GSP certification inspection project for pharmaceutical wholesale enterprises (for Trial Implementation)
1. In order to unify the standards, standardize the GSP certification inspection of drugs and ensure the quality of certification work, the GSP certification inspection and evaluation standards for pharmaceutical wholesale enterprises are formulated according to the Quality Management Standard for Pharmaceutical Trading (2000. 1) and the Implementation Rules for the Quality Management Standard for Pharmaceutical Trading.
2. The GSP certification and inspection items of pharmaceutical wholesale enterprises are *** 132, including 37 key items (with "*" before the terms) and 95 general items.
3. During on-site inspection, the listed items and their contents shall be comprehensively inspected, and positive or negative evaluation shall be made item by item. All incomplete and incomplete projects are called defective projects; The unqualified key items are serious defects; Unqualified general items are general defects.
4, bureau certification center in the audit field report, such as the discovery of some general defects have a greater impact on the quality of drug business, then notify the enterprise to rectify within a time limit.
5. The sampling ratio of branches of pharmaceutical wholesale enterprises is 30%; Unqualified branches are considered as serious defects.
6. Evaluation of results:
Project results
Serious defect general defect
0 ≤ 10% passed GSP certification.
0 10-3 months 30% follow-up inspection after internal affairs reform.
≤2 ≤ 10%
≤ 2 > 10% failed GSP certification.
>2
0 >30%
GSP certification inspection project for pharmaceutical wholesale enterprises (for Trial Implementation)
Contents of clause inspection
* 040 1 An enterprise shall engage in pharmaceutical business activities in accordance with the business mode and business scope approved according to law.
050 1 An enterprise shall establish a quality leading organization headed by the principal responsible person, including the heads of business departments such as procurement, sales, storage and transportation, and the heads of enterprise quality management institutions.
The main responsibilities of the 0502 enterprise quality leading organization are: to establish the enterprise quality system, implement the enterprise quality policy, and ensure the enterprise quality management personnel to exercise their functions and powers.
* 060 1 The enterprise shall set up a special quality management organization with a quality management group and a quality acceptance group.
0602 The quality management organization of an enterprise should exercise the quality management function and have the right to make a ruling on the drug quality within the enterprise.
The enterprise quality management organization is responsible for drafting the drug quality management system of the enterprise, and guiding and supervising the implementation of the system.
0604 enterprise quality management organization is responsible for the quality audit of the first camp enterprises and the first camp varieties.
0605 The enterprise quality management organization is responsible for establishing the quality files of drugs handled by the enterprise, including quality standards and other contents.
* 0606 Enterprise quality management organization is responsible for the inquiry of drug quality and the investigation, handling and reporting of drug quality accidents or quality complaints.
0607 enterprise quality management organization is responsible for the acceptance of drugs.
0608 Enterprise quality management organization is responsible for guiding and supervising the quality work of drug storage, maintenance and transportation.
0609 enterprise quality management organization is responsible for the audit of unqualified drugs and supervision of the treatment process of unqualified drugs.
06 10 enterprise quality management organization is responsible for collecting and analyzing drug quality information.
06 1 1 The enterprise quality management institution shall assist in drug quality education or training for enterprise employees.
* 070 1 An enterprise shall set up inspection, maintenance and other organizations suitable for its business scale. Enterprise drug maintenance group or maintenance personnel shall accept the supervision and guidance of quality management institutions in their business.
0702 Large and medium-sized enterprises should set up drug maintenance teams. Small enterprises should set up drug maintenance teams or drug maintenance personnel.
* 080 1 The system formulated by the enterprise should include quality policy and target management, quality system audit, quality responsibility, quality rejection, quality information, audit of the first enterprise and the first variety, quality acceptance management, storage management, maintenance and outbound review management, relevant records and vouchers management, special drugs management, expired drugs, unqualified drugs and returned drugs management, quality accident management, quality inquiry and quality complaints.
* 0802 Enterprises shall regularly check and evaluate the implementation of the quality management system and keep records.
090 1 Enterprises should regularly conduct internal audit on the implementation of the Good Quality Management Practice for Pharmaceutical Trading.
100 1 The principal person in charge of an enterprise shall have professional titles and be familiar with the laws, regulations and rules of the state on drug management and the knowledge of drugs handled.
*110/person in charge of enterprise quality management. Large and medium-sized enterprises should have the technical titles of pharmacist in charge (including pharmacist in charge and pharmacist in traditional Chinese medicine) or engineer (including) in pharmacy-related majors (referring to medicine, biology and chemistry, the same below); Small enterprises should have the technical titles of pharmacists (including pharmacists and pharmacists of traditional Chinese medicine) or assistant engineers (including) or above.
* 120 1 The person in charge of the enterprise quality management institution should be a licensed pharmacist or meet the corresponding conditions of11.
1202 the person in charge of the enterprise quality management organization should be able to adhere to the principles and have practical experience, and can independently solve the quality problems in the operation process.
140 1 the personnel engaged in quality management in an enterprise should have the technical title of pharmacist (including pharmacist and pharmacist of traditional Chinese medicine) or above, or have a technical secondary school diploma in pharmacy or related majors.
1402 personnel engaged in quality management and inspection in enterprises shall undergo professional training and examination by provincial drug supervision departments and obtain post certificates before taking up their posts.
* 1403 the personnel engaged in quality management in enterprises should be on-the-job personnel, not part-time.
150 1 The personnel engaged in acceptance, maintenance, measurement and sales of an enterprise should have a high school education or above.
1502 the personnel engaged in acceptance, maintenance, measurement and sales of an enterprise shall pass the on-the-job training and the examination of the drug supervision and administration department at or above the prefecture level, and can only take up their posts after obtaining the post certificate.
1503 the personnel engaged in the positions stipulated by the national employment access must pass the professional skill appraisal and obtain the professional qualification certificate before taking up their posts.
* 1504 the full-time staff engaged in quality management, acceptance, maintenance and measurement of an enterprise shall be no less than 4% (at least 3) of the total number of employees and remain relatively stable.
160 1 Every year, the enterprise shall organize personnel who have direct contact with drugs, such as quality management, acceptance, maintenance and storage, to carry out health checks and establish health records.
1602 enterprises should immediately transfer patients suffering from mental illness, infectious diseases or other diseases that may contaminate drugs from their posts where they are in direct contact with drugs.
170 1 The enterprise shall regularly educate or train all kinds of personnel on drug laws, regulations, rules, professional skills, drug knowledge and professional ethics, and establish files.
1702 personnel engaged in quality management and inspection in enterprises shall receive continuing education organized by provincial drug supervision and administration departments every year; Personnel engaged in acceptance, maintenance and measurement should regularly receive continuing education organized by enterprises. The continuing education of the above-mentioned personnel should establish files.
180 1 An enterprise shall have its business premises, auxiliary and office buildings suitable for its business scale, and its business premises shall be bright and clean.
* 190 1 enterprises should set up corresponding warehouses according to their business scale, and their area (construction area, the same below) should be not less than 1500 square meters for large enterprises, 1000 square meters for medium-sized enterprises and 500 square meters for small enterprises.
1902 The reservoir area is flat, free of aquatic plants and pollution sources.
1903 the drug storage work area, auxiliary work area and office living area of an enterprise should be separated by a certain distance or have isolation measures, and the loading and unloading work place should be covered.
* 1904 the enterprise has warehouses suitable for classified storage of drugs and meeting the requirements of drug storage. Wherein the room temperature is 0-30 DEG C, the cold room temperature is not higher than 20 DEG C, and the cold storage temperature is 2-10 DEG C; The relative humidity of each warehouse should be kept between 45-75%.
1905 the walls, ceilings and floors in the warehouse are clean and flat, 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 drugs they operate. .
1906 there are fire control and safety facilities in the reservoir area that meet the specified requirements.
* 200 1 warehouse should be divided into special places such as warehouse to be inspected (area), qualified product warehouse (area), delivery warehouse (area), unqualified product warehouse (area), return warehouse (area), and special warehouse (area) should also be divided for operating Chinese herbal pieces. The above libraries (districts) should be clearly marked.
2 10 1 The warehouse shall be equipped with equipment to keep medicines at a certain distance from the ground.
2 102 The warehouse should be ventilated in the dark.
2 103 The warehouse should have equipment for detecting and adjusting temperature and humidity.
2 104 The warehouse should be equipped with dust-proof, moisture-proof, mildew-proof, pollution-proof, insect-proof, rat-proof, bird-proof and other equipment.
2 105 The warehouse should have lighting equipment that meets the requirements of safe electricity use.
2 106 The warehouse should have storage places and equipment suitable for unpacking, LCL delivery and packaging materials.
* 220 1 The special warehouse for enterprises to store specially managed drugs should have corresponding safety measures.
230 1 dealing in Chinese herbal medicines and Chinese herbal pieces should set up a Chinese herbal medicine specimen room (cabinet).
240 1 enterprises should set up acceptance and maintenance rooms in warehouses that are suitable for the scale of enterprises and meet the health requirements, and the area of large enterprises should not be less than 50 square meters; Medium-sized enterprises are not less than 40 square meters; Small enterprises are not less than 20 square meters.
2402 enterprise acceptance maintenance room should be equipped with11000 balance, purity detector and standard colorimetric solution; Enterprises dealing in Chinese herbal medicines and Chinese herbal pieces should also be equipped with moisture meters, ultraviolet fluorescent lamps, dissecting mirrors or microscopes.
2403 The acceptance and maintenance room of an enterprise shall be equipped with necessary moisture-proof and dust-proof facilities.
250 1 Enterprises shall regularly inspect, repair and maintain the facilities and equipment used, and establish files. 、
260 1 Enterprises should have special packaging places for Chinese herbal pieces, and the area and equipment should meet the packaging requirements.
The fixed sub-packaging room of 2602 enterprises for sub-packaging Chinese herbal pieces should be clean and tidy, and the walls and ceilings should not fall off.
270 1 Enterprises shall formulate procurement procedures to ensure that purchased drugs meet quality requirements.
* 2702 Enterprises should determine the legal qualifications and quality reputation of suppliers when purchasing goods. Drugs purchased by enterprises should be drugs produced or operated by legal enterprises.
* 2703 Enterprises should review the legality of drugs purchased when purchasing goods.
* 2704 Enterprises should verify the legal qualifications of the sales staff of suppliers who have business contacts with the enterprise when purchasing goods.
Enterprises should purchase goods according to the quality clause in the purchase contract.
280 1 the drugs purchased by enterprises shall have the legal approval number and production batch number, except those not stipulated by the state.
* 2802 Enterprises purchasing imported drugs should have copies of the Registration Certificate of Imported Drugs and the Inspection Report of Imported Drugs that meet the requirements and are stamped with the original seal of the supplier's quality inspection agency.
The packaging and labels of drugs purchased by enterprises shall conform to the relevant regulations and storage and transportation requirements.
Chinese herbal medicines purchased by enterprises should indicate the place of origin.
* 290 1 enterprises audit the first batch of enterprises, including qualification and quality assurance ability. By the business department in conjunction with the quality management institutions * * * audit. In addition to reviewing relevant information, field visits should be conducted when necessary. After examination and approval, goods can be purchased from the first enterprise.
* 300 1 The enterprise shall fill in the Approval Form for the First Pharmaceutical Operation for the first variety, which shall be reviewed and approved by the enterprise quality management organization and the competent leader of the enterprise. Basic information on the legality and quality of the first variety (including new specifications, new dosage forms, new packaging, etc.). ) should be reviewed, including verifying the approval number of drugs and obtaining quality standards, reviewing whether the packaging, labels and instructions of drugs meet the requirements, and understanding the performance, use, inspection methods, storage conditions and quality reputation of drugs. Only after passing the examination can the operation be carried out.
3 10 1 When making a procurement plan, an enterprise should take the quality of drugs as an important basis, with the participation of personnel from quality management institutions.
320 1 Enterprises should specify the quality terms when signing a purchase contract. The sales contract should be clear: the quality of the drug meets the quality standards and related quality requirements; The drug is accompanied by a product certificate; Drug packaging meets relevant regulations and cargo transportation requirements; When purchasing imported drugs, suppliers should provide certificates and documents that meet the requirements.
* 330 1 you must have legal bills to buy drugs, and establish purchase records according to regulations, so that tickets, accounts and goods are consistent. The purchase record shall indicate the name, dosage form, specification, expiration date, manufacturer, supplier, purchase quantity, purchase date and other contents of the drug. Procurement records shall be kept for more than 1 year, but not less than 3 years.
The procurement of specially managed drugs should be strictly in accordance with the relevant provisions of the state.
340 1 The enterprise shall conduct quality review on the procurement situation every year, and the review results shall be filed for future reference.
* 350 1 The enterprise shall check and accept the quality of drugs purchased and returned after sale in strict accordance with the legal standards and the quality clauses agreed in the contract, and make records.
At the time of acceptance, the packages, labels, instructions and relevant certificates or documents of drugs shall be inspected one by one. The label and attached instructions for drug packaging acceptance shall have the name and address of the manufacturer, including the name, specification, approval number, product batch number, production date and expiration date of the drug; The label or instructions shall also specify the ingredients, indications or functional indications, usage, dosage, contraindications, adverse reactions, precautions and storage conditions of the drug.
3503 The whole package acceptance should have the product certificate.
3504 For drugs under special management and drugs for external use, the labels or instructions on their packages have specified signs and warning instructions. Prescription drugs and over-the-counter drugs are classified according to the management requirements, and there are corresponding warning words or suggestions on the labels and instructions; The package of over-the-counter drugs has a special mark stipulated by the state.
When accepting imported drugs, the label of the package should indicate the name, main components and registration number of the drug in Chinese, and there should be Chinese instructions.
3506 A copy of the Registration Certificate of Imported Drugs and a qualified inspection report of imported drugs shall be provided for the acceptance of imported drugs; Imported preventive biological products and blood products should have a copy of the approval document for the import of biological products; Imported medicinal materials shall have a copy of the approval document for imported medicinal materials. The above approval documents shall be stamped with the original seal of the supplier's quality inspection agency or quality management agency.
3507 Acceptance of Chinese herbal medicines and Chinese herbal pieces shall be packaged and marked as qualified. On each package, Chinese herbal medicines are marked with names, places of origin and suppliers; Chinese herbal pieces shall be marked with the name, manufacturer and production date. Chinese herbal medicines and Chinese herbal pieces subject to document number management shall also be marked with the approval number on the packaging.
3508 acceptance samples should be representative.
* 3509 drug acceptance should be recorded. The acceptance record shall record the supplier, quantity, arrival date, product name, dosage form, specification, approval number, batch number, manufacturer, validity period, quality status, acceptance conclusion and acceptance personnel. Acceptance records shall be kept for more than 1 year, but not less than 3 years.
35 10 acceptance of the first variety should have the quality inspection report of the batch number of drugs.
35 1 1 Drugs returned after sale shall be inspected by the inspector according to the incoming goods inspection regulations, and sent to the inspection department for inspection if necessary.
* 35 12 narcotic drugs, psychotropic drugs of category I and toxic drugs for medical use shall be subject to the system of double acceptance.
The acceptance of 35 13 shall be carried out in a place that meets the requirements and completed within the specified time limit.
360 1 The warehouse keeper receives the goods, and the inspector signs or seals them. Have the right to reject the goods that are inconsistent with the bill, have abnormal quality, have weak or damaged packaging, and have vague labels, and report them to the relevant departments of the enterprise for handling.
370 1 Instruments, measuring instruments and titration solutions used for drug acceptance, inspection and maintenance shall have usage records and regular verification records.
400 1 Enterprises should control and manage unqualified drugs, and report unqualified drugs according to specified requirements and procedures.
* 4002 unqualified drugs should be stored in the unqualified drug warehouse (area) with obvious signs.
For unqualified drugs, it is necessary to find out the reasons for unqualified quality, distinguish the quality responsibility, deal with it in time and formulate preventive measures.
* 4004 There should be perfect procedures and records for the confirmation, reporting, loss reporting and destruction of unqualified drugs.
The disposal of 4005 unqualified drugs should be summarized and analyzed regularly.
* 4 10 1 drugs should be stored in the corresponding warehouse according to the requirements of temperature and humidity.
4 102 All drugs in stock should be managed by color code. Its unified standard is: the drug warehouse (area) to be tested and the drug warehouse (area) to be returned are yellow; Qualified drug warehouse (area), LTL weighing warehouse (area) and drug warehouse (area) to be sent are green; Unqualified drug warehouse (area) is red.
4 103 Handling and stacking should strictly comply with the requirements of graphic signs on drug packaging and standardize operations. The stacking height of drugs afraid of pressure should be controlled.
4 104 there should be corresponding spacing or isolation measures between the floor, wall, ceiling and radiator between the medicine and the warehouse. Drugs should be piled up at a certain distance. The distance between drugs and walls and roofs (beams) shall not be less than 30cm, the distance between drugs and radiators or heating pipes in warehouses shall not be less than 30cm, and the distance between drugs and the ground shall not be less than 10cm.
4 105 drugs should be piled up in a centralized way according to the batch number, and drugs with expiration date should be stored in a relatively centralized way, in order of batch number and expiration date or separately, and clearly marked.
4 106 For drugs approaching the expiration date, the expiration date report should be filled out every month.
* 4 107 drugs and non-drugs, drugs for internal use and drugs for external use should be stored separately; Drugs, Chinese herbal medicines, Chinese herbal pieces and easily smelled dangerous goods should be stored separately from other drugs.
* 4 108 narcotic drugs and toxic drugs for medical use should be stored in special warehouses or counters, kept by two people and double locks, with special account records and consistent accounts and goods.
* 4 109 Drugs returned after sale shall be collected with the return certificate issued by the management department and stored in the returned drug warehouse (area), which shall be kept by special personnel and recorded.
4 1 10 returned drugs can be put into the qualified drug warehouse (area) only after they are qualified, and the unqualified drugs can be put into the unqualified drug warehouse (area) only after they are recorded by the keeper.
4 1 1 1 The return record shall be kept for 3 years.
420 1 drug maintenance personnel should guide the custodians to store drugs reasonably.
* 4202 drug maintenance personnel should check the storage of drugs in the warehouse and cooperate with the storekeeper to monitor and manage the temperature and humidity of the warehouse. The temperature and humidity of the warehouse should be recorded regularly every morning and afternoon. If the temperature and humidity of the enterprise warehouse exceed the specified range, it shall take timely control measures and record them.
Drug maintenance personnel should adopt drying, oxygen reduction, fumigation and other methods. According to their characteristics.
4204 Drug maintenance personnel should regularly maintain and check the drugs in stock according to the circulation situation, and make records.
4205 Drug maintenance personnel shall promptly notify the quality management organization to review the problems found in the inspection.
4206 Drug maintenance personnel should regularly summarize, analyze and report quality information such as maintenance inspection, drugs that have recently taken effect or have been stored for a long time.
4207 drug maintenance personnel are responsible for the management of maintenance instruments and equipment, temperature and humidity monitoring instruments and measuring instruments in use in the warehouse.
4208 Drug maintenance personnel should establish drug maintenance files.
4209 If quality problems are found in inventory maintenance, obvious signs should be hung and delivery should be suspended, and the quality management organization should be informed to handle them.
430 1 The delivery of drugs should be "first in first out" and "first out in the near future", and delivered according to the batch number.
4302 Enterprises should stop drug delivery when they find the following problems, and report to relevant departments for handling:
1, abnormal sound and liquid leakage in drug packaging;
2. The outer package is damaged, the seal is not firm, the gasket is false, and the seal is seriously damaged.
3. The packaging mark is fuzzy or falls off;
This medicine has expired.
* 440 1 When drugs are delivered out of the warehouse, quality inspection and quantity and item check shall be conducted according to the delivery list. In order to facilitate quality tracking, the re-inspection record should include the purchasing unit, product name, dosage form, specification, batch number, validity period, manufacturer, quantity, sales date, quality status, re-inspection person and other items.
4402 narcotic drugs, psychotropic drugs of category I and toxic drugs for medical use should be checked by two people when leaving the warehouse.
The review record of 450 1 shall be kept for more than one year, but not less than three years.
460 1 Necessary heat preservation or cold storage measures should be taken according to seasonal temperature changes and transportation distance when transporting drugs with temperature requirements.
470 1 The transportation of specially managed drugs and dangerous goods shall be handled in accordance with relevant regulations.
* 480 1 When drugs are directly allocated by the production enterprise, they can only be delivered after the quality acceptance of the business unit.
490 1 handling, loading and unloading drugs should be handled with care, stacked in strict accordance with the requirements of graphic signs on the outer packaging, and protective measures should be taken.
When transporting drugs, corresponding measures should be taken according to the packaging situation and road conditions to prevent drugs from being damaged and confused.
* 500 1 Enterprises shall sell drugs to legally qualified units in accordance with relevant laws, regulations and rules.
5 10 1 Enterprises selling specially managed drugs shall strictly follow the relevant provisions of the state.
520 1 Sales personnel of enterprises shall introduce drugs correctly, and shall not falsely exaggerate or mislead users.
* 530 1 Enterprises selling drugs should issue legal bills to ensure that the tickets, accounts and goods are consistent. Sales bills should be kept as required.
* 5302 Enterprises shall establish drug sales records in accordance with regulations, recording the name, dosage form, expiration date, production enterprise, purchasing unit, sales quantity, sales date and other contents of drugs. Sales records shall be kept for more than one year, but not less than three years.
540 1 For drugs directly transferred from other businesses due to special needs, this enterprise shall ensure the quality of drugs and make relevant records in time.
550 1 Drug marketing publicity should strictly implement the national laws and regulations on advertising management, and the publicity content must be based on the instructions for drug use approved by the state drug supervision and administration department.
560 1 Find out the reasons for the quality problems found in the process of quality inquiry, complaint, spot check and sales, distinguish the responsibilities, take effective treatment measures and make records.
* 570 1 If any quality problems are found in the drugs sold by enterprises, they shall report to the relevant administrative departments, take back the drugs in time and make records.
5702 An enterprise shall, in accordance with the relevant national reporting system for adverse drug reactions and the relevant system of the enterprise, pay attention to collecting the adverse drug reactions sold by the enterprise and report them to the relevant departments as required.