(a), the warehouse and environmental requirements
1, the enterprise should be compatible with its scale of operation of the warehouse. Its area (floor area) should meet the following requirements: large enterprises not less than 1500M2, medium-sized enterprises not less than 1,000M2, small enterprises less than 500M2.
2, the requirements of the warehouse environment: the ground should be flat, no water and weeds, no pollution sources.
3, the warehouse should be able to meet the following requirements: library site and security requirements:
1) site requirements: drug storage operation area, auxiliary operation area, office life should be separated from a certain distance or isolation measures, loading and unloading operations should be roofed.
2) warehouse building requirements: the warehouse has a suitable classification of drugs for safekeeping and in line with the drug storage requirements of the warehouse. Storehouse walls, roof and ground clean, smooth, tightly structured doors and windows.
3) safety and fire requirements: the warehouse should meet the requirements of the fire, safety measures.
4, the warehouse has a reasonable functional partition. Warehouse should be divided into a warehouse to be examined (area), qualified goods library (area), shipping library (area), non-qualified goods library (area), return library (area) and other specialized places, the operation of Chinese medicine tablets should also be divided into a special library of zero cargo weighing (area). The library area should be set up obvious signs.
Note: The above large-scale pharmaceutical wholesale and retail chain enterprises, refers to annual drug sales of more than 200 million yuan; medium-sized enterprises refers to annual drug sales of 50 million yuan to 200 million yuan; small enterprises refers to annual drug sales of less than 50 million yuan;
(B), warehouse facilities and equipment requirements
1, to keep the drugs and the ground a certain distance between the equipment. A certain distance between the ground and the equipment;
2, light, ventilation and drainage equipment;
3, detection and adjustment of temperature and humidity equipment;
4, dust, moisture, mold, pollution and pest control, rodent, bird and other equipment;
5, in line with the safety of electricity requirements of the lighting equipment;
6, suitable for the demolition and consolidation of the workplace and packaging materials such as Shipment of workplaces and packaging materials and other storage places and equipment.
7, drug wholesalers and retailers according to the storage requirements of the drugs operated, should be set up in different temperature and humidity conditions of the warehouse. One of the cold storage temperature should be 2 ~ 10 ℃; cool library temperature does not exceed 20 ℃; room temperature library temperature of 0 ~ 30 ℃; the relative humidity of the library should be maintained between 45 ~ 75%.
8, the storage of narcotic drugs, a class of psychotropic drugs, medical drugs, toxic drugs, emissive drugs should be a special warehouse and have the appropriate security measures.
(C), business facilities, equipment and requirements
1, drug retailers should have a business premises and drug warehouses compatible with the scale of operation, and the environment is clean, free of pollutants, temperature and humidity regulation equipment. Business premises, warehouses, office life and other areas of the enterprise should be separated.
2, the area of the business premises and warehouses of the retail drug requirements:
① large-scale retail business premises area of 100M2, warehouse 30M2;
② medium-sized retail business premises area of 50M2, warehouse 20M2;
③ small retail business premises area of 40M2, warehouse 20M2;
④ retail chain stores business premises area of 40M2.
3, drug retailers business premises and drug warehouses should be configured with equipment:
①
drug retailers and retail chain stores business premises should be spacious, clean, business shelves, counters, sales cabinets signage is conspicuous;
②
drug retailers and retail chain stores should be spacious and clean, business shelves, counters, sales cabinets signage is conspicuous;
②
drugs Retail enterprises and retail chain stores should be equipped with intact scales and clean and hygienic drug transfer tools, packaging supplies, and configure low-temperature preservation of all products according to the need for refrigeration equipment;
③
Retail enterprises and retail chains of sales of special management of medicines should be configured to store the special management of the special drugs in special cabinets and custody of the equipment, tools, etc.
④ necessary drug testing, inspection, maintenance and repair of the drug. ④ Necessary drug testing, acceptance, maintenance equipment;
⑤ Testing and adjusting the temperature and humidity equipment;
⑥ To maintain a certain distance between the drugs and the ground equipment;
⑦ Drugs, dust, moisture, pollution and insect, rodent, mildew, and other equipment;
The operation of traditional Chinese medicine tablets necessary for the dispensing of prescriptions and prescription concoctions of the equipment;
4. Retail chain stores, product display, storage and other equipment requirements and retail enterprises with the same.
5, drug retail chain enterprises should set up a separate, convenient distribution activities to carry out the distribution of goods place.
(D), the drug testing room set up and requirements
1, the drug business sector with the scale and scope of operation of the drug testing department, and configure the appropriate testing instruments and equipment. Business Chinese herbal medicines and Chinese herbal medicines should also be set up in Chinese medicine specimen room (cabinet).
2,
Pharmaceutical wholesale and retail chain enterprises set up drug testing room should be used for instrumental analysis, chemical analysis, titrant calibration of the special place, and for flammable, explosive, toxic and other environmental operations in the safety facilities and temperature, humidity and air-conditioning equipment. Drug testing room area, large enterprises not less than 150M2; medium-sized enterprises not less than 100M2; small enterprises not less than 50M2.
3, the drug testing room should be carried out in the chemical determination, instrumental analysis and other testing projects, and is equipped with the size of the enterprise and business varieties of instruments and equipment appropriate.
① small enterprises - the configuration of one-ten-thousandth analytical balance, acidity meter, electric thermostatic drying oven, thermostatic water bath, tablet disintegration meter, clarity detector. Business Chinese herbs and tablets, should also be configured moisture meter, ultraviolet fluorescent lamps and microscopes.
② medium-sized enterprises - in small enterprises on the basis of the configuration, increase the autorotator, ultraviolet spectrophotometer, biochemical incubator, high pressure
sterilization pot, high temperature table, ultra-clean bench, high power microscope. Management of Chinese herbal medicines, traditional Chinese medicine should also be equipped with biological microscope
mirror.
③ large enterprises - in small and medium-sized enterprises on the basis of configuration, increase the tablet dissolution meter, vacuum drying oven, constant temperature wet incubator.
(E), acceptance care room
1,
Pharmaceutical wholesale and retail chain enterprises should be set up in the warehouse acceptance care room, its area requirements should be generally reached: large enterprises not less than 50 M2; medium-sized enterprises no less than 40 M2; small enterprises no less than 20 M2;
2,
Equipment requirements: Acceptance care room should have the necessary moisture-proof, dust-proof. Have the necessary moisture-proof, dust-proof equipment. If the warehouse is not set up in the pharmaceutical inspection room or can not be used with the inspection room *** with instruments and equipment for the hemp fly cultivation one-thousandth of a balance, clarity tester, standard colorimetric solution. Enterprises operating Chinese herbal medicines, traditional Chinese medicine tablets should also be equipped with moisture meter, ultraviolet fluorescent lamp, dissecting mirror or microscope.
GSP certification requirements for institutions and personnel
(a) quality management organizations and responsibilities
1, the wholesale and retail chain of pharmaceutical enterprises should be set up to the main person in charge, including
Incoming, sales, storage and transportation and other heads of the business sector and the head of the enterprise quality management organization, including the quality of the leadership organization. The organization shall undertake the following quality management functions:
1)
Organize and supervise the implementation of the Chinese People's Republic of China Drug Administration Law and other drug management laws, regulations and administrative regulations;
2) Organize and supervise the implementation of the enterprise's quality policy;
3)
Establish the enterprise's quality system;
4) Responsible for the establishment of enterprise quality management department, determine the quality management function of each department;
5) Finalize the enterprise quality management system;
6)
Study and determine the major issues of enterprise quality management work;
7) Determine the quality of the enterprise incentives and penalties;
8) Ensure that the enterprise only to come to the sense of the management staff to exercise the authority of the staff.
8) Ensure that the enterprise only come to the annual management staff to exercise their powers.
2,
Drug wholesalers and chain enterprises should set up quality management organization, the organization set up under the quality management group, quality acceptance group. Wholesale enterprises and retail chain enterprises directly from the factory should also set up a pharmaceutical inspection room.
Wholesale and retail chain enterprises should be set up according to the scale of operation of the conservation organization. Large and medium-sized enterprises should set up a drug maintenance group, small enterprises to set up a drug maintenance group or drug maintenance staff. Conservation group or conservationist in the business to accept the supervision and guidance of the quality management organization.
3, wholesale and retail drug chain enterprise quality management organization's main functions are:
1) the implementation of laws, regulations and administrative regulations relating to drug quality management;
2)
Drafting of the enterprise drug quality management system, and guidance, supervision and implementation of the system. In the enterprise has the right to rule on the quality of drugs;
3) responsible for the first enterprise and the first varieties of quality audit;
4)
responsible for the establishment of the enterprise's business drugs and quality standards and other elements of the quality of the file;
5) is responsible for the quality of the drug query and the quality of the drug quality accidents or complaints about quality of the investigation, processing and reporting;
6)
Drafting of drug quality management system, and guidance, supervision and implementation of the system. p> 6)
Responsible for the acceptance and inspection of drugs, guidance and supervision of drug storage, maintenance and transportation in the quality of work;
7) responsible for the quality of unqualified drugs audit, the unqualified drugs to implement the supervision of the process of handling;
8) collect and analyze information on the quality of medicines;
9) to assist in carrying out on the enterprise staff drug quality management of education or training.
8) Collect and analyze drug quality information.
(B) personnel and training requirements
1, the main person in charge of the enterprise should have professional and technical titles, familiar with the national laws, rules and regulations on drug management, and the knowledge of the drug business.
2, the person in charge of the enterprise should have a professional and technical title in pharmacy, responsible for quality management;
3, the person in charge of the enterprise quality management organization, should be a professional pharmacist or have the appropriate professional and technical title in pharmacy, and can adhere to the principle of practical experience, and can independently solve the problem of quality of the business process. Specific requirements regarding professional and technical titles are as follows:
1) Pharmaceutical wholesale and retail chain enterprises responsible for quality management work:
●
Large and medium-sized enterprises - should have the pharmacist in charge (including the pharmacist in charge, the pharmacist in charge of the Chinese pharmacist) or pharmacy-related professions (referring to medicine, biology, chemistry and other professions) engineers (including) or more technical titles;
●
Small enterprises - should have the technical title of pharmacist (including pharmacist, Chinese pharmacist) or assistant engineer (including) or above in pharmacy-related professions;
●
The person in charge of quality management work of retail chain enterprises operating across geographical regions - should be a licensed pharmacist.
● Wholesale and retail chain enterprises responsible for quality management organization - should be a licensed pharmacist or meet the above conditions.
2) The person in charge of the drug inspection department of the pharmaceutical wholesale and retail chain enterprises - should meet the corresponding conditions specified in 1).
3) Drug wholesalers and retail chain enterprises engaged in quality management and inspection of staff - should have a pharmacist (including pharmacists, Chinese pharmacists) or above the technical title, or with secondary school (including) or above the degree of pharmacy or related professional. The above personnel should be qualified by professional training
The provincial drug supervision and management department exams, and obtain a certificate of qualification before taking up the post. Personnel engaged in quality management and inspection work should be on duty, shall not be part-time personnel.
4) pharmaceutical wholesale and retail chain enterprises engaged in drug acceptance, maintenance, measurement and sales of personnel - should have a high school (including) above the cultural level. The above personnel should be qualified by the post training and examination of the drug supervision and management department at or above the municipal level (inclusive), and then obtain the post qualification certificate before being allowed to take up their duties.
5) pharmaceutical wholesalers engaged in quality management, inspection, acceptance, maintenance of several measurement of the number of full-time staff not less than 4% of the total number of employees, retail chain enterprises such personnel not less than 2% of the total number of employees, and to maintain stability.
6) pharmaceutical wholesalers and retail chain enterprises engaged in quality management, inspection of personnel, each year should be subject to the provincial drug supervision and management department of the organization of continuing education; engaged in acceptance, maintenance, measurement and other work of the personnel, should be subject to the regular organization of the continuing education of the enterprise, the continuing education of the above personnel should be established files.
7) pharmaceutical wholesale and retail chain enterprises in the quality management, drug testing, acceptance, maintenance, storage and other direct contact with the drugs of the position of the work of the personnel, the annual health examination and the establishment of files.
4, training requirements
1)
Enterprises engaged in drug quality management, inspection, acceptance, storage, maintenance, business and other staff should be trained, qualified and licensed. For positions for which the state has employment access regulations, staff members are required to pass vocational skills appraisal and obtain vocational qualification certificates before being allowed to take up their posts.
GSP certification on the system and management requirements
(a) Drug quality management rules and regulations
Drug wholesalers and chains should develop a quality management system that includes the following basic elements
1, quality policy and target management;
2,
Quality system review;
3, the relevant departments, organizations and personnel of the quality responsibility;
3, the relevant departments, organizations and personnel. p>
Management of relevant records and vouchers;
10, the management of special management of drugs;
11, the management of expiration date drugs, unqualified drugs and returned drugs;
12, the management of quality accidents, quality inquiries and quality complaints;
13, the provisions of the report of adverse drug reactions;
14, the management of hygiene and Management of personnel health status;
15, quality education, training and assessment requirements;
(B) quality management in the purchase
1, in order to ensure the quality of goods purchased, the procurement process should be organized in accordance with the following procedures for purchasing
1) Confirmation of the legal qualifications of the supplier company and the quality of reputation;
2) audit of the purchased medicine legality and quality and reliability;
2) the purchase of drugs Legitimacy and quality reliability;
3)
and the money industry to carry out business contacts with the sales staff of the supply unit, to verify the legal qualifications;
4)
for the first varieties of business, fill out the "first time business drug audit form", and by the quality management organization and the competent leadership of the enterprise audit approval;
5) signed a clear quality terms of purchase contract;
6) the purchase of goods and the quality of the goods and the quality of the goods and services.
6)
Quality terms in the purchase contract.
2, the legality of the first camp varieties and the quality of the contents of the audit.
1) verify the approval number of the drug and obtain quality standards;
2)
audit the drug packaging, labeling, instructions, etc. are in line with the provisions;
3) understanding of the performance of the drug, the use of the test method, the storage conditions, as well as the quality of the credibility of the content.
3, in the purchase and sale contract should be clear quality terms:
1) in the industrial and commercial purchase and sale contract:
① drug quality in line with quality standards and quality requirements;
② drugs with product certification;
③ drug packaging in line with the relevant provisions and requirements for the transportation of goods.
2) in the purchase and sale contract between merchants:
① drug quality in line with quality standards and relevant quality requirements;
② drugs with product certification;
③ purchase of imported medicines, the supply side should provide certificates and documents to comply with the provisions of the regulations;
④ drug packaging in line with the relevant provisions of the regulations and requirements for the transportation of goods.
4, the establishment of a complete record of drug purchases
1)
Record content should include: the name of the drug, dosage form, specifications, expiration date, manufacturer, supplier, purchase quantities, date of purchase, etc.;
2)
Pharmaceutical purchases record retention time: it should be preserved for more than the expiration date of the drug for one year, but not less than three years. years.
(C) the quality of drug acceptance and inspection
1, drug quality acceptance
1) quality acceptance content:
(1) the appearance of the drug traits check;
(2) the inspection of the drug inner and outer packaging and labeling, the main contents include:
① each package, there should be a product certification;
② Drug packaging labels and accompanying instructions, the name and address of the manufacturer, the name of the drug, specifications, approval number, production date, expiration date, etc.; labels or instructions should also be the composition of the drug, indications or indications, usage, dosage, emergency a, adverse reactions, precautions, and storage conditions, etc.;
③ special management of medicines, drugs for external use of the label or instructions There should be a prescribed labeling and warning instructions. Prescription drugs and non-prescription drugs in accordance with the requirements of classification management, labeling, instructions on the corresponding warning or advice; non-prescription drug packaging has the state's proprietary logo.
④ 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. Imported drugs should be in line with the provisions of the "Certificate of Registration of Imported Drugs" and "Imported Drugs Inspection Report" copy; imported prophylactic biological products, blood products should be "import approval of biological products" copy; imported medicinal herbs should be "imported medicinal herbs approval" copy. The above approval documents should be home the **** goods unit quality inspection agency or quality management organization of the original seal.
⑤ Chinese herbal medicines and Chinese medicine should be packaged with a quality mark. On each package, the 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 medicinal herbs, in the package should also be marked with the approval number.
2) Make a good acceptance record. 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 conclusion and acceptance of personnel.
3) The sale of drugs returned after the acceptance of personnel in accordance with the provisions of the purchase and acceptance of acceptance, if necessary, samples should be sent to the inspection department for testing.
4) The special management of drugs, should be implemented in two-person acceptance system.
2, drug testing
1)
The first varieties should be carried out on the internal quality inspection. Certain items, such as the lack of testing capacity, should be requested from the manufacturer of the batch number of the quality inspection report of the drug, or sent to the county above the drug testing center inspection.
2)
The number of batches of drugs sampling test, large and medium-sized enterprises should not be less than the total number of batches of 1. 5%, small enterprises should not be less than 1% of the total number of batches of goods.
3)
The drug test should be a complete record of the original, and to the data is accurate, the content is true, clear handwriting, format and terminology standardization. Records are kept for 5 years.
3,
Acceptance, inspection instruments: for drug acceptance, inspection, maintenance of instruments, measuring instruments and titrant, etc., there should be the use and regular calibration records.
(D) storage and maintenance of quality management
1, the quality of drug storage management.
1)
Stored medicines should be stacked centrally by number. The expiration date of the drugs should be categorized relatively centralized storage, according to the lot number and the validity of the near and far sequential or separate stacking and have a clear sign. Nearly expiration date of the drug, should be filled out monthly expiration date statement.
2) Drugs and medicines, internal and external medicines, prescription drugs and non-prescription drugs should be stored separately; easy to cascade the flavor of the drugs, Chinese herbal medicines, traditional Chinese medicine, as well as dangerous goods should be stored separately from other drugs.
3) The stacking of drugs should leave a certain distance. Drugs from the wall, the roof of the spacing is not less than 30cm, and the warehouse radiator or heating pipe spacing is not less than 30cm, and the ground spacing is not less than 10cm.
4) Drug storage should implement color-coded management. The color code should be as follows: yellow for the eye drug area and the return drug area; green for the qualified drug area, the zero goods weighing area and the drug area to be issued; red for the unqualified drug area.
5)
The drugs returned after the sale, with the return voucher issued by the sales department to receive the goods, stored in the return area, stored by a person and make a good record of the return. Acceptance of qualified drugs, recorded by the custodian before being deposited into the qualified drugs library (area); unqualified drugs by the custodian record into the unqualified drugs library (area). Return records should be kept for three years.
6) Unqualified drugs should be stored in the unqualified library (area), with obvious signs. Unqualified drugs should be recognized, reported, reported loss, destruction should be perfect procedures and records.
7)
Drugs should be stored in the appropriate library according to the requirements of temperature and humidity.
8) Handling and stacking should strictly comply with the requirements of the drug packaging labeling, standardized operation. Fear of pressure medicines should control the stacking height, regular stacking.
2, in the storage period of the quality of drug conservation.
1) the main responsibilities of the drug conservation work:
① guidance to the custodian of the reasonable storage of drugs;
② check the storage conditions of the drugs in the warehouse, with the custodian of the temperature and humidity of the warehouse and other management.
③ Regular quality inspection of stock medicines, and make records of inspection;
④ According to the characteristics of Chinese herbal medicines and Chinese herbal medicines, take drying, oxygen reduction, fumigation and other methods of conservation;
⑤ Due to the abnormal causes of the quality of the collateral may be a problem and the storage of Chinese herbal medicines for a longer period of time, samples should be sent to the inspection;
⑥ The problems found during the inspection Timely notification of the quality management organization to review and deal with;
⑦ Regularly summarize, analyze and report the conservation inspection, near expiration date or long storage of drugs and other quality information.
⑧ is responsible for the maintenance of instruments and equipment, temperature and humidity detection and monitoring instruments, warehouses in the management of measuring instruments and appliances, etc.;
⑨ the establishment of drug maintenance files.
2) stock of drugs should be based on the flow of regular maintenance and inspection, and make a record. Inspection, due to abnormal reasons may be problematic drugs, perishable drugs, has been found that the quality of the drugs thought Lin batch number of drugs, storage time is longer
drugs, should be sampled and sent for inspection.
3) Inventory maintenance if quality problems are found, should hang a clear sign and suspend shipments, and as soon as possible to notify the quality management or distribution vouchers on the physical quality checks and quantity checks. Found the following problems should be stopped when the shipment or distribution, and reported to the relevant departments to deal with.
4) should make good warehouse temperature and humidity monitoring and management. Daily should be on, afternoon each time regularly on the warehouse temperature and humidity records. If the warehouse temperature and humidity exceeds the prescribed range, it should take timely control measures and be recorded.
(E) the quality of the warehouse and transportation management
1, the quality of the warehouse link management
1) drugs out of the warehouse should follow the "first-in-first-out", "recent first-out" and according to the batch number of the principle of shipment;
2) drugs out of the warehouse should be double-checked and quality checks. Narcotic drugs, a class of psychotropic drugs, toxic drugs for medical use should establish a two-person verification system;
3)
Drugs out of the warehouse should be good quality tracking records of drugs to ensure that they can be quickly and accurately quality tracking. Records should be kept until more than one year beyond the expiration date of the drug, but not less than three years;
4) When the drugs out of the warehouse, the quality of the physical goods should be checked according to the proof of shipment or distribution and quantity checking. Found the following problems should stop delivery or distribution, and reported to the relevant departments:
①
abnormal ringing and liquid leakage in the packaging of medicines;
② the outer packaging is broken, sealing is not secure, lining is not solid, sealing is seriously damaged and other phenomena;
③ blurred or peeling packaging markings;
④ the drugs have exceeded the expiration date.
5) pharmaceutical wholesalers in the drugs out of the warehouse in line with the records made to facilitate quality tracking in line with the records should include the purchase unit, name, dosage form, specifications, lot number, expiration date, manufacturer, quantity, date of sale, quality status, review personnel and other items.
6) Pharmaceutical retail chain enterprises distribution out of the warehouse, should be in accordance with the provisions of a good quality inspection and review.
7) Its compliance records include the name of the drug, dosage form, specifications, batch number, expiration date, manufacturer, quantity, date of shipment, and the name of the drug sent to the store and comply with the personnel and other items.
2, quality management of the transportation process.
1) The transportation of temperature-demanding drugs should be based on the seasonal temperature changes and the journey to take the necessary thermal insulation or refrigeration measures;
2) Narcotic drugs, a class of psychotropic drugs, toxic drugs for medical use and the transportation of dangerous goods should be handled in accordance with the relevant provisions;
3) Direct transfer of medicines from the production company, the quality of the unit must be qualified by the operating unit before shipment; < /p>
4) Handling, loading and unloading of drugs should be gently, strictly in accordance with the requirements of the outer packaging labeling requirements of stacking and protective measures.
5) When drugs are transported, corresponding measures should be taken for the packaging conditions and road conditions of the transported drugs to prevent breakage and confusion of the drugs. Transportation of medicines with temperature requirements, the way should take appropriate thermal insulation or refrigeration measures.
(F) quality management in the sale of drugs and after-sales service
1, the enterprise should be in accordance with relevant laws, rules and regulations, the sale of drugs to the legally qualified units;
2, the sale of special management of drugs should be in strict accordance with the relevant provisions of the State;
3, the sales staff should be correctly introduced to the drugs, shall not be exaggerated and mislead the user;
3, the sales staff should be correctly introduced to the drugs, shall not be exaggerated and mislead the user;
4, the sales staff should be in accordance with the relevant provisions of the State. /p>
4, sales should be issued legal bills, and according to the provisions of the establishment of sales records, tickets, accounts, goods in line. Sales invoices and records should be kept in accordance with the provisions.
5, due to special needs from other commercial enterprises direct transfer of drugs, the enterprise should ensure that the quality of drugs, and make timely records;
6, drug marketing and publicity should be strictly enforced by the state laws and regulations on advertising, publicity must be based on the state drug regulatory authorities to approve the instructions for use of the drug;
7, the quality of the query, complaint, spot check and sales process found in the total, The quality of the total sales process found in the body to identify the causes, responsibilities, and take effective measures to deal with, and make a record;
8, the enterprise has been sold drugs such as found in the quality of the problem, should be reported to the relevant management, and timely recovery of drugs and make a good record.