2, GSP certification inspection of retail enterprises *** 109 items, of which 34 key items (articles before the addition of "*"), 75 general items
3, on-site inspection, should be listed in the project and its coverage of the content of the comprehensive inspection, and item by item to make a positive, or negative assessment. All incomplete, incomplete items, known as defective items; key items failed for serious defects; general items failed for general defects.
4, the results of the assessment: *5801 enterprises should follow the legally approved mode of operation and business scope of business activities. 5802 enterprises should be in the business store in a prominent position hanging drug business enterprise license, business license and with the requirements of practitioners in line with the practice of the proof of practice. 5901 the main person in charge of the enterprise to the enterprise business of the quality of pharmaceuticals is responsible for the leadership of the quality of the leading responsibility. *6001 Enterprises should set up quality management organization or full-time quality management personnel, specifically responsible for enterprise quality management.6002 Quality management organization or full-time quality management personnel shall be responsible for the implementation of national laws, regulations and administrative regulations on drug quality management.6003 Quality management organization or full-time quality management personnel shall be responsible for the drafting of the enterprise drug quality management system, and guide, supervise the implementation of the system.6004 Quality management organization or full-time quality management personnel shall be responsible for the drafting of the enterprise drug quality management system, and guide, supervise the implementation of the system. The quality management organization or full-time quality management personnel shall be responsible for the quality audit of the first enterprise.6005 The quality management organization or full-time quality management personnel shall be responsible for the quality audit of the first varieties.6006 The quality management organization or full-time quality management personnel shall be responsible for the establishment of the quality file of the drugs operated by the enterprise, including the quality standard.6007 The quality management organization or full-time quality management personnel shall be responsible for the inquiries on the quality of the drugs and the quality of the drugs. management personnel shall be responsible for the inquiry of the quality of the drugs and the investigation, treatment and report of the quality accidents or quality complaints of the drugs.6008 The quality management organization or the full-time quality management personnel shall be responsible for the management of the acceptance of the drugs.6009 The quality management organization or the full-time quality management personnel shall be responsible for guiding and supervising the quality of the drugs in the storage, maintenance and transportation.6010 The quality management organization or the full-time quality management personnel shall be be responsible for auditing the quality of unqualified drugs and supervising the process of handling unqualified drugs.6011 The quality management organization or full-time quality management personnel shall be responsible for collecting and analyzing information on the quality of drugs.6012 The quality management organization or full-time quality management personnel shall be responsible for assisting in carrying out the education or training of the enterprise's employees on the quality management of drugs. *6101 The relevant quality management system to be formulated by the enterprise shall include: the quality responsibility of the relevant business and management positions; the management regulations on the purchase of drugs; the management regulations on the acceptance of drugs; the management regulations on the storage of drugs; the management regulations on the display of drugs; the management regulations on the maintenance of drugs; the regulations on the audit of the first enterprise and the first species; the regulations on the sale of drugs and the management of prescription; the regulations on the management of split drugs; the management regulations on special management Provisions on the purchase, storage, custody and sale of drugs; provisions on the handling and reporting of quality accidents; provisions on the management of quality information; provisions on the reporting of adverse drug reactions; provisions on the management of various hygiene management systems; provisions on the management of the health status of personnel; provisions on the management of the quality of service; and the enterprises dealing with the management of Chinese herbal medicinal tablets shall have provisions in line with the management of the purchase, sale and storage of Chinese herbal medicinal tablets. *6102 Enterprises shall conduct regular inspections and assessments of the various management systems and establish records. *6201 large and medium-sized enterprises quality management work should be responsible for pharmacists (including pharmacists and Chinese pharmacists) above the technical title; small enterprises quality management work should be responsible for pharmacists (including pharmacists and Chinese herbalists) above the technical title. *6301 pharmaceutical retail prescription reviewers should be licensed pharmacists or pharmacists above (including pharmacists and Chinese pharmacists) professional and technical titles. *6401 enterprises engaged in quality management personnel shall have a pharmacist (including pharmacists and Chinese pharmacists) above the technical title, or with secondary school education in pharmacy or related professions (referring to medicine, biology, chemistry, etc.).6402 enterprises engaged in the acceptance of medicines, as well as salespersons shall have a high level of literacy (including) or above. If junior high school education, must have more than 5 years of experience in the pharmaceutical business.6501 enterprises engaged in quality management and acceptance of staff and salespersons should be professional or job training, and by the municipal level (including) above the drug supervision and management department exams, issued by the certificate of post qualification before being allowed to take up their duties.6502 The state has the employment of the entry provisions of the post, the staff need to be through the vocational skills assessment and obtain a vocational qualification certificate before being allowed to work. and obtain the vocational qualification certificate before taking up the post.6503 Enterprises engaged in quality management personnel, each year should be subject to provincial drug supervision and management department of the organization of continuing education.6504 Enterprises engaged in acceptance, maintenance, measurement, etc., should be regularly accepted by the enterprise organization of continuing education.6505 Enterprises should be the establishment of the personnel of the continuing education file. *6506 Enterprises engaged in quality management personnel shall be on duty, shall not work part-time in other units.6601 Enterprises shall annually organize quality management, drug acceptance, maintenance, custody, salespersons and other personnel in direct contact with the drugs for health checks, and establish health records.6602 Personnel found to be suffering from mental illnesses, infectious diseases and other diseases that may contaminate the medicines shall be promptly transferred out of their workplaces.6603 Enterprises shall establish health files for their personnel. *6701 Enterprises should have business premises and drug warehouses appropriate to the scale of the operation of drugs. Large-scale enterprise business premises area of not less than 100 square meters, the warehouse area of not less than 30 square meters; medium-sized enterprise business premises area of not less than 50 square meters, the warehouse area of not less than 20 square meters; small-scale enterprise business premises area of not less than 40 square meters, the warehouse area of not less than 20 square meters.6702 Enterprise business premises and pharmaceutical warehouses should be environmentally clean and free of pollutants.6703 Enterprise Business premises, warehouses, office life and other areas should be separated.6704 Business premises, business shelves, counters are available, sales cabinets marked conspicuously.6705 The floor and walls in the warehouse are flat and clean. *6801 Enterprises should be configured to store special management of drugs in special cabinets, as well as custody of equipment, tools and so on. *6802 Enterprises should be configured according to the need to meet the requirements of the characteristics of drugs at room temperature, cool and refrigerated storage equipment.6803 Enterprises should be configured with the necessary drug acceptance, maintenance equipment.6804 Enterprises should be configured to regulate the temperature and humidity equipment.6805 Enterprises should be configured to maintain a certain distance between the drugs and the ground.6806 Enterprises should be configured with the drugs to dustproof, moisture-proof, anti-pollution and insect-proof, Anti-rodent, anti-mold and other equipment.6807 enterprises operating Chinese medicine tablets, should be configured with the necessary equipment for prescription and prescription concoctions.6808 enterprises should be equipped with intact scales, as well as clean and hygienic medicine mixing tools, packaging supplies and so on. *7001 Enterprises shall purchase medicines on the premise of quality, purchase from legitimate enterprises, and audit the legality of the purchased medicines. *7002 Enterprises shall audit the legitimacy of the first enterprise and keep records.7003 Enterprises shall purchase drugs in accordance with the incoming quality management procedures that can guarantee the quality of drugs. *7004 Enterprises shall verify the legal qualifications of the sales personnel of the supply units that have business contacts with the enterprise.7005 Enterprises purchasing medicines shall sign purchase contracts with clear quality terms.7006 Enterprises purchasing medicines shall carry out the quality terms in the purchase contracts. *7007 Enterprises purchasing drugs under special management shall be carried out in strict accordance with the relevant national management regulations. *7101 Enterprises purchasing drugs should have legal bills, and establish purchase records in accordance with the provisions of the purchase, so that tickets, accounts and goods are consistent. Enterprise purchase records should be complete, including: name, dosage form, specifications, expiration date, manufacturer, supplier, quantity purchased, date of purchase, etc.7102 Enterprise purchase bills and records should be kept until more than one year beyond the expiration date of the drug, but not less than two years.7201 Enterprise contracts for the purchase of pharmaceuticals should be complete, and clearly define the quality terms. The purchase and sale contracts shall specify: the quality of the drugs meets the quality standards and relevant quality requirements; the drugs are accompanied by product certification; and the packaging of the drugs meets the relevant regulations and requirements for the transportation of goods. Purchase of imported drugs, the supply side should provide certificates and documents in line with the provisions. * 7301 Enterprises purchasing the first species should fill out the "first business drug approval form", drug quality audit, and by the enterprise quality management organization (personnel) and the competent leadership review and approval. The first varieties of legality and quality of the audit should include: verification of the approval number of drugs and quality standards, review of drug packaging, labeling, instructions, etc. Whether in accordance with the provisions of the performance of the drug, use, test methods, storage conditions and quality reputation, etc. 7302 enterprises should purchase the first varieties of the batch number of the quality of the drug inspection report. *7401 Acceptance personnel on the purchase of drugs, should be based on the original documents, in strict accordance with the relevant provisions of the batch-by-batch acceptance. Acceptance of drugs should be recorded, acceptance records record the supply unit, quantity, date of arrival, product name, specifications, approval number, production batch number, manufacturer, expiration date, quality status, acceptance conclusions and acceptance of the personnel and other items. *7402 Enterprises of special management of drugs, should implement a two-person acceptance system.7403 Acceptance records should be kept until more than one year beyond the expiration date of the drug, but not less than three years.7501 Acceptance of the quality of pharmaceutical products, should be carried out in accordance with the provisions of the appearance of the drug traits check.7502 Acceptance of the quality of pharmaceutical products, should be in accordance with the provisions of the inspection of drugs inside and outside of the packaging, labeling, manuals and labels and other items of content. The label of the package and the accompanying instructions should have the name and address of the manufacturer, the name, specification, approval number, batch number, date of production, expiration date, etc.; the label or instructions should also have the ingredients of the drug, indications or functions, usage, dosage, contraindications, adverse reactions, precautions, as well as storage conditions, etc. 7503 Drugs should be packaged with a certificate of conformity for each piece of the product. 7504 Special management of drugs, drugs for external use of the packaging of the label or instructions, with the required identification and warning instructions.7505 Prescription drugs and non-prescription drugs in accordance with the requirements of the classification and management, labels, instructions, with the appropriate warning or advice; non-prescription drug packaging with the state's proprietary logo.7506 Imported drugs and their packaging labels should be in Chinese to indicate the name of the drug, the main ingredients and the registration certificate number , and have Chinese instructions. *7507 acceptance of imported drugs, there should be in line with the provisions of the "Certificate of Registration of Imported Drugs" and "Imported Drugs Inspection Report" copy; imported precautionary biological products, blood products should be "import approval of biological products" copy; imported herbs should be "imported herbs approval" copy. The above approval documents should be stamped with the original seal of the quality management organization of the supply unit.7508 Chinese herbal medicines and Chinese herbal medicines should be packaged with the mark of quality. Each package, Chinese herbal medicines labeled name, origin, supply unit; Chinese medicine tablets labeled name, manufacturer, production date and so on. Implementation of document number management of Chinese herbal medicines and traditional Chinese medicine tablets in the package should be marked with the approval number.7601 The quality and packaging of the drugs displayed in the store should be in accordance with the provisions. *7701 Drugs shall be categorized for display and storage according to the dosage form or use as well as storage requirements. *7702 Prescription drugs and non-prescription drugs shall be displayed in separate cabinets. *7703 Drugs under special management shall be stored in accordance with the relevant national regulations.7704 Hazardous materials shall not be displayed. If display is necessary due to necessity, only substitutes or empty packages should be displayed.7705 The storage of dangerous goods should be managed and stored in accordance with the relevant state regulations.7706 Disassembled medicines should be centrally stored in a special cabinet for disassembled medicines and the labels of the original packages should be retained.7705 The storage of dangerous goods should be managed and stored in accordance with the relevant state regulations. *7707 The quality of Chinese medicine tablets should be reviewed before loading the bucket, and the wrong bucket or string of buckets should not be allowed to prevent mixing of medicines.7708 The positive name and characters should be written before the bucket of tablets.7709 The stacks of medicines should be left at a certain distance. The distance between the medicines and the walls and roof (beams) is not less than 30 centimeters, and the distance between them and the radiators or heating pipes of the storehouse is not less than 30 centimeters, and the distance between them and the ground is not less than 10 centimeters. *7710 Unqualified drugs should be stored in the unqualified products library (area), and have a clear sign. *7711 The confirmation, reporting, reporting loss, and destruction of unqualified drugs should have perfect procedures and records.7712 The cabinets and windows for displaying drugs should be kept clean and hygienic to prevent man-made contamination of the drugs.7713 Displayed drugs should be classified and neatly arranged according to the varieties, specifications, dosage forms, or uses, and the category labels should be placed accurately with clear handwriting.7801 The displayed drugs should be inspected and recorded on a monthly basis, and any quality problems found should be promptly dealt with. Quality problems found should be dealt with promptly.7802 The quality of stored drugs should be checked regularly and recorded. Drugs with near expiration dates, drugs prone to mold and mildew, and drugs prone to moisture dissolution shall have their inspection cycles shortened as appropriate. *7803 Enterprises should check whether the environment and storage conditions of drug display meet the specified requirements.7804 Enterprises should check all kinds of maintenance equipment.7805 Problems found in the inspection of display and storage of drugs should be reported to the person in charge of quality in a timely manner and dealt with as soon as possible.7806 Drugs found to be of doubtful quality in storage should not be put up for sale, and should be notified to the quality management organization or quality management personnel for processing.7807 Enterprises should notify the quality management organization or quality management personnel to deal with problems. management personnel for processing.7807 Enterprises should do a good job of monitoring and managing the temperature and humidity of the warehouse. The temperature and humidity of the warehouse should be recorded regularly once a day in the morning and once in the afternoon. *7808 Enterprises warehouse temperature, humidity beyond the prescribed range, should take timely regulatory measures, and be recorded.7809 When drugs are stored, they should be expiration date marking. For drugs near the expiration date, the expiration date statement should be filled out monthly.7901 Stock of drugs should be color-coded management. The uniform standard is: pending inspection of the drug library (area), returned drug library (area) is yellow; qualified products library (area) is green; unqualified drugs library (area) is red.8001 Sales of drugs should strictly comply with relevant laws, regulations and systems, and correctly introduce the performance of the drug, its use, contraindications and precautions. *8101 When selling drugs, prescriptions shall be reviewed and approved by a licensed pharmacist or a person with the title of pharmacist or above (including pharmacist and Chinese pharmacist) before they are dispensed and sold. *8102 The drugs listed in the prescription shall not be changed or substituted without authorization.8103 For prescriptions with contraindications to dispensing or excessive dosage, the dispensing and sale shall be refused, and, if necessary, corrections or re-signatures of the original prescribing physician shall be required before dispensing and sale. *8104 The personnel who review, dispense or sell the prescription shall sign or stamp the prescription.8105 Prescriptions shall be kept for inspection in accordance with the relevant regulations.8016 During business hours, a licensed pharmacist or pharmacist shall be on duty and shall wear a badge indicating his/her name, the licensed pharmacist, or his/her technical title, etc.8107 Prescription medicines shall not be sold without a prescription from a physician.8108 Prescription medicines shall not be sold without a prescription from a physician.8109 The prescription shall not be sold without a prescription from a physician.8101010 10. *8108 Prescription drugs shall not be sold on an open-shelf self-select basis.8109 Nonprescription drugs may be sold without a prescription. However, if requested by the customer, a licensed pharmacist or pharmacist shall be responsible for providing guidance on the purchase and use of the drugs.8110 Drugs shall not be sold by way of prize sales, attached drugs or gift sales.8111 The Chinese herbal medicinal tablets sold by the enterprise shall comply with the specification for infusion and be accurately measured.8112 The enterprise shall, in accordance with the state regulations on adverse drug reaction reporting system and the relevant system of the enterprise, pay attention to the collection of adverse drug reaction information provided by the enterprise. Enterprises shall pay attention to the collection of adverse reactions to medicines sold by them in accordance with the provisions of the relevant national system on reporting of adverse reactions and the relevant systems of the enterprises.8113 Enterprises shall report adverse reactions to the relevant departments in accordance with the regulations. *8201 The tools and bags used for the sale of medicines in pieces shall be clean and hygienic, and the name of the medicines, specifications, method of service, dosage and expiry date shall be written on the bags when they are sold. *8301 The sale of specially managed drugs shall be strictly in accordance with the relevant state regulations, with a limited supply of doctors' prescriptions stamped with the official seal of the medical unit, and sales and review personnel shall sign or stamp the prescription, which shall be kept for two years.8401 Enterprises shall provide consulting services in their retail premises, and guide their customers in the safe and rational use of medicines.8401 Enterprises shall express the service convention in the business halls and publicize the supervisory telephone numbers and Set up customer opinion book. 8403 The enterprise to customer criticism or complaints should be resolved in a timely manner, the quality of drugs reflected by customers, should be treated seriously, detailed records, and timely processing. 8404 Enterprises in the business store advertising should be in line with the relevant provisions of the state.