management do not need unpacking inspection.

Article 78 Inspectors shall inspect and check the appearance, packaging, labels, instructions and relevant supporting documents of the sampled drugs one by one. After acceptance, the complete sample should be put back in the original packaging box, sealed and marked.

Article 79 Drugs under special management shall be inspected and accepted in special warehouses or special areas in accordance with relevant regulations.

Article 80 Acceptance records shall be kept, including common name, dosage form, specification, approval number, batch number, production date, validity period, manufacturer, supplier, arrival quantity, arrival date, qualified quantity and acceptance results. The acceptance personnel shall sign the name and acceptance date on the acceptance record.

The acceptance record of Chinese herbal medicines shall include the name, place of origin, supplier, arrival quantity, qualified quantity, etc. The acceptance record of Chinese herbal pieces shall include the name, specification, batch number, origin, production date, manufacturer, supplier, arrival quantity, acceptance quantity, etc., and the approval number shall also be recorded for Chinese herbal pieces subject to the approval number management.

Unqualified acceptance shall also indicate unqualified items and disposal measures.

Eighty-first enterprises should establish inventory records, and drugs that pass the inspection should be registered and put into storage in time; Unqualified acceptance, shall not be put into storage, and handled by the quality management department.

Article 82 Where an enterprise directly mixes drugs in accordance with the provisions of Article 69 of this Law, it may entrust a purchasing unit to conduct drug acceptance. The purchasing unit shall accept drugs in strict accordance with the requirements of this specification, and establish a special record for the acceptance of drugs directly transferred. On the day of acceptance, the relevant information of the acceptance record shall be transmitted to the direct dispatching enterprise.

Baidu encyclopedia-special drugs

Baidu Encyclopedia —— Quality Management Standard of Drug Business