1, in order to unify the standards, standardize the drug GSP certification inspection, to ensure the quality of certification work, according to "Drug Certification Practice" (2000.7.1) and "Drug Certification Practice Implementing Rules", the development of pharmaceutical wholesale enterprises GSP certification inspection assessment standards.
2, pharmaceutical wholesale enterprises GSP certification inspection program **** 132 items, of which the key items (articles before the "*") 37 items, 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. All incomplete, incomplete items, known as defective items; key items failed for serious defects; general items failed for general defects.
4, drug wholesalers branch sampling ratio of 30%; a branch failed, as a serious defect.
5, the results of the assessment:
Items
Results
Serious defects
General defects
0
≤10%
Passed the GSP certification
0
10 to 30%
Delimited period of 3 months to rectify the tracking check
≤2
≤10%
≤2
>10%
No GSP certification
>2
0
≥30%
Pharmaceutical wholesalers "GSP certification on-site inspection program" (Trial)
Clause
Contents of Inspection
*0401
Enterprises shall engage in pharmaceutical business activities in accordance with the business methods and business scope approved by law.
0501
Enterprises 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 an enterprise's quality leadership organization are: to establish the enterprise's quality system, to implement the enterprise's quality policy, and to ensure that the enterprise's quality management staff exercise their authority.
*0601
Enterprises should set up a specialized quality management organization, and under the organization, there are quality management group and quality acceptance group.
0602
The quality management organization of the enterprise shall exercise the function of quality management, and shall have the right to adjudicate on the quality of drugs within the enterprise.
0603
The enterprise quality management organization shall be responsible for drafting the enterprise 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 operated drugs and including quality standards and other content of the quality file.
*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 drug quality accidents or quality complaints.
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 work in the storage, maintenance and transportation of drugs.
0609
The enterprise quality management organization shall be responsible for auditing the quality of unqualified drugs and supervising the process of handling unqualified drugs.
0610
The enterprise quality management organization shall be responsible for collecting and analyzing drug quality information.
0611
The enterprise quality management organization shall assist in carrying out education or training of enterprise employees in drug quality management.
*0701
Enterprises shall set up drug acceptance, maintenance and other organizations 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 maintenance group, and small enterprises shall set up a drug maintenance group or a drug maintenance clerk.
*0801
Enterprises should establish a system that includes quality policy and target management; quality system audit; quality responsibility; quality veto provisions; quality information management; first enterprise and first variety of the audit; quality acceptance management; warehousing, storage, maintenance and out of the warehouse review of the management; the management of the relevant records and vouchers; the management of the management of special management of medicines; expiration date of drugs, substandard drugs and returned drugs The management of special management drugs; expiration date drugs; management of substandard 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
The main person in charge of the enterprise shall have a professional and technical title and be familiar with the national laws, rules and regulations on drug management and the knowledge of the drugs being operated.
*1101
The person in charge of quality management of the enterprise, large and medium-sized enterprises shall have the technical title of pharmacist-in-charge (including pharmacist-in-charge, pharmacist-in-charge) or pharmacy-related professions (referring to the medical, biological, chemical and other professions, hereinafter the same) engineers (including) or more; small-scale enterprises shall have the technical title of pharmacist (including pharmacist-in-charge, pharmacist-in-charge) or pharmacy-related professions, assistant engineer (including) or more. The technical title.
*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 be able to independently solve the quality problems in the business process.
1401
Enterprises engaged in quality management personnel shall have a pharmacist (including pharmacist, Chinese pharmacist) or above technical title, or have a secondary school (including) or above the degree of pharmacy or related professions.
1402
Enterprises engaged in quality management personnel should be qualified by professional training and provincial drug supervision and management department exams, and obtain a certificate of post qualification before taking up their duties.
*1403
Enterprises engaged in quality management personnel 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 (or above) education.
1502
Enterprises engaged in the acceptance, maintenance, measurement and sales of personnel should be qualified by the post training and drug supervision and management department at the prefectural and municipal level (or above) examination, and obtain a certificate of qualification of the post before taking up their duties.
1503
Enterprises working in positions for which the state has employment access regulations shall be required to pass the vocational skills appraisal and obtain the vocational qualification certificate before being allowed to take up their posts.
*1504
The number of full-time staff of an enterprise engaged in quality management, acceptance, maintenance and measurement shall be not less than 4% of the total number of employees of the enterprise (the minimum number shall not be less than 3), and remain relatively stable.
1601
Enterprises should organize annual health checks for personnel working in quality management, drug acceptance, maintenance, storage and other positions with direct contact with medicines, and establish health records.
1602
Enterprises that find patients suffering from mental illness, infectious diseases or other diseases that may contaminate medicines should be immediately transferred out of positions with direct contact with medicines.
1701
Enterprises shall regularly educate or train all kinds of personnel on drug laws, regulations, rules and professional techniques, drug knowledge, professional ethics and other education, and establish files.
1702
Enterprises engaged in quality management personnel, each year should accept the provincial drug supervision and management department of the organization of 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 shall establish a file.
1801
Enterprises should have a business place and auxiliary, office space appropriate to 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 level, free of stagnant water and weeds, and free of pollution sources.
1903
Enterprises drug storage operation area, auxiliary operation area, office and living quarters should be separated by a certain distance or have isolation measures, and loading and unloading operations have a roof.
*1904
Enterprises have a warehouse that is suitable for the classification and storage of drugs and meets the requirements for drug storage. Among them, the temperature of the room temperature warehouse is 0 to 30 ℃, the temperature of the cool warehouse is not higher than 20 ℃, the temperature of the cold warehouse is 2 to 10 ℃; the relative humidity of each warehouse should be maintained between 45 to 75%.
1905
The walls, ceilings and floors in the warehouse are clean and smooth, and the doors and windows are tightly structured.
1906
The warehouse area has fire and safety facilities that meet the specified requirements.
*2001
The warehouse should be divided into a warehouse to be inspected (area), qualified goods warehouse (area), shipping warehouse (area), non-conforming goods warehouse (area), return warehouse (area) and other specialized places, the operation of Chinese medicine should also be divided into a special warehouse for the zero weighing (area). Above the library (area) 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
The warehouse should have equipment to detect and regulate temperature and humidity.
2104
Warehouses should have dust, moisture, mold, pollution and insect, rodent, bird and other equipment.
2105
Warehouses should be in line with the safe use of electricity requirements of the lighting equipment.
2106
Warehouses should have suitable workplaces and storage places and equipment for packaging materials, etc., which are suitable for the delivery of split and consolidated boxes.
*2201
Enterprises storing special management of drugs in a special warehouse should have the appropriate security measures.
2301
The business 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 is not less than 50 square meters; medium-sized enterprises is not less than 40 square meters; small enterprises is not less than 20 square meters.
2402
Enterprise acceptance of the maintenance room should be equipped with one-thousandth of the balance, clarity detector, standard colorimetric liquid; enterprises operating Chinese herbal medicines, traditional Chinese medicine tablets should be equipped with moisture meter, ultraviolet fluorescent lamps, anatomical mirrors or microscopes.
2403
Enterprise acceptance of the maintenance room should have the necessary moisture-proof, dust-proof equipment.
2501
Enterprises should regularly inspect, repair and maintain the facilities and equipment used and establish files.
2601
Enterprises dispensing traditional Chinese medicine tablets shall have a special place in accordance with the regulations, and its area and equipment shall be suitable for the dispensing requirements.
2602
The fixed dispensing room for enterprises to dispense Chinese medicinal tablets shall have a clean environment and no shedding of materials on the walls and ceilings.
2701
Enterprises shall establish an incoming procedure that can ensure that the purchased drugs meet the quality requirements.
*2702
Enterprises purchasing goods shall determine the legal qualifications and quality reputation of the supplying enterprises. Drugs purchased by enterprises shall be those produced or operated by legal enterprises.
*2703
Enterprises purchasing drugs shall examine the legality of the drugs purchased.
*2704
Enterprises purchasing goods shall verify the legal qualifications of the sales personnel of the supply units that have business contacts with the enterprise.
2705
Enterprises purchasing goods should be carried out in accordance with the quality clauses in the purchase contract.
2801
Enterprises purchasing drugs should have legal approval numbers and production lot numbers, except those not stipulated by the state.
*2802
Enterprises purchasing imported drugs should be in line with the provisions of the original seal stamped with the quality management organization of the supply unit of the "Certificate of Registration of Imported Drugs" and "Imported Drug Inspection Report" copy.
2803
Enterprises purchasing drugs packaging and labeling should be in line with relevant regulations and storage and transportation requirements.
2804
The Chinese herbal medicines purchased by the enterprises shall be labeled with the place of origin.
*2901
Enterprises shall conduct audits 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, field visits should be made. Approved by the audit, before buying from the first enterprise.
*3001
Enterprise purchases of 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. are in line with the provisions of the performance of the drug, use, storage conditions and quality reputation, etc., after passing the audit before operating.
3101
Enterprises should take the quality of drugs as an important basis for the preparation of the purchase plan, with the participation of personnel from quality management organizations.
3201
Enterprises signing purchase contracts should specify quality terms. Purchase and sales 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 provisions of the purchase, so that the tickets, accounts and goods are 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 kept for more than 1 year beyond the expiration date of the drug, but not less than 3 years.
3302
The purchase of special management of drugs should be carried out in strict accordance with the relevant state management regulations.
3401
Enterprises should conduct quality review of the purchase of goods every year, and the results of the review are archived for inspection.
*3501
Enterprises shall conduct batch-by-batch inspection and acceptance of the quality of purchased medicines and medicines returned after sale in strict accordance with the legal standards and the quality clauses stipulated in the contracts, and keep records.
3502
Acceptance should be accompanied by a case-by-case inspection of the packaging, labeling, and instructions of the medicines, as well as the relevant required certificates or documents. 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 product certification.
3504
Check and 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 over-the-counter drugs in accordance with the requirements of classification management, labeling, instructions have the appropriate warning or advice; over-the-counter drug packaging has the state's proprietary logo.
3505
Acceptance of imported medicines, the labeling of its packaging should be in Chinese indicating 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; imports of precautionary biological products, blood products, there should be "imported biological products approval" copy; imports of medicinal herbs there should be "imported medicinal herbs approval" copy. The above approval documents should be stamped with the original seal of the supplier's quality management organization.
3507
Acceptance of Chinese herbal medicines and Chinese herbal medicines should be packaged with the mark of quality. On each package, Chinese herbal medicines marked with the name, origin, supply unit; Chinese medicine tablets marked with the name, manufacturer, date of production. The implementation of the management of Chinese herbal medicines and Chinese medicinal herbs and Chinese medicinal tablets, in the package should also indicate the approval number.
3508
The samples taken for acceptance should be representative.
*3509
Acceptance inspection of drugs should be recorded. Acceptance inspection records should record the supply unit, quantity, date of arrival, name, dosage form, specifications, approval number, batch number, manufacturer, expiration date, quality status, acceptance conclusions and acceptance of personnel and other items. Acceptance inspection records should be kept until more than one year beyond the expiration date of the drug, but not less than three years.
3510
Acceptance acceptance of the first varieties, there should be the batch number of the quality inspection report of the drug.
3511
On the drugs returned after sale, the acceptance personnel shall accept them in accordance with the provisions of the incoming goods acceptance, and if necessary, shall take samples and send them to the inspection department for inspection.
*3512
For narcotic drugs, Class I psychotropic drugs, and toxic drugs for medical use, a two-person acceptance system shall be implemented.
3513
Acceptance inspection shall be carried out in a place that complies with the regulations, and be completed within the specified time limit.
3601
The warehouse custodian receives the goods with the signature or seal of the inspector. For the goods do not conform to the list, abnormal quality, packaging is not secure or broken, vague signs, etc., the right to refuse to accept and report to the relevant departments of the enterprise to deal with.
3701
Instruments and measuring instruments used for the acceptance and maintenance of medicines should be registered, used and regularly calibrated 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
Failed drugs should be stored in the unqualified drugs library (area), and have a clear sign.
4003
Failed drugs should be identified as the cause of unqualified quality, the responsibility for the quality of separation, timely treatment and develop preventive measures.
*4004
The confirmation, reporting, loss reporting and destruction of unqualified drugs should have perfect procedures or records.
4005
The handling of substandard drugs should be summarized and analyzed periodically.
*4101
Drugs should be stored in the appropriate library according to temperature and humidity requirements.
4102
All medicines in storage should be color-coded. 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 outer packaging of drugs, standardized operation. Fear of pressure medicines should be controlled stacking height.
4104
There should be appropriate spacing or isolation measures between the drugs and the warehouse floor, wall, roof, radiator. There should be a certain distance between the stacks of medicines. The spacing between medicines and walls and roofs (beams) should be not less than 30 centimeters, the spacing between medicines and warehouse radiators or heating pipes should be not less than 30 centimeters, and the spacing between medicines and the floor should be not less than 10 centimeters.
4105
Drugs should be stacked centrally according to batch number. Effective date of the drugs should be classified relatively centralized storage, according to the batch number and the validity of the near and far sequential or separate stacking and have a clear sign.
4106
Drugs with near expiration dates should be reported on a monthly basis.
*4107
Drugs and non-drugs, internal drugs and external drugs should be stored separately; drugs that are easy to cascade odor, Chinese herbal medicines, Chinese herbal medicines and dangerous goods should be stored separately from other drugs.
*4108
Narcotic drugs, a class of psychotropic substances, toxic drugs for medical use should be stored in a special warehouse or cabinet, double double-locked safekeeping, special account records, the account matches.
*4109
The medicines returned after sale shall be received with the return vouchers issued by the business department, stored in the returned medicine warehouse (area), and kept in the custody of a person who makes a good record of the returned medicines.
4110
Pharmaceuticals returned after sale are accepted and qualified, recorded by the custodian before being deposited in the qualified drugs library (area); unqualified drugs are recorded by the custodian and placed in the unqualified drugs library (area).
4111
Return records should be kept for 3 years.
4201
Drug caretakers shall instruct custodial staff on proper storage of drugs.
*4202
Drug caretakers shall check the storage conditions of drugs in storage and cooperate with custodians in monitoring and managing the temperature and humidity of the storage room. Daily should be on the morning and afternoon each time regularly on the warehouse temperature, humidity records. Enterprise warehouse temperature, humidity exceeds the prescribed range, should be taken in a timely manner to regulate measures, and be recorded.
4203
Pharmaceutical maintenance personnel should be Chinese herbal medicines and traditional Chinese medicine tablets according to their characteristics, take drying, oxygen reduction, fumigation and other methods of maintenance.
4204
Pharmaceutical care personnel shall regularly care for and inspect the stock of medicines according to their flow, and keep records.
4205
Pharmaceutical maintenance personnel shall promptly notify the quality management organization of the problems found during the inspection for review and treatment.
4206
Pharmaceutical care personnel shall periodically summarize, analyze and report quality information on care inspections, medicines with near expiration dates or those stored for long periods of time.
4207
Pharmaceutical maintenance personnel shall be responsible for the maintenance of instruments and equipment, temperature and humidity testing and monitoring instruments, measuring instruments and apparatus in use in the warehouse.
4208
Pharmaceutical maintenance personnel shall establish pharmaceutical maintenance files.
4209
If quality problems are found in the inventory maintenance, a clear sign and suspension of shipment shall be hung and the quality management organization shall be notified as soon as possible to deal with them.
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. abnormal ringing and liquid leakage in the drug package; 2. outer packaging is broken, sealing is not secure, the liner is not solid, and the seal is seriously damaged and other phenomena; 3. the packaging markings are ambiguous or detached; 4. the drug is beyond the expiration date.
*4401
Drugs out of the warehouse review, should be in accordance with the shipment voucher on the physical quality inspection and quantity, item verification. The review record made for quality tracking shall include items such as purchasing unit, name, dosage form, specifications, lot number, expiration date, manufacturer, quantity, date of sale, quality status and reviewer.
4402
Narcotic drugs, Class I psychotropic drugs, and toxic drugs for medical use shall be double-checked at the time of discharge.
4501
Records of review shall be kept until one year beyond the expiration date of the drug, but not less than three years.
4601
The transportation of medicines with temperature requirements shall 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 medicines are directly transferred from the manufacturing enterprises, they shall be shipped only after the quality inspection and acceptance of the operating units.
4901
Handling, loading and unloading of drugs should be carried 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 breakage and confusion of drugs in accordance with the packaging conditions of the transported drugs and road conditions.
*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
Enterprise salespersons shall correctly introduce medicines and shall not falsely exaggerate and mislead users.
*5301
Enterprises shall issue legal bills for the sale of medicines, so as to match the bills, accounts and goods. Sales invoices shall be kept in accordance with the regulations.
*5302
Enterprises shall establish drug sales records in accordance with the provisions of the drug name, dosage form, specifications, expiration date, manufacturer, purchasing unit, sales quantities, sales date and other items. Sales records should be kept until more than 1 year beyond the expiration date of drugs, but not less than 3 years.
5401
Drugs directly transferred from other commercial enterprises due to special needs, the enterprise shall ensure the quality of the drugs, and timely preparation of relevant records.
5501
Pharmaceutical marketing and publicity should strictly implement national laws and regulations on advertising management, and the content of the publicity must be based on the instructions for use of the drugs approved by the State Drug Administration.
5601
Quality inquiries, complaints, sampling and quality problems found in the course of sales should be identified, responsibilities should be assigned, effective measures should be taken to deal with them, and records should be kept.
*5701
Enterprises that have been sold drugs found to have quality problems should be reported to the relevant management, and timely recovery of drugs and make records.
5702
Enterprises shall pay attention to the collection of adverse reactions to medicines sold by the enterprise in accordance with the provisions of the national system for reporting adverse reactions to medicines and the enterprise's relevant system. Any adverse reaction situation found shall be reported to the relevant departments in accordance with the regulations.