GSP is the abbreviation of Good Supplying Practice, which is directly translated as Good Pharmaceutical Supply Practice, and is known as Good Pharmaceutical Practice in China. It refers to a management system that ensures that medicines meet quality standards in the process of medicine circulation, and is formulated for the links of planned procurement, purchase and acceptance, storage, sales and after-sales service. Its core is to restrain the behavior of enterprises through a strict management system, to carry out quality control on the whole process of drug operation, and to ensure the provision of high-quality drugs to users.
China began the drafting of GSP in 1982. After more than two years of hard work, in 1984, the China Pharmaceutical Company organized the development of "pharmaceutical commodity quality management specification (for trial implementation)", issued by the former State Administration of Pharmaceutical Affairs in the national pharmaceutical business on a trial basis. China's first set of GSP issued and implemented, causing the pharmaceutical business enterprises to pay extensive attention to many enterprises will GSP gradually into the track of enterprise development, making it an important part of business management. After a few years of trial, in 1991, the China Pharmaceutical Business Association organized a revision of the 1984 version of the GSP, 1992 by the former State Administration of Pharmaceutical Affairs formally issued and implemented, so that the GSP has become the government to implement the departmental regulations for the management of the pharmaceutical industry.
In 1998, the State Drug Administration was established, summed up more than a decade of experience in the implementation of the GSP, in the 1992 version of the GSP on the basis of the re-revision of the "Drug Administration Quality Management Standards", and on April 30, 2000 to the State Drug Administration Decree No. 20 promulgated on July 1, 2000 came into force. The new GSP for pharmaceutical wholesale enterprises and retail enterprises to distinguish between the treatment of more specific, scientific, rich and practical content.
The implementation of the new version of GSP, will be a powerful impetus to the supervision and management of the circulation of drugs in China to move forward steadily, to maintain the normal order of the drug market, standardize business practices, to ensure that the people's medicines are safe and effective will have a positive effect.
Specification for Quality Management of Drug Operation
Chapter I General Principles
Article 1 In order to strengthen the quality management of drug operation, to ensure that the people's medicines are safe and effective, according to the "People's Republic of China *** and the State Drug Administration Law," and other relevant laws and regulations, the formulation of this specification.
Second, the drug business enterprises should be in the purchase of drugs, storage and transportation and sales and other aspects of the implementation of quality management, the establishment of a quality system, including
Organization structure, duties and systems, process management and facilities and equipment, and to make it run effectively.
Article 3 This specification is the basic guidelines for quality management of pharmaceutical business, applicable to the Chinese people **** and the State of the operation of drugs
franchise or part-time enterprises.
Chapter II Quality Management of Wholesale Drugs
Section I Management Responsibilities
Article 4 The main person in charge of the enterprise shall ensure that the enterprise implements the relevant state laws and regulations and these norms, and shall bear the leading responsibility for the quality of the enterprise's operation of medicines
.
Article 5 Enterprises shall establish a quality leadership organization headed by the main person in charge of the enterprise. Its main responsibilities are: the establishment of the enterprise
quality system, the implementation of the enterprise's quality policy, and to ensure that the enterprise's quality management staff to exercise their powers.
Article 6 Enterprises shall set up a specialized quality management organization to exercise quality management functions, and have the right to adjudicate on the quality of medicines within the enterprise
.
Article 7 The enterprise shall set up with the scale of operation of the drug inspection department and acceptance, maintenance and other organizations. Drug inspection
departments and acceptance organizations shall be subordinate to the quality management agencies.
Article 8 Enterprises should be based on relevant laws and regulations and the norms, combined with the actual development of quality management system, and regular
periodic inspection and assessment of the implementation of the system.
Article IX of the enterprise should be regularly on the implementation of this specification for internal review, to ensure the implementation of the specification.
Section II personnel and training
Article 10 The main person in charge of the enterprise should have a professional and technical title, familiar with the state laws, rules and regulations on drug management,
Regulations and knowledge of the drugs operated.
Article 11 The person in charge of the enterprise shall have a professional and technical title of pharmacy, responsible for quality management.
Article XII of the enterprise quality management organization in charge, should be a licensed pharmacist or have the appropriate professional and technical title of pharmacy
Title, and can adhere to the principle of practical experience, and can independently solve the quality of the business process.
Article 13 The person in charge of the drug inspection department shall have the corresponding professional and technical title in pharmacy.
Article XIV of the enterprise engaged in quality management and inspection work, shall have a degree in pharmacy or related professions, or
have a professional and technical title in pharmacy, after professional training and assessment of qualified and licensed.
Article 15 The personnel engaged in receiving and inspection, maintenance, measurement, storage, etc., shall have the appropriate academic qualifications or a certain degree of literacy
chemical degree, after relevant training and assessment of qualified and licensed.
In the country there are employment access provisions of the work of the personnel, need to pass the vocational skills assessment and obtain vocational qualification certificates before
Can be on the job.
Article XVI of the enterprise should be organized annually in direct contact with the medicines of the personnel for health checks, and establish health records. Found
Suffering from mental illness, infectious diseases or other diseases that may contaminate the drugs, patients should be transferred out of direct contact with drugs.
Article XVII of the enterprise shall regularly carry out all types of personnel for drug laws, regulations, rules and professional and technical, pharmaceutical knowledge,
professional ethics and other education or training, and establish a file.
Section III Facilities and Equipment
Article 18 The enterprise shall have a business place and auxiliary, office space appropriate to the scale of operation. Business premises should be bright,
neat and clean.
Article 19 There are warehouses appropriate to the scale of business. Warehouse area ground level, no water and weeds, no source of pollution, and
to:
(a) drug storage operation area, auxiliary operation area, office living area separated by a certain distance or isolation measures, loading and unloading operations
place with a roof.
(2) There are suitable for the classification of drugs for safekeeping and in line with the requirements of drug storage warehouse. The walls, roof and floor of the warehouse are clean and
level, and the doors and windows are tightly structured.
(C) the warehouse area has fire and safety facilities in line with the requirements of the regulations.
Article 20 The warehouse should be divided into a warehouse to be inspected (area), qualified library (area), delivery library (area), non-qualified library (area), return
Goods library (area) and other special places, the operation of Chinese medicine tablets should also be divided into a special library for the zero cargo weighing (area). Above the library (area) should be equipped with a clear
Significant signs.
Article 21 of the warehouse should have the following facilities and equipment:
(a) to maintain a certain distance between the drugs and the ground equipment.
(ii) equipment to avoid light, ventilation and drainage.
(iii) Equipment for detecting and regulating temperature and humidity.
(d) dust, moisture, mold, pollution and insect, rodent, bird and other equipment.
(v) lighting equipment in line with the requirements of safe electricity.
(F) suitable for the demolition and consolidation of the workplace and packaging materials and other storage space and equipment.
Article 22 of the storage of narcotic drugs, a class of psychotropic substances, toxic drugs for medical purposes, radioactive drugs, special warehouses
should have the appropriate safety and security measures.
Article 23 of the scale and scope of business with the appropriate drug testing department, configure the appropriate testing instruments and equipment.
Operation of Chinese herbal medicines and Chinese herbal medicines should be set up specimen room (cabinet).
Article 24 with the size of the enterprise, in line with the health requirements of the acceptance of the maintenance room, equipped with the necessary acceptance and maintenance
Care tools and equipment.
Article 25 of the facilities and equipment used should be regularly inspected, repaired, maintained and established files.
Article 26 The dispensing of traditional Chinese medicine tablets should be in accordance with the provisions of the special place, the area and equipment should be appropriate with the dispensing requirements
Corresponding.
Section IV purchase
Article 27 Enterprises should put the quality of the selection of drugs and supply units in the first place, the development of the purchase of
drugs to ensure that meet the quality requirements of the purchase procedures.
Article 28 The purchased medicines shall meet the following basic conditions:
(1) Medicines produced or operated by legal enterprises.
(2) Having legal quality standards.
(iii) Except for those not stipulated by the state, they should have legal approval numbers and production lot numbers. Imported drugs should be in line with the regulations,
stamped with the original seal of the supplier quality inspection agency, "Imported Drugs Registration Certificate" and "Imported Drugs Inspection Report" copy
piece.
(d) packaging and labeling in accordance with relevant regulations and storage and transportation requirements.
(v) Chinese herbal medicines should be labeled with the place of origin.
Article 29 The enterprise shall conduct an audit of the first enterprise including qualifications and quality assurance capabilities. Audit by the business sector
in conjunction with the quality management organization **** with. In addition to reviewing the relevant information, if necessary, should be a site visit. Approved by the audit, before
from the first enterprise purchase.
Article 30 of the first enterprise varieties (including new specifications, new dosage forms, new packaging, etc.) should be carried out legality and quality of the basic situation
audit, review and approval before operating.
Article 31 The preparation of the purchase plan should be based on the quality of drugs as an important basis, and quality management organizations
to participate.
Article 32 The signing of purchase contracts should be clear quality terms.
Article 33 The purchase of drugs should be legal bills, and in accordance with the provisions of the establishment of purchase records, to achieve the tickets, accounts, goods in line.
Purchase records are kept in accordance with regulations.
Article 34 The enterprise should be purchased every year for quality review.
Section V. Acceptance and Inspection
Article 35 The requirements for the acceptance of the quality of medicines are:
(1) Strictly in accordance with the legal standards and contractual terms of quality of purchased medicines, the quality of the sale of returned medicines batch by batch
acceptance.
(2) Acceptance inspection should be accompanied by a one-by-one inspection
of the packaging, labeling, manuals, and relevant required certificates or documents of the drugs.
(C) acceptance of the samples taken should be representative.
(d) acceptance should be in accordance with the relevant provisions of the acceptance record. Acceptance records should be kept until more than one year beyond the expiration date of the drug, but not
less than three years.
(E) acceptance of the first camp varieties, should also be carried out to test the intrinsic quality of drugs.
(F) acceptance should be carried out in compliance with the provisions of the premises, completed within the specified time limit.
Article 36 The warehouse custodian receives goods with the signature or seal of the inspector. If the goods do not conform to the list, the quality is abnormal, the package is not
fast or broken, the sign is blurred, etc., the right to refuse to accept and report to the relevant departments of the enterprise to deal with.
Article 37 The pharmaceutical inspection department of the enterprise undertakes the task of inspection of the quality of the enterprise's medicines, and provides accurate and reliable
inspection data.
Article 38 of the drug testing department sampling and testing of batches should reach the total number of batches of the specified proportion of incoming goods.
Article 39 The main contents of the management of the acceptance and inspection of drug quality are:
(1) The collection, distribution and storage of drug quality standards and related regulations.
(2) Principles and procedures of sampling, operational procedures for acceptance and inspection.
(3) The treatment of drugs found to be problematic.
(iv) Regular calibration and verification of instruments and equipment, measuring tools, use, maintenance and registration of instruments.
(v) The establishment, collection, filing and storage of original records and drug quality files.
(VI) Collection and storage of Chinese medicine specimens.
Article 40 Enterprises shall carry out controlled management of quality unqualified drugs, and its management focuses on:
(1) Unqualified drugs shall be found to be reported in accordance with the stipulated requirements and procedures.
(ii) The labeling and storage of unqualified drugs.
(iii) identify the causes of unqualified quality, distinguish the quality responsibility, timely treatment and develop preventive measures.
(d) unqualified drugs scrapped, destroyed records.
(E) unqualified drugs processing summary and analysis.
Section VI Storage and Maintenance
Article 41 The medicines shall be stored in special storage and categorized according to the specified storage requirements. The following points shall be observed in storage:
(1) Medicines shall be stored in the appropriate library according to the requirements of temperature and humidity.
(ii) in the storage of drugs should be color-coded management.
(c) handling and stacking should strictly comply with the requirements of the drug packaging pattern marking, standardized operation. Fear of pressure drugs should be controlled stacking
Placing height, regular stacking.
(d) drugs and warehouse floor, wall, roof, radiator should be appropriate spacing or isolation measures.
(e) The drugs should be stacked centrally according to the batch number. Effective date of the drugs should be categorized relatively centralized storage, according to the lot number and the validity of the near and distant
Subsequent or separate stacking and have a clear sign.
(F) drugs and non-drugs, internal and external medicines, prescription drugs and non-prescription drugs should be stored separately; easy to cascade of drugs
products, Chinese herbal medicines, traditional Chinese medicine, as well as dangerous goods should be stored separately from other drugs.
(VII) narcotic drugs, a class of psychotropic drugs, toxic drugs for medical use, radioactive drugs should be stored in special libraries or special cabinets, double
double-locked custody, special account records.
Article 42 The main duties of the conservation of drugs are:
(1) To guide the custodian of the drugs for reasonable storage.
(2) To check the storage conditions of the medicines in storage, and to cooperate with the custodians in the management of temperature and humidity in the warehouse.
(iii) Conducting regular quality inspections of drugs in stock and making inspection records.
(d) The Chinese herbal medicines and Chinese herbal medicinal tablets are maintained by drying, oxygen reduction, fumigation and other methods according to their characteristics.
(e) For medicines that may have quality problems due to abnormal reasons and Chinese herbal medicines that have been in storage for a long time, samples should be sent for inspection.
(vi) The problems found during the inspection shall be promptly notified to the quality management organization for review and processing.
(vii) Regularly summarize, analyze and report quality information such as maintenance inspection, near expiration date or long time storage of medicines.
(viii) is responsible for the maintenance of instruments and equipment, temperature and humidity detection and monitoring instruments, warehouse in use measuring instruments and apparatus, etc.
Work.
(ix) the establishment of drug maintenance files.
Section VII out of the warehouse and transportation
Article 43 of the drugs out of the warehouse should follow the "first production first out", "recent first out" and according to the principle of batch number delivery.
Article 44 The drugs shall be reviewed and quality checked. Narcotic drugs, a class of psychotropic drugs, medical toxicity
Drugs shall establish a two-person verification system.
Article 45 Drugs out of the warehouse shall make a good record of the quality tracking of drugs to ensure that the quality tracking can be carried out quickly and accurately.
The records shall be kept until one year beyond the expiration date of the drugs, but not less than three years.
Article 46 The transportation of medicines with temperature requirements shall take necessary measures of heat preservation
or refrigeration according to the seasonal temperature changes and transportation.
Article 47 The transportation of narcotic drugs, Class I psychotropic drugs, toxic drugs for medical use and dangerous goods shall be handled in accordance with the relevant provisions
.
Article 48 When drugs are directly transferred from the production enterprises, they shall be shipped only after the quality inspection and acceptance of the operating units.
Article 49 The handling, loading and unloading of drugs should be gently, strictly in accordance with the requirements of the outer packaging labeling requirements stacking and preventive
protection measures.
Section VIII Sales and After-sales Service
Article 50 Enterprises shall sell medicines to legally qualified units in accordance with relevant laws, regulations and rules.
Article 51 The sale of specially managed drugs shall be carried out in strict accordance with the relevant state regulations.
Article 52 The sales personnel shall correctly introduce the medicines and shall not falsely exaggerate and mislead the users.
Article 53 Sales shall issue legal bills and establish sales records in accordance with the regulations, so that the bills, accounts and goods are consistent. Sales
Tickets and records shall be kept in accordance with the provisions.
Article 54 The enterprise shall ensure the quality of the medicines directly transferred from other commercial enterprises for special needs, and shall promptly
make relevant records.
Article 55 The marketing and publicity of medicines shall strictly implement the state laws and regulations on advertising management, and the contents of the publicity must
be based on the instruction manuals of the medicines approved by the State Drug Administration and Supervision Department.
Article 56 The causes of quality inquiries, complaints, sampling and quality problems found in the course of sales shall be identified, the responsibility shall be assigned
and effective measures shall be taken to deal with them, and records shall be kept.
Article 57 The enterprise has been sold drugs such as quality problems found, should be reported to the relevant management department, and timely recovery of
drugs and make a good record.
Chapter III Quality Management of Drug Retailing
Section I Management Responsibilities
Article 58 Drug retailing and retail chain enterprises shall engage in business
activities in compliance with the legally-approved mode and scope of operation, and shall prominently display in the business hall of the business of the drug business enterprise licenses, business licenses, and with the requirements of the licensed personnel.
Compatible with the license certificate.
Article 59 The principal person in charge of an enterprise shall be responsible for the quality of the drugs operated by the enterprise.
Article 60 Enterprises shall set up quality management organizations or full-time quality management personnel, specifically responsible for enterprise quality management
work.
Article 61 Enterprises shall, in accordance with relevant state laws, regulations and this specification, and combined with the actual enterprise, the development of various quality
quality management system. The management system shall be regularly inspected and assessed, and records shall be established.
Section II personnel and training
Article 62 The person in charge of quality of the enterprise shall have a technical title in pharmacy.
Article 63 The prescription reviewer in the retail of drugs shall be a licensed pharmacist or have a pharmacist or above (including pharmacists and Chinese pharmacists)
professional technical title.
Article 64 The quality management and drug inspection personnel of an enterprise shall have a degree in pharmacy or a related specialty, or have a
technical title in pharmacy.
Article 65 The personnel of an enterprise engaged in quality management, inspection, acceptance, storage, maintenance and business shall undergo
professional training, and be licensed to work after passing the examination. The state has employment access provisions of the post, the staff need to pass the vocational skills identification
and obtain professional qualification certificate before taking up their duties.
Article 66 Enterprises should be organized annually to direct contact with the medicines of the personnel for health checks, and establish health records. Found
now suffering from mental illness, infectious diseases and other diseases that may contaminate the drugs, should be promptly transferred from their jobs.
Section III facilities and equipment
Article 67 of the retail drug enterprises should be compatible with the scale of business premises and drug warehouses, and the environment is neat and
clean, free of pollutants. The business premises, warehouses, offices and living areas shall be separated.
Article 68 The business premises and drug warehouses of drug retail enterprises shall be equipped with the following equipment:
(a) equipment for the display of drugs.
(2) The storage equipment for special management of drugs.
(C) room temperature, cool and refrigerated storage equipment in line with the requirements of the characteristics of drugs.
(D) the necessary drug testing, acceptance, maintenance equipment.
(e) test and adjust the temperature and humidity of the equipment.
(vi) Equipment to maintain a certain distance between the drugs and the ground.
(vii) drug dust, moisture, pollution and insect, rodent, mildew and other equipment.
(viii) the business of traditional Chinese medicine tablets required for the dispensing of prescriptions and clinical prescription concoctions of equipment.
Article 69 of the retail chain of pharmaceutical enterprises shall set up distribution centers compatible with the scale of operation, warehousing, acceptance,
inspection, maintenance and other facilities required to be the same as the same size of the wholesale enterprises. Retail chain stores of drug display, storage and other equipment requirements
Requirements should be the same as retail enterprises.
Section IV purchase and acceptance
Article 70 Enterprises purchasing drugs should be based on the premise of quality, from legitimate enterprises. The first enterprise shall confirm its legal
legal qualifications and keep records.
Article 71 The purchase of medicines shall be supported by legal bills, and purchase records shall be established in accordance with the regulations, so as to ensure that the bills, accounts and goods are consistent.
Purchase tickets and records should be kept until more than one year beyond the expiration date of drugs, but not less than two years.
Article 72 The contract for the purchase of drugs shall specify the quality terms.
Article 73 The purchase of the first varieties, should be carried out to audit the quality of drugs, the audit is qualified before operating.
Article 74 The acceptance personnel of the purchased drugs, should be based on the original documents, in strict accordance with the relevant provisions of the batch-by-batch acceptance and
record. If necessary, samples shall be sent to the inspection agency for inspection.
Article 75 When accepting the quality of drugs, should be in accordance with the provisions of the simultaneous inspection of packaging, labeling, instructions and other items.
Section V. Display and Storage
Article 76 The quality and packaging of drugs displayed in retail stores shall comply with the provisions.
Article 77 Drugs shall be displayed and stored according to the dosage form or use and storage requirements:
(1) Drugs and non-drugs, drugs for internal use and drugs for external use shall be stored separately, and drugs susceptible to crosstalk and general drugs shall be stored separately.
(ii) Medicines should be stored according to their temperature and humidity requirements and in accordance with the specified storage conditions.
(c) Prescription drugs and non-prescription drugs should be placed in separate cabinets.
(d) Special management of drugs should be stored in accordance with the relevant provisions of the state.
(e) Dangerous goods should not be displayed. If they must be displayed because of necessity, only substitutes or empty packages should be displayed. Storage of dangerous goods
Should be managed and stored in accordance with the relevant state regulations.
(f) The unpacked drugs should be centrally stored in the special cabinet for unpacking and retain the label of the original package.
(vii) The quality of Chinese herbal medicines should be checked before loading the hopper, and the wrong hopper or string of hoppers should not be allowed to prevent mixing of medicines. Drinking tablets should be written before the bucket positive name positive
word.
Article 78 The maintenance of displayed and stored medicines includes:
(1) Regularly checking the quality of displayed and stored medicines and keeping records. Drugs with near expiration date, drugs prone to mold and mildew, and drugs prone to moisture dissolution shall have their inspection cycles shortened depending on the circumstances, and samples of drugs with doubtful quality and those stored for a long time shall be promptly sampled and sent for inspection.
(ii) check whether the environment and storage conditions for display of drugs meet the specified requirements.
(c) Checking of all kinds of maintenance equipment.
(iv) Problems found during the inspection should be reported to the person in charge of quality and dealt with as soon as possible.
Article 79 Stock of medicines shall be color-coded management.
Section VI Sales and Service
Article 80 The sale of medicines shall strictly abide by the relevant laws, regulations and systems, and correctly introduce the performance, use,
contraindications and precautions of the medicines.
Article 81 of the sale of drugs, prescriptions should be licensed pharmacists or pharmacists with the title of
personnel above the pharmacist (including pharmacists and Chinese pharmacists) review and approval before dispensing and sales. The drugs listed in the prescription shall not be changed without authorization or substitution. There are contraindications or overdose
of the prescription, should be refused to deploy, sales, if necessary, need to be corrected by the original prescription doctor or re-signature can be deployed and sales.
Auditing, blending or sales staff should be signed or stamped on the prescription, prescription in accordance with the relevant provisions of the prescriptions saved for inspection.
Article 82 The tools and bags used for the sale of medicines should be clean and hygienic, and the name, specification, method of service, dosage and expiration date of the medicines should be written on the bags when they are sold.
The name of the medicines, specification, method of service, dosage and expiration date of the medicines are written on the bags when they are sold.
Article 83 The sale of specially administered drugs shall be in strict accordance with the relevant provisions of the State, with the official seal of the medical unit stamped
doctor's prescription for a limited supply of sales and review personnel shall sign or stamp on the prescription, the prescription is kept for two years.
Article 84 Enterprises shall provide counseling services in the retail premises to guide customers in the safe and rational use of drugs. Enterprises should also
Set up a comment book and publish a monitoring telephone number, customer criticism or complaints should be resolved in a timely manner.
Chapter IV Supplementary Provisions
Article 85 The meanings of the following terms in this specification are:
Principal person in charge of the enterprise: enterprises with legal personality refers to its legal representative; enterprises without legal personality refers to its most
higher managers.
First enterprise: the pharmaceutical production or operation enterprise with which the supply and demand relationship first occurs at the time of purchasing drugs.
The first species: the enterprise to a drug manufacturer for the first time the purchase of drugs.
Drugs direct transfer: drugs that have been purchased but not yet in storage are sent directly from the supplier to the demander
requirer who purchases the same drug from the enterprise.
Prescription Dispensing: the process of selling medicines whereby the salesperson dispenses and matches the medicines according to the doctor's prescription.
Article 86 of the State Drug Administration in accordance with this specification to formulate implementation rules.
Article 87 The State Drug Administration is responsible for the interpretation of this specification.
Article 88 This specification since July 1, 2000 shall come into force.