Pharmaceutical wholesale enterprises GSP certification inspection program (for trial implementation)
1, in order to unify the standard, standardize the drug GSP certification inspection, to ensure the quality of certification work, according to the "Drug Certification Practice" 〈2000.7.1〉and the "Drug Certification Practice Implementing Rules", the development of pharmaceutical wholesale enterprises GSP certification inspection evaluation Standards.
2, pharmaceutical wholesale enterprises GSP certification inspection program **** 132 items, of which the key items (articles before the "*") 37, 95 general items.
3, on-site inspection, the items listed and its coverage of the contents of a comprehensive inspection, and make a positive or negative assessment of each item. All incomplete, incomplete items, known as defective items; key items failed for serious defects; general items failed for general defects.
4, the Bureau of Certification Center in the review of the site report, such as the general defects of the project that have a greater impact on the quality of drug business, then notify the enterprise to rectify the deadline.
5, pharmaceutical wholesalers branch sampling ratio of 30%; a branch failed, considered a serious defect.
6, the results of the assessment:
Items Results
Serious defects General defects
0 ≤10% through the GSP certification
0 10-30% within a period of 3 months to rectify the internal tracking inspection
≤2 ≤10%
≤2 ＞10% do not pass the GSP certification
>>>2<
0 ＞30%
GSP Certification Inspection Items for Pharmaceutical Wholesalers (for Trial Implementation)
Terms and Conditions Inspection Contents
* 0401 Enterprises shall engage in pharmaceutical business activities in accordance with the legally approved business methods and business scope.
0501 The enterprise shall establish a quality leadership organization headed by the main person in charge, including the person in charge of the business departments of purchase, sales, storage and transportation, and the person in charge of the enterprise's quality management organization.
0502 The main responsibilities of the enterprise quality leadership organization are: to establish the enterprise's quality system, to implement the enterprise quality policy, and to ensure that the enterprise quality management staff to exercise their authority.
* 0601 Enterprises should set up a special quality management organization, the organization set up under the quality management group, quality acceptance group.
0602 The quality management organization of the enterprise shall exercise the quality management function and have the right to adjudicate the quality of drugs within the enterprise.
0603 The enterprise quality management organization shall be responsible for drafting the enterprise's drug quality management system, and guiding and supervising 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 Enterprise quality management organization shall be responsible for the establishment of the enterprise's business drugs and including quality standards and other content of the quality file.
* 0606 Enterprise quality management organization shall be responsible for drug quality inquiries and drug quality accidents or quality complaints investigation, handling and reporting.
0607 The enterprise quality management organization shall be responsible for the acceptance of drugs.
0608 The enterprise quality management organization shall be responsible for guiding and supervising the quality of drug storage, maintenance and transportation.
0609 The enterprise quality management organization shall be responsible for the audit of the quality of unqualified drugs, and supervise the handling process of unqualified drugs.
0610 Enterprise quality management organization shall be responsible for collecting and analyzing drug quality information.
0611 The quality management organization of the enterprise shall assist in carrying out education or training on drug quality for the employees of the enterprise.
* 0701 The enterprise shall set up acceptance, maintenance and other organizations appropriate to the scale of operation. The enterprise drug maintenance group or caretaker in business should accept the supervision and guidance of the quality management organization.
0702 Large and medium-sized enterprises shall set up drug maintenance group. Small enterprises should establish a drug maintenance group or drug care workers.
* 0801 The system developed by the enterprise should include quality policy and target management, quality system audit, quality responsibility, quality veto, quality information, the first enterprise and the first variety of audit, quality acceptance management, storage storage, maintenance and out of the warehouse review management, the management of records and vouchers, the management of special medicines, expiration date of the management of medicines, unqualified medicines and returned medicines, quality accidents, quality inquiries and quality management.
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, education, training and assessment of quality, and so on.
* 0802 Enterprises should regularly check and assess the implementation of the quality management system and have records.
0901 Enterprises should regularly conduct internal review of the implementation of the "Good Manufacturing Practice in Drug Administration".
1001 The main person in charge of the enterprise shall have a professional and technical title, and be familiar with national laws, rules and regulations on drug management and knowledge of the drugs being operated.
* 1101 The person in charge of quality management of the enterprise, large and medium-sized enterprises should have a 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) above the technical title; small enterprises should have a pharmacist (including the pharmacist, pharmacist) or pharmacy-related professions, assistant engineer (including) above the technical title.
* 1201 The person in charge of the quality management organization of the enterprise should 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 principle, have practical experience, and can independently solve the quality problems in the operation process.
1401 The personnel engaged in quality management of the enterprise shall have the technical title of pharmacist (including pharmacist, Chinese pharmacist) or above, or have the education of secondary school (including) or above in pharmacy or related professions.
1402 Enterprises engaged in quality management and inspection of personnel should be qualified by the professional training and provincial drug supervision department exams, and obtain a certificate of post qualification before taking up their duties.
* 1403 Enterprises engaged in quality management personnel should be on duty, not part-time personnel.
1501 Enterprises engaged in acceptance, maintenance, measurement and sales personnel should have a high school (including) or higher education.
1502 Enterprises engaged in acceptance, maintenance, measurement and sales of personnel should be post training and drug supervision and management department at the municipal level (inclusive) or above to pass the examination, and obtain a certificate of qualification for the post before being allowed to work.
1503 Enterprises in the country have employment access provisions for personnel working in the post, the need to pass the vocational skills assessment and obtain a vocational qualification certificate before being allowed to take up their posts.
* 1504 Enterprises engaged in quality management, acceptance, maintenance and measurement of the number of full-time staff, should be not less than 4% of the total number of employees in the enterprise (the minimum should be not less than 3 people), and maintain relative stability.
1601 Enterprises should be organized annually in the quality management, acceptance, maintenance, custody and other direct contact with drugs and other personnel working in the position to carry out health checks, and establish health records.
1602 Enterprises found to suffer from mental illness, infectious diseases or other diseases that may contaminate the drug patients, should be immediately transferred out of direct contact with the drug positions.
1701 Enterprises should regularly carry out education or training on drug laws, regulations, rules and professional skills, drug knowledge, professional ethics and other education for all types of personnel, and establish files.
1702 Enterprises engaged in quality management, inspection of personnel, each year should be subject to the provincial drug supervision and management departments to organize continuing education; engaged in acceptance, maintenance, measurement and other personnel, should be regularly accepted by the enterprise organization of continuing education. Continuing education of the above personnel should establish a file.
1801 Enterprises should have with the scale of operation of the appropriate business premises and auxiliary, office space, business premises bright and clean.
* 1901 Enterprises should be set up according to the scale of operation of the appropriate warehouse, the area (for the building 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 pollution sources.
1903 Enterprises drug storage operation area, auxiliary operation area, office living area should be separated by a certain distance or have isolation measures, loading and unloading operations have a roof.
* 1904 Enterprises have suitable for drug classification and storage of drugs in line with the requirements of drug storage warehouse. Among them, the temperature of the room temperature library is 0-30 ℃, the temperature of the cool library is not higher than 20 ℃, the temperature of the cold storage is 2-lO ℃; the relative humidity of each warehouse should be maintained between 45-75%.
1905 The walls, ceiling and floor of the warehouse are clean and smooth, and the doors and windows are tightly structured. Enterprises should set up warehouses with different temperature and humidity conditions according to the storage requirements of the drugs they operate.
1906 The warehouse area has fire and safety facilities that meet the specified requirements.
* 2001 Warehouse should be divided into a warehouse to be examined library (area), qualified library (area), delivery library (area), non-conforming library (area), return library (area) and other specialized places, the operation of Chinese medicine should also be divided into a special library of zero cargo weighing (area). 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 facilities.
2103 The warehouse should have equipment to detect and regulate temperature and humidity.
2104 Warehouses should be dust-proof, moisture-proof, mold-proof, anti-pollution and insect-proof, rodent-proof, bird-proof equipment.
2105 Warehouses should be in line with the safety of electricity requirements of the lighting equipment.
2106 Warehouse should be suitable for the demolition of zero and consolidated shipment of places 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 operation of Chinese herbal medicines and Chinese herbal medicines should be set up specimen room (cabinet).
2401 Enterprises should be set up in the warehouse with the size of the enterprise, in line with the health requirements of the acceptance of the maintenance room, the area of large enterprises of not less than 50 square meters; medium-sized enterprises of not less than 40 square meters; small enterprises not less than 20 square meters.
2402 The acceptance of enterprises in the maintenance room should be equipped with one-thousandth of the balance, clarity detector, standard colorimetric liquid, etc.; enterprises operating Chinese herbal medicines, Chinese medicine tablets should also be equipped with moisture meter, ultraviolet fluorescent lamps, anatomical mirrors or microscopes.
2403 The acceptance of the enterprise maintenance room should have the necessary moisture, dust put ready.
2501 The facilities and equipment used by the enterprise should be regularly inspected, repaired, maintained and archived.
2601 Enterprises dispensing Chinese medicine tablets should be in accordance with the provisions of the special place, its area and equipment should be compatible with the requirements of the dispensing.
2602 The fixed dispensing room for enterprises to dispense Chinese medicine tablets shall have a clean environment and no shedding of walls and roof.
2701 Enterprises should establish an incoming procedure that can ensure that the purchased drugs meet the quality requirements.
* 2702 Enterprises should 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 should review the legality of the purchased drugs.
* 2704 Enterprises should purchase and the enterprise business contacts with the sales staff of the supply unit, to verify the legal qualifications.
2705 Enterprises should purchase goods in accordance with the quality terms of the purchase contract.
2801 The drugs purchased by the enterprise, except for those not stipulated by the state, should have the legal approval number and production lot number.
* 2802 Enterprises purchasing imported drugs should be in line with the provisions of the original seal stamped with the supplier's quality inspection agency, "Imported Drugs Registration Certificate" and "Imported Drugs Inspection Report" copy.
2803 Enterprises purchased drugs packaging and labeling should be in line with relevant regulations and storage and transportation requirements.
2804 Chinese herbal medicines purchased by enterprises should be labeled with the place of origin.
* 2901 The enterprise shall conduct an audit of the first enterprise, including qualifications and quality assurance capabilities. The audit shall be conducted by the business department in conjunction with the quality management organization***. In addition to reviewing the relevant information, if necessary, should be a site visit. Approved by the audit, only from the first business purchase.
* 3001 Enterprises to purchase the first varieties should fill out the "first business drug approval form", and by the 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 legitimacy and quality of the basic audit, including verification of the approval number of drugs and quality standards, audit of drug packaging, labeling, instructions, etc. Whether or not to comply with the provisions of the performance of the drug, the use of the test method, the storage conditions, as well as the quality of the reputation of the contents of the audit, and then only after the qualified business.
3101 Enterprises to prepare the purchase plan should be based on the quality of drugs as an important basis, and quality management organization personnel to participate.
3201 Enterprises to sign the purchase contract should be clear quality terms. The sales contract 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 cargo transportation requirements; purchase of imported drugs, the supply side should provide certificates and documents in line with the provisions.
* 3301 Purchase of drugs should have legal bills, and according to the provisions of the establishment of purchase records, to achieve the ticket, account, goods consistent. Purchase records should 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 saved to more than the expiration date of the drug 1 year, but not less than 3 years.
3302 Purchase of special management of drugs, should be in strict accordance with the relevant state management regulations.
3401 Enterprises should review the quality of the purchase of goods every year, and the results of the review are archived for inspection.
* 3501 Enterprises should strictly follow the legal standards and the quality terms of the contract on the quality of the purchased drugs, the sale of returned drugs for acceptance batch by batch, and have records.
3502 Acceptance should be accompanied by an individual inspection of the packaging, labeling, instructions, and relevant required certificates or documents of the drugs. 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 composition of the drug, indications or functions of the main body, usage, dosage, contraindications, adverse reactions, precautions, and storage conditions, and so on.
3503 Acceptance of the whole package should be product certification.
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 management, labeling, instructions have the appropriate warning or advice; non-prescription drugs have the packaging of the state's proprietary logo.
3505 Acceptance of imported drugs, 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 Chinese instructions.
3506 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 "imported biological products approval" copy; imported medicinal herbs should be "imported medicinal materials approval" copy. The above approval documents should be stamped with the original seal of the supplier's quality inspection agency or quality management organization.
3507 Acceptance of Chinese herbal medicines and Chinese medicinal herbs should be packaged with a sign of quality. On each package, Chinese herbal medicines marked with the name, origin, supply unit; Chinese medicine tablets marked with the name, manufacturer, production date. The implementation of the management of Chinese herbal medicines and Chinese medicine tablets, in the package should also be marked with the approval number.
3508 The samples taken for acceptance should be representative.
* 3509 Acceptance of drugs should be recorded. Acceptance inspection records should 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 more than 1 year beyond the expiration date, but not less than 3 years.
3510 Acceptance of the first varieties, there should be the batch number of the quality inspection report of the drug.
3511 For drugs returned after sale, the receiving and inspection personnel should be in accordance with the provisions of the purchase and acceptance of acceptance, if necessary, samples should be sent to the inspection department for inspection.
* 3512 For narcotic drugs, a class of psychotropic drugs, 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 completed within the specified time limit.
3601 The warehouse custodian receives the goods with the signature or seal of the inspector. The goods do not conform to the list, quality abnormalities, packaging is not secure or damaged, vague signs, etc., have the right to refuse to accept and report to the relevant departments of the enterprise to deal with.
3701 For drug acceptance, inspection, maintenance of instruments, measuring instruments and titrant, etc., should be used and regular calibration records.
4001 Enterprises should carry out controlled management of quality unqualified drugs, and the discovery of unqualified drugs should be reported in accordance with the specified requirements and procedures.
* 4002 Unqualified drugs should be stored in the unqualified drugs library (area), and have obvious signs.
4003 The unqualified drugs should identify the reasons for the unqualified quality, separate the quality responsibility, timely treatment and develop preventive measures.
* 4004 Unqualified drugs should be recognized, reported, reported loss, destruction should be perfect procedures and records.
4005 The handling of unqualified drugs should be summarized and analyzed on a regular basis.
* 4101 Drugs should be stored in the appropriate library according to 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) for the yellow; qualified drugs library (area), zero goods weighing library (area), to be sent to the drug library (area) for the green; unqualified drugs library (area) for the red.
4103 Handling and stacking should strictly comply with the requirements of the drug packaging symbols, standardized operation. Fear of pressure drugs should control the stacking height.
4104 There should be corresponding spacing or isolation measures between the drugs and the warehouse floor, wall, roof, radiator. The stacking of drugs should leave a certain distance. The distance between the drugs and the walls and roof (beams) is not less than 30 centimeters, the distance between them and the warehouse radiators or heating pipes is not less than 30 centimeters, and the distance between them and the floor is not less than 10 centimeters.
4105 The drugs should be stacked centrally according to the batch number, the validity period of the drugs should be classified relatively centralized storage, according to the batch number and the validity period of the near and far sequential or separate stacking and have a clear sign.
4106 For drugs with near expiration date, the expiration date statement should be filled out monthly.
* 4107 Drugs and non-drugs, internal drugs and external drugs, should be stored separately; drugs, Chinese herbal medicines, Chinese medicine and dangerous goods should be stored separately from other drugs.
* 4108 Narcotic drugs, toxic drugs for medical use should be stored in special libraries or special cabinets, double-locked storage, special account records, accounts and goods are consistent.
* 4109 The drugs returned after sale, with the return vouchers issued by the business sector to receive goods, stored in the return of drugs library (area), stored by a person and do a good job of return records.
4110 If the drugs returned after sale are accepted and qualified, they will be recorded by the custodian before being deposited in the qualified drugs library (area), and the unqualified drugs will be recorded by the custodian and placed in the unqualified drugs library (area).
4111 Return records should be kept for 3 years.
4201 The drug care personnel shall instruct the custodian to store the drugs in a reasonable manner.
* 4202 The drug care personnel shall check the storage conditions of the drugs in the warehouse, and cooperate with the custodian to monitor and manage the temperature and humidity of the warehouse. Every day, the temperature and humidity of the storage room should be recorded regularly in the morning and afternoon. Enterprise warehouse temperature, humidity exceeds the prescribed range, should be taken in a timely manner to control measures, and be recorded.
4203 Drug conservation personnel should be Chinese herbal medicines and Chinese medicine tablets according to their characteristics, take drying, oxygen reduction, fumigation and other methods of conservation.
4204 The drug care personnel shall carry out regular care and inspection of the stock of drugs according to the flow, and keep records.
4205 Drug care personnel should promptly notify the quality management organization to review and deal with the problems found in the inspection.
4206 Drug care personnel should regularly summarize, analyze and report the quality information of maintenance and inspection, near-expiry or long-stored drugs.
4207 Drug maintenance personnel shall be responsible for the maintenance of instruments and equipment, temperature and humidity detection and monitoring instruments, warehouse in use measuring instruments and apparatus management.
4208 Drug care personnel should establish drug care files.
4209 If quality problems are found in the inventory maintenance, the obvious sign and suspension of shipment should be hung and the quality management organization should be notified to deal with it.
4301 Drugs out of the warehouse should be "first produced first out", "recent first out" and according to the batch number delivery.
4302 Enterprises in the drug out of the warehouse, such as the following problems should be found to stop shipments, and reported to the relevant departments:
1, the drug package has an abnormal ringing and liquid leakage;
2, the outer packaging is broken, sealing is not secure, the liner is not solid, the seal is seriously damaged and other phenomena;
3, the packaging mark is blurred or off;
4, the drug has exceeded the expiration date of the package;
3, the packaging mark is blurred or off;
4, the drug has exceeded the expiration date of the package is not clear. p>4, the drug has exceeded the expiration date.
* 4401 When the review of drugs out of the warehouse, should be in accordance with the proof of delivery of the physical quality inspection and quantity, project verification. The review record made for quality tracking should include items such as purchasing unit, name, dosage form, specifications, lot number, expiration date, manufacturer, quantity, date of sale, quality status, and review personnel.
4402 Narcotic drugs, a class of psychotropic substances, toxic drugs for medical use should be double-checked when leaving the warehouse.
4501 Review records should be kept until more than one year beyond the expiration date of the drug, but not less than three years.
4601 The transportation of medicines with temperature requirements should take the necessary measures of heat preservation or refrigeration according to the seasonal temperature changes and transportation.
4701 The transportation of specially managed drugs and dangerous goods shall be handled in accordance with the relevant regulations.
* 4801 When the drugs are directly transferred from the production enterprises, they shall be shipped only after the quality inspection and acceptance by the operating units.
4901 Handling, loading and unloading of drugs should be carried gently and put down lightly, and stacked and protective measures should be taken in strict accordance with the requirements of the marking of the outer packaging illustration.
4902 When drugs are transported, appropriate measures should be taken to prevent damage and confusion of drugs according to the packing conditions and road conditions of the transported drugs.
* 5001 Enterprises shall sell medicines to legally qualified units in accordance with relevant laws, rules and regulations.
5101 Enterprises shall sell drugs under special management in strict accordance with relevant state regulations.
5201 Salespersons of the enterprise shall introduce the drugs correctly and shall not falsely exaggerate and mislead the users.
* 5301 Enterprises selling drugs should issue legal bills, so that bills, accounts and goods are consistent. Sales invoices should be kept in accordance with the regulations.
* 5302 Enterprises in accordance with the provisions of the establishment of drug sales records, record the name of the drug, dosage form, expiration date, manufacturer, purchasing unit, sales volume, sales date and other items. Sales records should be kept until more than one year beyond the expiration date of the drug, but not less than three years.
5401 For special needs from other commercial direct transfer of drugs, the enterprise should ensure the quality of drugs, and make timely records.
5501 The marketing and publicity of drugs should strictly implement the national laws and regulations on advertising management, and the content of the publicity must be based on the instructions for use of drugs approved by the State Drug Administration.
5601 The quality problems found in quality inquiries, complaints, sampling and sales process should be identified, responsibilities should be assigned, and effective measures should be taken to deal with them, and records should be kept.
* 5701 Enterprises have been sold drugs such as quality problems found, should be reported to the relevant management, and timely recovery of drugs and make records.
5702 Enterprises should pay attention to the collection of adverse reactions of the drugs sold by the enterprise in accordance with the provisions of the national system for reporting adverse drug reactions and the relevant systems of the enterprise, and should report to the relevant departments as required.