1. Purpose: Standardize the drug acceptance process to ensure that the quality and quantity of drugs entering the store are accurate.
2. Scope: Drug purchase and sales return acceptance work
3. Responsible person: Acceptance inspector
4. Content
4.1 All drugs must pass the acceptance inspection before they can be put into storage, displayed and sold in pharmacies. The acceptance of purchased drugs is the responsibility of the pharmacy acceptance inspector.
4.2 Inspection and acceptance of purchased drugs:
4.2.1 The inspector should conduct inspection of the incoming drugs one by one based on the contents of the "accompanying the goods list" and the purchase record. Batch acceptance.
4.2.2 The acceptance of drugs should be carried out in the area to be inspected and accepted in a timely manner within the specified time limit. General medicines should be accepted within half a working day after arrival, and medicines that require refrigeration should be accepted within 2 hours after arrival.
4.2.3 During acceptance, the packaging, labels, instructions and relevant supporting documents of the drugs should be inspected one by one in accordance with relevant laws and regulations;
① Labels of drug packaging The attached instructions should contain the name and address of the manufacturer, as well as the generic name, specifications, approval number, product batch number, production date, validity period, etc. of the drug. The label or instructions should also include the ingredients, indications or functions, usage, dosage, contraindications, adverse reactions, precautions, storage conditions, etc. of the drug;
② Acceptance of the product in the entire drug package Certificate of conformity;
③ When accepting external medicines, there must be prescribed warning instructions on the packaging labels or instructions. Prescription drugs and over-the-counter drugs are managed according to the classification requirements, and labels and instructions have corresponding warnings or warnings; the packaging of over-the-counter drugs has the proprietary mark "OTC" stipulated by the state;
④ The accepted Chinese medicine pieces should be packaged and Comes with a quality mark. Each package of traditional Chinese medicine pieces should be marked with the product name, production company, production date, etc. Chinese medicine pieces that are subject to approval number management should also be marked with the drug approval number;
⑤ Acceptance of imported drugs, both inside and outside The label of the package should indicate the name, main ingredients and registration certificate number of the drug in Chinese, and its smallest sales unit should have Chinese instructions. Imported drugs should be inspected and accepted with the "Imported Drug Registration Certificate" and "Imported Drug Inspection Report" or "Imported Drug Customs Clearance Form"; imported preventive biological products and blood products should have a copy of the "Biological Products Import Approval"; imported medicinal materials should have A copy of the "Approval Document for Imported Medicinal Materials";
⑥ When accepting the first batch of varieties, there should be a drug factory inspection report with the same batch number as the first batch of arriving drugs.
4.2.4 Sampling inspection of drugs for acceptance should be carried out in accordance with regulations, and the samples taken for acceptance should be representative. For the entire package of medicines sampled for acceptance, an obvious acceptance sampling mark should be affixed after the acceptance inspection is completed, and the packaging should be restored and sealed.
4.2.5 The validity period should be checked when accepting drugs. Generally, drugs with a validity period of less than 6 months shall not be put into the warehouse.
4.2.6 If drugs with quality problems are found during acceptance, the inspector should promptly fill in the "Drug Rejection Report Form", report it to the quality manager, and return it to the supplier.
4.2.7 When the product name, specification, batch number, manufacturer or quantity of the drug does not match the "accompanying the goods list", the pharmacy inspector should indicate and record it on the "accompanying the goods list" , and notify the supplier. Corrections will be made after verification and confirmation by the supplier.
4.2.8 The drugs that pass the acceptance inspection are handed over to the warehouse keeper for storage or to the salesperson of each counter group for classification and placement according to the drug display and storage requirements.
4.2.9 The inspector should prepare the "Drug Purchase Quality Acceptance Record" and sign it, stamp it with an acceptance seal, and indicate the date of acceptance. The record content includes supplier unit, quantity, arrival date, product name, dosage form, specification, approval number, batch number, manufacturer, validity period, quality status, acceptance conclusion and acceptance personnel, etc. File them on a monthly basis, store them in a centralized manner, and keep them as required until 1 year beyond the validity period of the drug, but not less than 2 years.
4.3 Acceptance of sold and returned drugs
4.3.1 When sold and returned drugs, the salesperson must find out whether the returned drugs were sold by the pharmacy, including checking the invoice or Computer receipt, purchase time, product name, specifications, manufacturer, quantity, batch number, etc. After it is confirmed that the medicines are sold by this pharmacy, the acceptance will be carried out by the acceptance inspector. If not, it will not be returned.
4.3.1 The returned drugs must be inspected for quality acceptance by the inspector in accordance with the acceptance standards for purchased drugs. Those with acceptable quality will continue to be displayed for sale, and those that fail will not be returned.
4.3.2 The inspector shall fill in the "After-sales Return Processing Record" as required and keep the record until 1 year after the drug's validity period, but not less than 2 years