Pharmaceutical wholesalers, "GSP certification on-site inspection program" (for trial implementation) terms of the inspection content *0401 enterprises should be in accordance with the business mode and business scope approved in accordance with the law, engaged in pharmaceutical business activities.0501 Enterprises should establish a quality leadership organization headed by the main person in charge, including the person in charge of the purchase, sales, storage and transportation and other business departments and the head of the enterprise's quality management organization.0502 The main responsibilities of the enterprise's quality leadership organization are: to establish the enterprise's quality system, the implementation of the enterprise's quality policy and to ensure that the enterprise's quality management staff to exercise their authority. *0601 The enterprise shall set up a specialized quality management organization, and the organization shall set up a quality management group and a quality acceptance group under the organization.0602 The enterprise quality management organization shall exercise the quality management function, and shall have the right to adjudicate the quality of medicines within the enterprise.0603 The enterprise quality management organization shall be responsible for drafting the enterprise's drug quality management system, and shall guide and supervise the implementation of the system.0604 The enterprise quality management organization shall be responsible for The quality audit of the first enterprise and the first variety.0605 The enterprise quality management organization shall be responsible for establishing the quality file of the drugs operated by the enterprise and including the quality standard and other contents. *0606 The quality management organization of the enterprise 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.0607 The quality management organization of the enterprise shall be responsible for the acceptance of the drugs.0608 The quality management organization of the enterprise shall be responsible for guiding and supervising the quality of the drugs in the storage, maintenance and transportation.0609 The quality management organization of the enterprise shall be responsible for the audit of the quality of the drugs which fail to meet the standards and shall supervise the treatment process of the drugs which fail to meet the standards. supervision of the handling process of unqualified drugs.0610 The enterprise quality management organization shall be responsible for collecting and analyzing information on drug quality.0611 The enterprise quality management organization shall assist in carrying out education or training on drug quality management for enterprise employees. *0701 The enterprise shall set up an organization for drug acceptance and maintenance that is appropriate to the scale of operation. The enterprise's drug conservation group or conservator shall be subject to the supervision and guidance of the quality management organization in its operations.0702 Large and medium-sized enterprises shall set up a drug conservation group, and small-sized enterprises shall set up a drug conservation group or a drug conservator. *0801 The system formulated by the enterprise shall include quality policy and target management; quality system audit; quality responsibility; quality veto provisions; quality information management; audit of the first enterprise and the first variety; quality acceptance management; management of storage and custody, maintenance and out-of-store review; management of relevant records and vouchers; management of special management drugs; management of expiration date drugs, unqualified drugs, and returned drugs management of quality accidents, quality inquiries and quality complaints; provisions for the reporting of adverse drug reactions; management of hygiene and health conditions of personnel; and provisions for quality-related education, training and assessment. *0802 Enterprises shall regularly check and assess the implementation of the quality management system, and have records.0901 Enterprises shall regularly conduct internal review of the implementation of the "Good Manufacturing Practice for Pharmaceuticals".1001 Enterprises shall have the main person in charge of the enterprise with a professional and technical title, and be familiar with the state's laws, rules and regulations on the management of pharmaceuticals and knowledge of the pharmaceuticals they are operating. *1101 enterprise quality management work of the person in charge, large and medium-sized enterprises should have the pharmacist in charge (including the pharmacist in charge, the pharmacist in charge of Chinese medicine) or pharmacy-related professions (refers to medicine, biology, chemistry and other professions, the same below) engineer (including) or more technical titles; small enterprises should have the pharmacist (including the pharmacist, Chinese pharmacist) or pharmacy-related professions of assistant engineers (including) or more technical titles. *1201 The person in charge of the quality management organization of the enterprise shall be a licensed pharmacist or meet the corresponding conditions of item 1101.1202 The person in charge of the quality management organization of the enterprise shall be able to adhere to the principles, have practical experience, and can independently solve the quality problems in the business process.1401 The personnel engaged in quality management work of the enterprise shall have the technical title of pharmacist (including pharmacist, Chinese pharmacist) or above, or have the secondary school (including) or above in pharmacy or related majors.1402 The personnel engaged in quality management work in the enterprise shall be qualified by professional training and examination of provincial drug supervision and management department, and obtain the post qualification certificate before they are allowed to take up the post. *1403 Enterprises engaged in quality management work shall be on duty and shall not be part-time personnel.1501 Enterprises engaged in acceptance, maintenance, measurement and sales work shall have a high school (including) or higher education.1502 Enterprises engaged in acceptance, maintenance, measurement and sales work shall be qualified by the post training and the examination of drug supervision and management departments at the prefecture and municipal level (or above), and shall be allowed to take up the post only after obtaining a certificate of qualification for the post. Certificate of Competence before taking up the post.1503 Enterprises in the country have employment access provisions of the position of the personnel working, need to pass the vocational skills appraisal and obtain vocational qualification certificates before taking up the post. *1504 The number of full-time personnel engaged in quality management, acceptance, maintenance and measurement should be not less than 4% of the total number of employees in the enterprise (the minimum should not be less than 3), and remain relatively stable.1601 Enterprises should annually organize the health examination of personnel working in the positions of quality management, acceptance of medicines, maintenance and storage that are in direct contact with the medicines, and set up health files.1602 Enterprises found to be Suffering from mental illness, infectious diseases or other diseases that may contaminate drugs, patients should be immediately transferred out of direct contact with drugs.1701 Enterprises should regularly carry out education or training for all kinds of personnel on drug laws, regulations, rules and professional techniques, drug knowledge, professional ethics, etc., and set up a file.1702 Enterprises engaged in quality management personnel should be subjected to continuing education organized by the provincial drug supervision and management department every year. education; personnel engaged in acceptance, maintenance, measurement, etc., shall regularly receive continuing education organized by the enterprise. The continuing education of the above personnel shall establish a file.1801 Enterprises should have a business place and auxiliary and office rooms that are compatible with the scale of operation. The business premises are bright and clean. *1901 Enterprises should be set up according to the scale of operation of the appropriate warehouse, its area (for the floor area, the same below) large enterprises should not be less than 1500 square meters, medium-sized enterprises should not be less than 1000 square meters, small enterprises should not be less than 500 square meters.1902 The ground in the warehouse area is smooth, no water and weeds, no source of contamination.1903 Enterprises, drug storage operations, auxiliary operating areas, office and living areas should be separated by a certain distance or have isolation measures, loading and unloading operations have a roof. *1904 Enterprises have a warehouse that is suitable for drug classification and storage and meets the requirements for drug storage. The temperature of the room temperature warehouse for 0 ~ 30 ℃, the temperature of the cool warehouse is not higher than 20 ℃, the temperature of the cold warehouse for 2 ~ 10 ℃; the relative humidity of the warehouse should be maintained between 45 ~ 75%.1905 warehouse walls, roofs and floors are clean and smooth, doors and windows of the structure is tight.1906 warehouse area in line with the provisions of the requirements of the fire, safety facilities. *2001 warehouse should be divided into a warehouse to be inspected (area), qualified goods warehouse (area), shipping warehouse (area), non-qualified goods warehouse (area), return warehouse (area) and other specialized places, the operation of Chinese medicine should also be divided into a special warehouse (area) for the zero weighing of Chinese medicine. The above libraries (districts) should be equipped with obvious signs.2101 Warehouses should maintain a certain distance between the drugs and the ground equipment.2102 Warehouses should be light, ventilation equipment.2103 Warehouses should be detected and regulate the temperature and humidity equipment.2104 Warehouses should be dust-proof, moisture-proof, mildew-proof, anti-pollution and pest control, rodent-proof, anti-bird, etc. 2105 Warehouses should be in line with the requirements of safe electricity lighting equipment.2106 Warehouses should meet the safety requirements of electricity. Lighting equipment. 2106 warehouse should be suitable for the demolition of zero and consolidated shipment of workplaces and packaging materials and other storage places and equipment. *2201 enterprises to store special management of drugs in the special warehouse should have the appropriate safety measures.2301 Chinese herbal medicine and Chinese medicine tablets should be set up in the specimen room (cabinet).2401 enterprises should be set up in the warehouse with the size of the enterprise, in line with the hygiene requirements of the acceptance of the maintenance room, the area of large-scale enterprises of not less than 50 square meters; medium-sized enterprises of not less than 40 square meters; small-scale enterprises of not less than 20 square meters. 20 square meters.2402 acceptance of enterprises should be equipped with one-thousandth of the maintenance room balance, clarity detector, standard colorimetric solution, etc.; enterprises operating Chinese herbal medicines, Chinese medicine tablets should also be equipped with moisture meter, ultraviolet fluorescent lamps, dissecting mirrors or microscopes. The acceptance and maintenance room of the enterprise shall have necessary moisture-proof and dust-proof equipments.2403 The facilities and equipments used by the enterprise shall be regularly inspected, repaired, maintained and archives shall be set up.2601 The enterprise shall have a special place in conformity with the regulations for the dispensing of traditional Chinese medicinal herbs and tablets, and the area and equipments shall be compatible with the requirements for the dispensing of such herbs and tablets.2602 The fixed dispensing room of the enterprise for the dispensing of traditional Chinese medicinal herbs and tablets shall have a neat and tidy environment, and the walls and ceiling shall be free of shedding materials.2701 Enterprises shall formulate incoming goods procedures that can ensure that the purchased drugs meet the quality requirements. *2702 Enterprises shall determine the legal qualifications and quality reputation of the supplier enterprises. The drugs purchased by the enterprise shall be those produced or operated by legal enterprises. *2703 Enterprises purchasing goods shall review the legality of the purchased drugs. *2704 Enterprises should be purchased with the enterprise business contacts with the supplier unit sales staff, the legal qualifications of the verification.2705 Enterprises should be purchased in accordance with the quality provisions of the purchase contract.2801 Enterprises purchased drugs in addition to the state does not provide for the exception, there should be a legal approval number and production lot number. *2802 Enterprises purchasing imported drugs should comply with the regulations, stamped with the original seal of the quality management organization of the supply unit of the "Certificate of Registration of Imported Drugs" and "Imported Drugs Inspection Report" copy.2803 Enterprises purchasing drugs should be in accordance with the relevant provisions of the packaging and labeling and storage and transportation requirements.2804 Enterprises purchasing Chinese herbal medicines should be labeled with the place of origin. *2901 The enterprise shall conduct an audit of the first enterprise including the qualification and quality assurance capability. The audit shall be conducted by the business department in conjunction with the quality management organization***. In addition to reviewing the relevant information, a site visit shall be made if necessary. After the audit and approval, the goods can be imported from the first enterprise. * 3001 enterprises to purchase the first species should fill out the "first business drug approval form", and by the enterprise quality management organization and the competent leadership of the enterprise audit approval. The first varieties (including new specifications, new dosage forms, new packaging, etc.) should be the legality and quality of the basic situation of the audit, including verification of the approval number of drugs and quality standards, audit of drug packaging, labeling, instructions, etc. is in line with the provisions of the performance of the drug, use, storage conditions and quality reputation, etc., after passing the audit before the business. 3101 enterprises to prepare the purchase of goods plan should be based on the quality of drugs as an important basis, and have the competent leadership of the enterprise review and approval. quality as an important basis, with the participation of personnel from the quality management organization.3201 Enterprises signing purchase contracts should specify quality terms. Purchase and sale contracts should be clear: the quality of drugs in line with quality standards and relevant quality requirements; drugs with product certification; drug packaging in line with relevant regulations and requirements for the transportation of goods; the purchase of imported drugs, the supply side should provide certificates and documents in line with the provisions of the regulations. *3301 Purchase of drugs should have legal bills, and purchase records should be established in accordance with the regulations, so as to ensure that the bills, accounts and goods are in line with each other. Purchase records shall indicate the name of the drug, dosage form, specifications, expiration date, manufacturer, supplier, quantity purchased, date of purchase and other items. Purchase records should be kept for more than 1 year beyond the expiration date of the drug, but not less than 3 years. 3302 Purchase of special management of drugs, should be in strict accordance with the relevant provisions of the state management.3401 Enterprises should be imported annually for quality review, the results of the review archived for inspection. *3501 Enterprises shall conduct batch-by-batch acceptance of the quality of purchased medicines and medicines returned after sale in strict accordance with the legal standards and the quality terms stipulated in the contract, and keep records.3502 Acceptance shall be accompanied by a batch-by-batch inspection of the packaging, labeling, and instruction manuals of the medicines, as well as of the certificates or documents of the relevant requirements. Acceptance of drug packaging labels and accompanying instructions should be the name and address of the manufacturer, the name of the drug, specifications, approval number, product batch number, date of production, expiration date, etc.; labels or instructions should also be the ingredients of the drug, indications or functions of the main body, usage, dosage, contraindications, adverse reactions, precautions, and storage conditions, etc..3503 Acceptance of the whole package should be the certificate of conformity of the product. 3504 acceptance of special management of drugs, drugs for external use, the labeling or instructions on the package has the required identification and warning instructions. Prescription drugs and non-prescription drugs in accordance with the requirements of classification and management, labels, instructions have the appropriate warning or advice; non-prescription drug packaging has the national provisions of the proprietary logo.3505 Acceptance of imported medicines, the labeling of its packaging should be in Chinese to indicate the name of the drug, the main ingredients, and the registration certificate number, and there are instructions in Chinese.3506 Acceptance of imported medicines, there should be in line with the requirements of the "Certificate of Registration of Imported Drugs" and "the Imported Drug Inspection Report" copy; imported precautionary biological products, blood products should be "biological products import approval" copy; imported medicinal materials should be "imported medicinal materials approval" copy. The above approval documents should be stamped with the original seal of the quality management organization of the supplying unit.3507 Acceptance of Chinese herbal medicines and Chinese herbal medicines should be packaged with the mark of quality. On each package, the Chinese herbal medicines are labeled with the name, place of origin, supply unit; Chinese medicine tablets are labeled with the name, manufacturer, date of production. Implementation of document number management of Chinese herbal medicines and Chinese medicine tablets, in the package should also be marked with the approval number.3508 Acceptance inspection of samples taken should be representative. *3509 Acceptance inspection of drugs should be recorded. Acceptance inspection records shall record the supply unit, quantity, date of arrival, product name, dosage form, specifications, approval number, batch number, manufacturer, expiration date, quality status, acceptance conclusions and acceptance of personnel and other items. Acceptance records should be kept until the expiration date of the drug is more than one year, but not less than three years.3510 Acceptance of the first varieties, there should be the batch number of the quality inspection report of the drug.3511 On the sale of drugs returned after the receipt, the acceptance personnel should be in accordance with the provisions of the incoming acceptance of the acceptance of the goods, and, if necessary, should be sent to the inspection department of the sample test. *3512 For narcotic drugs, Class I psychotropic drugs, and toxic drugs for medical use, a two-person acceptance system should be implemented.3513 Acceptance should be carried out in a place that complies with the regulations, and be completed within the stipulated time limit.3601 Warehouse custodians receive the goods with the signatures or seals of the acceptance officers. In case of discrepancy between the goods and the bill, abnormal quality, poor or damaged packaging, blurred marking, etc., they shall have the right to refuse acceptance and report to the relevant departments of the enterprise for handling.3701 Instruments and measuring instruments used for the acceptance and maintenance of medicines shall have the records of registration, use and periodic calibration.4001 Enterprises shall carry out controlling management of medicines of unqualified quality, and the discovery of unqualified medicines shall be reported to the relevant departments of the enterprise in accordance with the stipulated requirements and procedures. *4002 Unqualified drugs should be stored in the unqualified drugs library (area), and have a clear sign.4003 Unqualified drugs should be identified as the cause of unqualified quality, to separate the quality responsibility, timely treatment and develop preventive measures. *4004 The confirmation, reporting, reporting loss, destruction of substandard medicines should have perfect procedures or records.4005 The handling of substandard medicines should be summarized and analyzed on a regular basis. *4101 Drugs should be stored in the appropriate library according to the temperature and humidity requirements.4102 All drugs in storage should be color-coded management. The unified standard is: pending inspection of the drug library (area), the return of drugs library (area) is yellow; qualified drug library (area), zero goods weighing library (area), to be sent to the drug library (area) is green; unqualified drugs library (area) is red.4103 Handling and stacking should be in strict accordance with the requirements of the drug packaging graphic symbols, standardized operation. The stacking height of the drugs should be controlled for fear of pressure.4104 There should be corresponding spacing or isolation measures between the drugs and the floor, wall, roof and radiator of the warehouse. There should be a certain distance between the stacks of medicines. The distance between medicines and walls and roofs (beams) should be not less than 30 centimeters, the distance between medicines and warehouse radiators or heating pipes should be not less than 30 centimeters, and the distance between medicines and the floor should be not less than 10 centimeters.4105 Medicines should be centrally stacked according to batch number. Medicines with expiration dates should be categorized and stored in a relatively centralized manner, and stacked sequentially or separately according to the lot number and expiration date with obvious signs.4106 For medicines with near expiration dates, expiration date statements should be filled out on a monthly basis. *4107 Drugs and non-drugs, internal drugs and external drugs should be stored separately; drugs that are easy to cascade flavors, Chinese herbal medicines, Chinese herbal medicines and dangerous goods should be stored separately from other drugs. *4108 Narcotic drugs, a class of psychotropic drugs, toxic drugs for medical use should be stored in special libraries or special cabinets, double double-locked storage, special account records, the account matches. *4109 For drugs returned after sale, with the return voucher issued by the operating department to receive goods, stored in the return of drugs library (area), by the person in charge of custody and make a good record of the return of goods.4110 After the sale of drugs returned after acceptance of the qualified, by the custodian of the record can only be deposited into the qualified drugs library (area); unqualified drugs by the custodian of the record into the unqualified drugs library (area).4111 The return of goods record should be kept for for 3 years.4201 Drug care personnel shall instruct custodial staff on proper storage of drugs. *4202 Drug care personnel shall check the storage conditions of the drugs in storage and cooperate with the custodian to monitor and manage the temperature and humidity of the storage room. The temperature and humidity of the warehouse should be recorded regularly once a day in the morning and once in the afternoon. If the temperature and humidity of the storage room of an enterprise exceeds the prescribed range, it shall promptly take regulatory measures and record them.4203 The drug conservation personnel shall take care of the Chinese herbal medicines and Chinese herbal medicinal tablets according to their characteristics by methods such as drying, oxygen reduction, and fumigation.4204 The drug conservation personnel shall carry out regular conservation and inspection of the stock of medicines according to their flow and record them.4205 The drug conservation personnel shall, in respect of the problems found in the inspection promptly notify the quality management organization to review and deal with the problem.4206 The drug conservation personnel shall regularly summarize, analyze and report the quality information such as conservation and inspection, drugs with near expiration date or stored for a long period of time.4207 The drug conservation personnel shall be responsible for the management of instruments and equipment used for conservation, temperature and humidity detecting and monitoring instruments, and measuring instruments and appliances in use in the warehouses, etc.4208 The drug conservation personnel shall establish the drug conservation files.4209 If any problem is found during the inventory conservation, it shall be reported to the quality management organization in a timely manner. 4209 Inventory maintenance, if quality problems are found, should hang a clear sign and suspension of shipments, and as soon as possible to notify the quality management organization to deal with.4301 Drugs out of the warehouse should be "first produced first out", "recent first out" and according to the batch number of shipments.4302 Enterprises in the If the following problems are found when the drugs are shipped out of the warehouse, the shipment should be stopped and reported to the relevant departments for processing: 1. abnormal rattling and liquid leakage in the drug package; 2. the outer package is damaged, the seal is not secure, the liner is not solid, and the seal is seriously damaged, etc.; 3. the package marking is ambiguous or detached; and 4. the drugs are out of the expiration date. *4401 drugs out of the warehouse review, should be in accordance with the delivery voucher on the physical quality inspection and quantity, project verification. The review record made to facilitate quality tracking shall include items such as purchasing unit, product name, dosage form, specifications, batch number, expiration date, manufacturer, quantity, date of sale, quality status and reviewing personnel.4402 Narcotic drugs, Class I psychotropic drugs, and toxic drugs for medical use shall be double-checked at the time of their release from the warehouse.4501 The record of the review shall be kept for up to one year beyond the expiration date of the drugs, but not less than three years. 4601 For the transportation of drugs with temperature requirements, necessary measures of heat preservation or refrigeration shall be taken according to the seasonal temperature changes and the shipment.4701 The transportation of specially managed drugs and dangerous goods shall be handled in accordance with the relevant provisions.4801 The transportation of drugs shall be handled in accordance with the relevant provisions. *4801 When the drugs are directly transferred from the manufacturing enterprises, they shall be shipped only after the quality inspection and acceptance by the operating units.4901 The handling, loading and unloading of the drugs shall be carried gently and put down gently, and the drugs shall be piled up and protective measures shall be taken strictly in accordance with the requirements of the marking of the outer package illustrations.4902 When the drugs are transported, corresponding measures shall be taken for the packaging conditions of the drugs to be transported as well as for the road conditions, so as to prevent the drugs from being broken and mixed up. *5001 Enterprises shall sell medicines to legally qualified units in accordance with relevant laws, rules and regulations.5101 Enterprises shall sell specially managed medicines in strict accordance with relevant state regulations.5201 Salespersons of enterprises shall introduce medicines correctly, and shall not falsely exaggerate and mislead the users.5301 Enterprises shall sell medicines in accordance with relevant state regulations.5301 Enterprises shall sell medicines in accordance with relevant state regulations. *5301 Enterprises selling medicines shall issue legal bills, so as to match the bills, accounts and goods. Sales invoices shall be kept in accordance with regulations. *5302 Enterprises shall establish sales records of medicines in accordance with the regulations, recording the name, dosage form, specifications, expiry date, manufacturer, purchasing unit, sales quantity, sales date and other items of medicines. The sales records shall be kept for one year beyond the expiration date of the drugs, but not less than three years.5401 For the drugs directly transferred from other commercial enterprises due to special needs, the enterprise shall ensure the quality of the drugs and make the relevant records in time.5501 The marketing and publicity of the drugs shall be in strict accordance with the laws and regulations of the state regarding the management of advertisements, and the content of the publicity shall be based on the instruction manuals of the drugs approved by the State Drug Administration and Supervision Department. 5601 Quality inquiries, complaints, sampling and quality problems found during the sales process shall be identified, responsibilities assigned, effective treatment measures taken, and records made. *5701 If quality problems are found in medicines that have been sold by an enterprise, the enterprise shall report them to the relevant management department and recover the medicines in time and keep records.5702 Enterprises shall pay attention to the collection of adverse reactions of medicines sold by the enterprise in accordance with the provisions of the state's system for reporting adverse reactions to medicines and the relevant system of the enterprise. The discovery of adverse reactions should be reported to the relevant departments in accordance with the regulations.