(1), warehouse and environmental requirements
1. Enterprises should have warehouses suitable for their business scale. Its area (building area) shall meet the following requirements: large enterprises shall not be less than 1500M2, medium-sized enterprises shall not be less than 1000M2 and small enterprises shall not be less than 500M2.
2. Requirements for the environment in the reservoir area: The ground in the reservoir area should be flat, free from stagnant water and weeds, and free from pollution sources.
3. The warehouse shall meet the following requirements; Safety requirements for site selection and reservoir area;
1) site selection requirements: the drug storage work area, auxiliary work area and office living area should be separated by a certain distance or have isolation measures, and the loading and unloading work area should have a roof.
2) Warehouse construction requirements: The warehouse has warehouses suitable for classified storage of drugs and meeting the requirements of drug storage. The walls, ceilings and floors in the warehouse are smooth and flat, and the doors and windows are tightly structured.
3) Fire safety requirements: The reservoir area should have fire safety measures that meet the specified requirements.
4. The warehouse has a reasonable functional partition. The warehouse should be divided into special places such as the warehouse to be inspected (area), the qualified product warehouse (area), the delivery warehouse (area), the unqualified product warehouse (area), the return warehouse (area), and the special warehouse (area) for operating Chinese herbal pieces should also be divided. Each reservoir area should set up obvious signs.
Note: The above-mentioned large-scale pharmaceutical wholesale and retail chain enterprises refer to enterprises with annual pharmaceutical sales of more than 200 million yuan; Medium-sized enterprises refer to enterprises with annual drug sales between 50 million yuan and 200 million yuan; Small enterprises refer to enterprises with annual drug sales below 50 million yuan;
(2), warehouse facilities and equipment requirements
1, the equipment keeps the medicine at a certain distance from the ground;
2. Lighting, ventilation and drainage equipment;
3. Equipment for detecting and adjusting temperature and humidity;
4. Dust-proof, moisture-proof, mildew-proof, pollution-proof, insect-proof, rat-proof, bird-proof and other equipment;
5. Lighting equipment that meets the requirements of safe electricity use;
6. Workplaces suitable for unpacking and LCL, and places and equipment for delivery and storage of packaging materials.
7 pharmaceutical wholesale and retail enterprises shall set up warehouses with different temperature and humidity conditions according to the storage requirements of the drugs they operate. The temperature of cold storage should reach 2 ~ 65438 00℃; The temperature of cold storage shall not exceed 20℃; The room temperature is 0-30 DEG C; The relative humidity of each warehouse should be kept between 45~75%.
8, narcotic drugs, psychotropic drugs, toxic drugs for medical use, radioactive drugs storage should have a special warehouse and corresponding safety measures.
(3) Facilities, equipment and requirements of the business premises
1, drug retail enterprises should have business premises and drug warehouses suitable for the scale of operation, clean environment, no pollutants, and equipped with equipment to adjust temperature and humidity. The business premises, warehouses, office life and other areas of an enterprise shall be separated.
2 drug retail business premises and warehouse area requirements:
① Business area of large retail enterprises 100M2, warehouse 30M2；;
② The business area of medium-sized retail enterprises is 50M2, and the warehouse is 20M2；;
(3) Small retail enterprises have business premises of 40M2 and warehouses of 20M2；;
④ The business area of retail chain stores is 40M2.
3, drug retail establishments and drug warehouses should be equipped with equipment:
①
The business premises of pharmaceutical retail enterprises and retail chain stores should be spacious and tidy, with complete shelves and counters for business and eye-catching signs on the sales cabinets;
②
Drug retail enterprises and retail chain stores shall be equipped with complete weighing instruments, clean and hygienic drug dispensing tools and packaging supplies, and equipped with refrigeration equipment according to needs to preserve everything at low temperature;
③
Retail enterprises and retail chain stores selling specially managed drugs shall be equipped with counters and storage equipment and tools for storing specially managed drugs;
④ Necessary equipment for drug inspection, acceptance and maintenance;
⑤ Equipment for testing and adjusting temperature and humidity;
⑥ Equipment for keeping drugs at a certain distance from the ground;
⑦ Dust-proof, moisture-proof, pollution-proof, insect-proof, rat-proof, mildew-proof and other equipment;
Formula and processing equipment of Chinese herbal pieces;
4. A pharmaceutical retail chain enterprise shall set up a distribution center suitable for its business scale, and its storage, acceptance, inspection, maintenance and other facilities are the same as those of a wholesale enterprise of the same scale. Retail chain stores have the same equipment requirements for product display and storage as retail enterprises.
5, drug retail chain enterprises should set up a separate, convenient distribution activities to carry out distribution places.
(four), the establishment and requirements of drug testing room
1. The pharmaceutical business department has a pharmaceutical inspection department suitable for its business scale and scope, and is equipped with corresponding inspection instruments and equipment. Management of Chinese herbal medicines and Chinese herbal pieces should also set up a Chinese herbal medicine specimen room (cabinet).
2、
Drug inspection rooms set up by pharmaceutical wholesale and retail chain enterprises shall have special places for instrument analysis, chemical analysis and titration solution calibration, and have safety facilities and temperature and humidity adjustment equipment for working in flammable, explosive and toxic environments. The area of drug testing room shall not be less than150m2; For large enterprises; Medium-sized enterprises shall not be less than100m2; ; Small business, 50M2.
3, drug testing room should carry out chemical determination, instrument analysis and other inspection items, and equipped with instruments and equipment suitable for the scale and variety of enterprises.
(1) Small enterprises-equipped with110000 analytical balance, acidity meter, electrothermal constant-temperature drying oven, constant-temperature water bath pot, tablet disintegrator and clarity detector. Chinese herbal medicines and decoction pieces should also be equipped with moisture analyzer, ultraviolet fluorescent lamp and microscope.
(2) Medium-sized enterprises-On the basis of small-sized enterprises, automatic polarimeter, ultraviolet spectrophotometer, biochemical incubator and high pressure are added.
Sterilization pot, high-temperature table, clean workbench, high-power microscope. Management of Chinese herbal medicines, Chinese herbal pieces should also be equipped with a biological microscope.
Mirror.
(3) Large enterprises-On the basis of small and medium-sized enterprises, tablet dissolution apparatus, vacuum drying oven and constant temperature and humidity incubator are added.
(5), acceptance maintenance room
1、
Drug wholesale and retail chain enterprises should set up inspection and maintenance rooms in the warehouse, and the area requirements should generally reach: large enterprises should not be less than 50 M2；; ; Medium-sized enterprises are not less than 40m2, and small enterprises are not less than 20m2.
2、
Equipment requirements: the acceptance maintenance room should have necessary moisture-proof and dust-proof equipment. If the warehouse doesn't have a drug testing room or can't use the instruments and equipment with a testing room, you can cultivate 1/1000 balance, clarity 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.
Requirements of GSP certification for institutions and personnel
(A) quality management institutions and responsibilities
1, pharmaceutical wholesale and retail chain enterprises should establish a leadership team headed by the main person in charge, including
Quality leading institutions, including the heads of business departments such as procurement, sales, storage and transportation, and the heads of enterprise quality management institutions. The organization shall undertake the following quality management functions:
1)
Organize and supervise enterprises to implement the drug administration law of People's Republic of China (PRC) and other drug administration laws, regulations and administrative rules;
2) Organize and supervise the implementation of enterprise quality policy;
3)
Establish enterprise quality system;
4) Responsible for establishing enterprise quality management departments and determining the quality management functions of each department;
5) examine and approve the enterprise quality management system;
6)
To study and decide on major issues of enterprise quality management;
7) determine the enterprise quality reward and punishment measures;
8) Ensure that the enterprise will only exercise its functions and powers to the management personnel in the coming year.
2、
Drug wholesale and chain enterprises should set up a quality management organization, which consists of a quality management group and a quality acceptance group. Wholesale enterprises and retail chain enterprises that purchase goods directly from factories should also set up drug inspection rooms.
Wholesale and retail chain enterprises should set up maintenance institutions according to the scale of operation. Large and medium-sized enterprises should set up drug maintenance groups, and small enterprises should set up drug maintenance groups or drug maintenance personnel. The maintenance team or repairman accepts the supervision and guidance of the quality management organization in business.
3. The main responsibilities of the quality management institutions of pharmaceutical wholesale and retail chain enterprises are:
1) Implement the laws, regulations and administrative rules related to drug quality management;
2)
Draft the enterprise drug quality management system and guide and supervise the implementation of the system. Have the right to decide the quality of drugs within the enterprise;
3) Responsible for the quality audit of the first camp enterprises and the first camp varieties;
4)
Be responsible for establishing the quality files of drugs handled by enterprises, including quality standards;
5) Be responsible for the inquiry of drug quality and the investigation, handling and reporting of drug quality accidents or quality complaints;
6)
Responsible for the acceptance and inspection of drugs, and guide and supervise the quality work in the storage, maintenance and transportation of drugs;
7) Be responsible for the audit of unqualified drugs and supervise the treatment process of unqualified drugs;
8) Collect and analyze drug quality information;
9) Assist in the education or training of enterprise employees in drug quality management.
(2) Personnel and training requirements
1, the main person in charge of the enterprise should have professional titles and be familiar with the laws, regulations and rules of the state on drug management and the knowledge of drugs handled.
2, the person in charge of the enterprise should have a pharmaceutical professional and technical titles, responsible for quality management;
3, the person in charge of the enterprise quality management organization, should be a professional pharmacist or have the corresponding pharmaceutical professional and technical titles, and can adhere to the principle, have practical experience, can independently solve the quality problems in the process of operation. The specific requirements for professional titles are as follows:
1) person in charge of quality management of pharmaceutical wholesale and retail chain enterprises:
●
Large and medium-sized enterprises should have the technical titles of pharmacist in charge (including pharmacist in charge, pharmacist in charge) or engineer (including) in pharmacy-related majors (referring to medicine, biology, chemistry, etc.);
●
Small enterprises-should have the technical titles of pharmacists (including pharmacists and traditional Chinese medicine pharmacists) or assistant engineers (including) or above in pharmacy-related majors;
●
The person in charge of quality management of cross-regional chain retail enterprises should be a licensed pharmacist.
● The person in charge of the quality management organization of wholesale and retail chain enterprises should be a licensed pharmacist or meet the above conditions.
2) The person in charge of the drug inspection department of a drug wholesale and retail chain enterprise shall meet the corresponding conditions specified in 1).
3) The staff engaged in quality management and inspection of pharmaceutical wholesale and retail chain enterprises should have the technical titles of pharmacists (including pharmacists and traditional Chinese medicine pharmacists) or above, or have the technical secondary school (including) or above in pharmacy or related majors. The above personnel should receive professional training.
Training and passing the examination by the provincial drug supervision and administration department, and obtaining the post qualification certificate before taking up the post. Personnel engaged in quality management and inspection should be on-the-job personnel and not part-time.
4) Personnel engaged in drug acceptance, maintenance, measurement and sales in pharmaceutical wholesale and retail chain enterprises should have a high school education or above. The above-mentioned personnel shall be trained and assessed by the drug supervision and administration department at or above the prefecture level, and they shall not be employed until they have obtained the post qualification certificate.
5) Full-time personnel engaged in quality management, inspection, acceptance and maintenance measurement in pharmaceutical wholesale enterprises shall not be less than 4% of the total number of employees in enterprises, and such personnel in retail chain enterprises shall not be less than 2% of the total number of employees and remain stable.
(six) personnel engaged in quality management and inspection in pharmaceutical wholesale and retail chain enterprises shall receive continuing education organized by provincial pharmaceutical supervisory and administrative departments every year; Personnel engaged in acceptance, maintenance and measurement should regularly receive continuing education organized by enterprises, and files should be established for the continuing education of the above personnel.
7) Personnel who are in direct contact with the quality management, drug inspection, acceptance, maintenance and storage of drugs in pharmaceutical wholesale and retail chain enterprises shall undergo health examination every year and establish files.
4. Training requirements
1)
Employees engaged in drug quality management, inspection, acceptance, storage, maintenance and business of enterprises shall be trained and certified after passing the examination. For positions with national employment access regulations, staff members must pass vocational skills appraisal and obtain vocational qualification certificates before taking up their posts.
System and management requirements of GSP certification
(1) Rules and regulations on drug quality management
Drug wholesale and chain enterprises should establish a quality management system including the following basic contents
1, quality policy and management by objectives;
2、
Quality system audit;
3. Quality responsibilities of relevant departments, organizations and personnel;
4, the provisions of the quality veto;
5. Quality information management;
6、
Review the first camp enterprises and the first camp varieties;
7. Quality acceptance and inspection management;
8. Management of warehousing, maintenance and outbound audit;
9、
Management of relevant records and vouchers;
10, special drug management;
1 1. Management of expired drugs, unqualified drugs and returned drugs;
12, Management of quality accidents, quality inquiries and quality complaints;
13, provisions on reporting of adverse drug reactions;
14, Health and Personnel Health Management;
15, quality education, training and assessment regulations;
(2) Quality management of purchased goods
1. In order to ensure the quality of incoming goods, the purchasing link should organize incoming goods according to the following procedures.
1) Confirm the legal qualification and quality reputation of suppliers;
2) Review the legality and quality reliability of purchased drugs;
3)
Verify the legal qualifications of the sales staff of suppliers who have business contacts with the capital industry;
4)
For the first variety, fill in the "First Drug Audit Form", which will be audited by the enterprise quality management organization and the competent leaders of the enterprise;
5) Sign a procurement contract with clear quality terms;
6)
Quality clauses in purchase contracts.
2, the first camp variety legitimacy and quality content audit.
1) Verify the drug approval number and obtain the quality standard;
2)
Check whether the packaging, labels and instructions of drugs meet the requirements;
3) Understand the performance, use, inspection methods, storage conditions and quality reputation of drugs.
3, in the purchase and sale contract should be clear about the quality terms:
1) In the industrial and commercial purchase and sale contract:
① The drug quality meets the quality standards and relevant quality requirements;
(2) Drugs with product certificate;
(3) The drug packaging conforms to the relevant regulations and the requirements of cargo transportation.
2) in the purchase and sale contract between businessmen:
① The drug quality meets the quality standards and relevant quality requirements;
(2) Drugs with product certificate;
(3) When purchasing imported drugs, the supplier shall provide documents that meet the requirements;
(4) The drug packaging complies with the relevant regulations and the requirements for cargo transportation.
4, establish a complete record of drug procurement.
1)
The contents of the record shall include: name, dosage form, specification, validity period, manufacturer, supplier, purchase quantity, purchase date, etc. Drugs;
2)
Storage time of drug purchase records: the storage time should be longer than 1 year, but not less than 3 years.
(3) Quality management of drug acceptance
1, drug quality acceptance
1) Quality acceptance content:
(1) drug appearance inspection;
(2) Inspection and identification of internal and external packaging of drugs, mainly including:
(1) in each package, there should be a product certificate;
(2) The name and address of the manufacturer, the name, specification, approval number, production date and expiration date of the drug are indicated on the label and attached instructions of the drug package; The label or instruction should also include the ingredients, indications or functional indications, usage, dosage, emergency, adverse reactions, precautions and storage conditions of the drug;
(3) The labels or instructions of drugs under special management and drugs for external use shall have the specified marks 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.
(4) For imported drugs, the name, main components and registration number of the drug shall be indicated in Chinese on the packaging label, and there shall be instructions in Chinese. Imported drugs should have a copy of the registration certificate of imported drugs and an inspection report of imported drugs that meet the requirements; 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 quality inspection agency or quality management agency of the freight unit.
⑤ Chinese herbal medicines and Chinese herbal pieces should be packaged and marked with qualified quality. 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.
2) Make acceptance records. Records shall record the supplier, quantity, arrival date, product name, dosage form, specification, approval number, batch number, manufacturer, validity period, quality status, acceptance conclusion, acceptance personnel, etc.
3) For the drugs returned after sale, the inspector shall check and accept them according to the purchase acceptance regulations, and send them to the inspection department for sampling inspection when necessary.
4) Specially managed drugs shall be subject to the double acceptance system.
2. Drug inspection
1)
Internal quality inspection should be carried out on the first variety. If some projects have no inspection ability, they should ask the production enterprise for the quality inspection report of this batch of drugs, or send it to the drug inspection institute at or above the county level for inspection.
2)
The number of batches of drug sampling inspection shall not be less than 1 of the total number of batches purchased by large and medium-sized enterprises. 5%, small enterprises should not be less than 1% of the total procurement.
3)
Drug inspection should have a complete original record, and the data should be accurate, the content should be true, the handwriting should be clear, and the format and language should be standardized. Records shall be kept for 5 years.
3、
Acceptance and inspection instruments: Instruments, measuring instruments and titration solutions used for drug acceptance, inspection and maintenance should have use records and periodic verification records.
(4) Quality management in storage and maintenance
1, quality management in drug storage.
1)
Stored drugs should be piled up in a centralized way according to their numbers. Drugs within the validity period should be classified and stored relatively centrally, stacked in sequence or separately according to the batch number and the validity period distance, and clearly marked. For drugs approaching the expiration date, the expiration date report should be filled out every month.
2) Drugs and drugs, internal medicine and external medicine, prescription drugs and over-the-counter drugs should be stored separately; Drugs, Chinese herbal medicines, Chinese herbal pieces and easily smelled dangerous goods should be stored separately from other drugs.
3) The medicines should be stacked at a certain distance. The distance between drugs and walls and roofs 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) Drug storage should be managed by color code. The color code should be: the drug waiting area and the drug return area are yellow; The qualified drug area, the zero-goods weighing area and the drug area to be sent are green; The unqualified drug area is red.
5)
Drugs returned after sale shall be collected with the return certificate issued by the sales department, stored in the return area, kept by special personnel and recorded. Accepted drugs can only be stored in the qualified drug warehouse (area) after being recorded by the keeper; Unqualified drugs shall be recorded by the keeper and put into the unqualified drug warehouse (area). Return records shall be kept for 3 years.
6) Unqualified drugs shall be stored in unqualified warehouses (areas) and clearly marked. There should be perfect procedures and records for the confirmation, reporting, loss reporting and destruction of unqualified drugs.
7)
Drugs should be stored in the corresponding warehouse according to the requirements of temperature and humidity.
8) Handling and stacking shall strictly comply with the requirements of graphic signs on drug packaging and standardize operation. The stacking height of drugs that are afraid of pressure should be controlled and turned over regularly.
2. Maintenance of drug quality during storage.
1) Main responsibilities of drug maintenance:
(1) Instruct warehouse personnel to store drugs reasonably;
(2) Check the storage of drugs in the warehouse and cooperate with the storekeeper to manage the temperature and humidity of the warehouse.
③ Regularly check the quality of drugs in stock and make inspection records;
④ According to their characteristics, Chinese herbal medicines and Chinese herbal pieces are cured by drying, deoxidation and fumigation.
(5) Chinese herbal medicines that may have quality problems due to abnormal reasons and have been in storage for a long time should be sampled for inspection;
⑥ Inform the quality management organization in time to review the problems found in the inspection;
⑦ Regularly summarize, analyze and report quality information, such as maintenance inspection, drugs near the expiration date or long-term storage, etc.
Responsible for the management of maintenance instruments and equipment, temperature and humidity monitoring instruments, measuring instruments and in-use instruments in the warehouse;
Pet-name ruby establish drug maintenance files.
2) The drugs in stock should be regularly maintained and inspected according to the circulation situation, and recorded. During the inspection, drugs that may have problems due to abnormal reasons, perishable drugs, and Xianglinsao batch drugs with quality problems were stored for a long time.
These drugs should be sampled for inspection.
3) If quality problems are found in inventory maintenance, obvious signs should be hung, delivery should be suspended, and the quality management or delivery certificate should be notified as soon as possible to check the quality and quantity of the physical objects. When the following problems are found, the delivery or distribution should be stopped and reported to the relevant departments for handling.
4) 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 warehouse exceed the specified range, control measures should be taken in time and recorded.
(5) Quality management of delivery and transportation.
1, quality management of outbound links
1) The principle of "first-in, first-out", "first-out in the near future" and delivery by batch number should be followed;
2) Drug distribution should be rechecked and quality checked. Narcotic drugs, psychotropic drugs and toxic drugs for medical use shall establish a double review system;
3)
Drug quality tracking records should be carried out when leaving the warehouse to ensure fast and accurate quality tracking. Records shall be kept for more than one year, but not less than three years;
4) When the drugs are delivered out of the warehouse, quality inspection and quantity counting shall be carried out on the physical objects according to the delivery or distribution vouchers. Stop delivery or distribution when the following problems are found, and report to the relevant departments for handling:
①
Drug packaging has abnormal sound and liquid leakage;
(2) the outer packaging is damaged, the seal is not firm, the gasket is not solid, and the seal is seriously damaged;
(3) The packaging label is fuzzy or falls off;
④ The drug has expired.
5) Consistency records made by pharmaceutical wholesale enterprises for the convenience of quality tracking should include items such as purchasing unit, product name, dosage form, specification, batch number, expiration date, manufacturer, quantity, sales date, quality status and auditor.
6) When the pharmaceutical retail chain enterprises leave the warehouse, they shall conduct quality inspection and re-inspection in accordance with the regulations.
7) Its compliance records include the name, dosage form, specification, batch number, expiration date, manufacturer, quantity, delivery date, delivery shop name and compliance personnel of the drug.
2. Quality management during transportation.
1) For the transportation of drugs with temperature requirements, necessary heat preservation or cold storage measures should be taken according to seasonal temperature changes and transportation distance;
(2) The transportation of narcotic drugs, psychotropic drugs of Category I, toxic drugs for medical use and dangerous goods shall be handled in accordance with relevant regulations;
3) When the drugs are directly mixed by the production enterprise, they can be shipped only after the quality inspection of the business unit is qualified;
4) When handling, loading and unloading drugs, they 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.
5) When transporting drugs, corresponding measures should be taken according to the packaging and road conditions of the transported drugs to prevent the drugs from being damaged and confused. When transporting drugs with temperature requirements, corresponding insulation or refrigeration measures should be taken on the way.
(six) quality management in drug sales and after-sales service.
1. Enterprises shall sell drugs to legally qualified units in accordance with the provisions of relevant laws, regulations and rules;
2, sales of special management of drugs should be strictly in accordance with the relevant provisions of the state;
3, sales staff should correctly introduce drugs, and shall not exaggerate and mislead users;
4. Sales should issue legal bills, establish sales records according to regulations, and ensure that tickets, accounts and goods are consistent. Sales documents and records shall be kept as required.
5. For drugs directly transferred from other commercial enterprises due to special needs, this enterprise shall ensure the quality of drugs and make relevant records in time;
6, drug marketing publicity should strictly implement the national laws and regulations on advertising, publicity content must be approved by the state drug supervision and administration department of drug use instructions shall prevail;
7. 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 measures and make records;
8, enterprises have sold drugs, if there are any quality problems, should report to the relevant administrative departments, and timely recovery of drugs and make records.
GSP is a technical barrier to drug market access. Hehe, I hope it helps you.