What does GSP mean?

"Good Quality Management Practice for Pharmaceutical Trading"

GSP is the abbreviation of English Good Supplying Practice, which is literally translated into good drug supply specification, and is called "Good Quality Management Specification for Pharmaceutical Trading" in China. It refers to a management system formulated in the process of drug circulation to ensure that drugs meet the quality standards of planned procurement, procurement acceptance, storage, sales and after-sales service. Its core is to control the behavior of enterprises through strict management system, control the quality of the whole process of drug management, and ensure the provision of high-quality drugs to users.

In 1982, China started the drafting of the GSP. After more than two years' efforts, the "Quality Management Standard for Pharmaceutical Commodities (Trial)" formulated by China Pharmaceutical Company in 1984 was issued by the former State Administration of Medicine and tried out in the national pharmaceutical business scope. The release and implementation of the first set of GSP in China has aroused widespread concern of pharmaceutical commercial enterprises, and many enterprises have gradually brought GSP into the development track of enterprises, making it an important part of enterprise management. After several years of trial, in 199 1, china association of pharmaceutical commerce organized forces to revise the 1984 version of GSP, which was formally promulgated and implemented by the former State Administration of Medicine in 1992, making GSP a departmental regulation for the government to manage the pharmaceutical industry.

1998 after the establishment of the state administration of pharmaceutical products, the experience of implementing GSP for more than ten years was summarized. On the basis of GSP 1992, the Quality Management Standard for Pharmaceutical Trading was revised again, which was promulgated by National Pharmaceutical Product Management Order No.20 on April 30, 2000 and officially implemented on July 1 2000. The new GSP treats pharmaceutical wholesale enterprises and retail enterprises differently, and its content is more specific, scientific, rich and practical.

The implementation of the new GSP will surely promote the steady development of drug circulation supervision and management in China, and play a positive role in maintaining the normal order of the drug market, standardizing the business behavior of enterprises and ensuring the safety of people's drug use.

Good supply practice

Chapter I General Principles

Article 1 In order to strengthen the quality management of pharmaceutical business and ensure the safety and effectiveness of people's drug use, this Specification is formulated in accordance with the Drug Administration Law of People's Republic of China (PRC) and other relevant laws and regulations.

Article 2 Pharmaceutical trading enterprises shall carry out quality control over the procurement, storage, transportation and sales of pharmaceuticals, and establish a quality management team.

Organizational structure, responsibility system, process management and quality system of facilities and equipment, and make them run effectively.

Article 3 This Code is the basic guideline for the quality management of pharmaceutical trading, which is applicable to pharmaceutical trading in People's Republic of China (PRC) and China.

Franchise or part-time enterprise.

Chapter II Quality Management of Drug Wholesale

The first section management responsibilities

Article 4 The principal responsible person of an enterprise shall ensure that the enterprise implements the relevant state laws, regulations and this Code, and deals in drugs for the enterprise.

Take leadership responsibility for product quality.

Article 5 An enterprise shall establish a quality leading organization headed by the principal responsible person of the enterprise. Its main duties are: to start a business.

Quality system, implement the enterprise quality policy, and ensure that the enterprise quality management personnel exercise their functions and powers.

Article 6 An enterprise shall set up a special quality management organization to exercise its quality management functions and control the quality of drugs within the enterprise.

Have the power of adjudication.

Article 7 An enterprise shall set up a drug inspection department and organizations such as acceptance and maintenance that are suitable for its business scale. drug screening

Departments and acceptance agencies should be subordinate to quality management agencies.

Eighth enterprises should be based on relevant laws and regulations and this specification, combined with the actual situation of enterprises to develop quality management system, and set up.

Implement a regular inspection and evaluation system.

Article 9 Enterprises shall regularly conduct internal review on the implementation of these Standards to ensure the implementation of these Standards.

Section 2 Personnel and Training

Article 10 The principal person in charge of an enterprise shall have a professional title and be familiar with the national laws and regulations on drug administration.

Understand the regulations and drugs handled.

Article 11 Among the persons in charge of an enterprise, there should be persons with professional and technical titles in pharmacy who are responsible for quality management.

Article 12 The person in charge of the quality management institution of an enterprise shall be a licensed pharmacist or have corresponding professional and technical positions in pharmacy.

Said, and can adhere to the principle, have practical experience, can independently solve the quality problems in the process of operation.

Article 13 The person in charge of the drug inspection department shall have the corresponding professional and technical title of pharmacy.

Fourteenth enterprises engaged in quality management and inspection personnel, should have a pharmacy or related professional education, or

Have the professional title of pharmacy, and hold the post with certificates after professional training and examination.

Fifteenth personnel engaged in inspection, maintenance, measurement, storage and other work, should have the corresponding academic qualifications or a certain degree.

Education, after passing the relevant training and examination, show certificates.

Personnel who work in posts with national employment access regulations must pass vocational skill appraisal and obtain vocational qualification certificates.

Can be employed.

Article 16 An enterprise shall organize the personnel who have direct contact with drugs to have health check-ups every year and establish health records. find

Patients suffering from mental illness, infectious diseases or other diseases that may pollute drugs shall be transferred from their posts where they are in direct contact with drugs.

Seventeenth enterprises should regularly carry out drug laws, regulations, rules and professional technology, drug knowledge,

Professional ethics education or training, and establish files.

Section 3 Facilities and Equipment

Article 18 An enterprise shall have a business place and auxiliary and office premises suitable for its business scale. Business premises should be bright,

Clean and tidy.

Article 19 There shall be warehouses suitable for the scale of operation. The ground in the reservoir area is flat, without water, weeds and pollution sources.

Do:

(a) drug storage work area, auxiliary work area, office and living area are separated by a certain distance or have isolation measures, and loading and unloading operations are carried out.

This place has a roof.

(2) Having warehouses suitable for classified drug storage and meeting the requirements for drug storage. The walls, ceilings and floors of the warehouse are bright and clean.

Flat and tight door and window structure.

(three) the reservoir area has fire control and safety facilities that meet the prescribed requirements.

Article 20 The warehouses shall be divided into warehouses (areas) to be inspected, qualified warehouses (areas), delivery warehouses (areas), unqualified warehouses (areas) and returned warehouses.

Special places such as warehouses (districts) should also be divided into special warehouses (districts) for the operation of Chinese herbal pieces. The above libraries (districts) should be equipped with.

Show signs.

Article 21 A warehouse shall have the following facilities and equipment:

(1) Equipment for keeping medicines at a certain distance from the ground.

(2) Light-proof, ventilation and drainage equipment.

(3) Equipment for detecting and adjusting temperature and humidity.

(four) dust-proof, moisture-proof, mildew-proof, pollution-proof, insect-proof, rat-proof, bird-proof and other equipment.

(five) lighting equipment that meets the requirements of safe electricity use.

(six) there are workplaces suitable for unpacking and places and equipment for LCL to transport and store packaging materials.

Article 22 Special warehouses for storing narcotic drugs, psychotropic drugs of Category I, toxic drugs for medical use and radioactive drugs.

There should be corresponding safety measures.

Article 23 A drug inspection department shall be set up in accordance with its business scale and scope, equipped with corresponding inspection instruments and equipment.

Chinese herbal medicines and Chinese herbal pieces should be provided with Chinese herbal medicine specimen room (cabinet).

Article 24 There shall be an inspection and maintenance room suitable for the scale of the enterprise and meeting the hygiene requirements, equipped with necessary inspection and maintenance personnel.

Protective tools, instruments and equipment.

Twenty-fifth facilities and equipment used should be regularly inspected, repaired and maintained, and files should be established.

Twenty-sixth packaging Chinese herbal pieces should have a special place that meets the requirements, and its area and equipment should be adapted to the packaging requirements.

Yes

The fourth quarter purchase

Article 27 When selecting drugs and suppliers, enterprises should give priority to quality, and formulate conditions to ensure procurement.

Procurement procedures for drugs that meet quality requirements.

Article 28 The procurement of drugs shall meet the following basic conditions:

(1) Drugs produced or handled by legal enterprises.

(2) Having legal quality standards.

(3) Unless otherwise stipulated by the state, there should be a legal approval number and a production batch number. Imported drugs should meet the requirements,

A copy of the registration certificate of imported drugs and a copy of the inspection report of imported drugs stamped with the original seal of the supplier's quality inspection agency.

Fragments.

(4) The packaging and signs comply with relevant regulations and storage and transportation requirements.

(five) Chinese herbal medicines should indicate the origin.

Twenty-ninth enterprises should audit the initial enterprises, including qualification and quality assurance ability. Business department audit

In conjunction with the quality management organization * * *. In addition to reviewing relevant information, field visits should be conducted when necessary. After examination and approval, the party may

Purchase goods from a battalion of enterprises.

Thirtieth enterprises should have a basic understanding of the legitimacy and quality of the first varieties (including new specifications, new dosage forms, new packaging, etc.). )

Conditions for review, review qualified rear can operate.

Article 31 When making a procurement plan, an enterprise shall take the quality of drugs as an important basis and have quality management personnel.

Attend.

Article 32 When signing a procurement contract, the quality terms shall be clearly defined.

Article 33 When purchasing drugs, there should be legal bills, and purchase records should be established according to regulations, so that the tickets, accounts and goods are consistent.

Procurement records shall be kept as required.

Article 34 An enterprise shall review the quality of its procurement every year.

Section 5 Acceptance and Inspection

Article 35 The requirements for drug quality acceptance are:

(a) in strict accordance with the statutory standards and the quality provisions of the contract, the quality inspection of the purchased drugs and the drugs returned after sale.

Batch acceptance.

(2) At the same time, the packages, labels, instructions and relevant certificates or documents of drugs should be inspected one by one.

Check.

(three) the samples taken for acceptance shall be representative.

(four) the acceptance shall be recorded in accordance with the relevant provisions. The acceptance records shall be kept for more than one year after the expiry date of the drug, but shall not be

Less than three years.

(five) when the first variety is accepted, the internal quality of the drug should also be tested.

(six) the acceptance shall be carried out in a place that meets the requirements and completed within the prescribed time limit.

Article 36 The warehouse keeper shall receive the goods signed or sealed by the inspector. Inconsistent bill, abnormal quality and poor packaging

Fast or broken, fuzzy signs, etc. , have the right to refuse and report to the relevant departments of the enterprise for processing.

Article 37 The drug inspection department of an enterprise undertakes the inspection of the drug quality of the enterprise and provides accurate and reliable drug quality information.

Test data.

Article 38 The number of sampling inspection lots by the drug inspection department shall reach the specified proportion of the total purchase batches.

Article 39 The main contents of drug quality acceptance and inspection management are:

(1) Collection, distribution and storage of drug quality standards and related regulations.

Sampling principles and procedures, acceptance and inspection procedures.

How to deal with the drugs that are found to have problems.

(4) Regular calibration and verification of instruments, equipment and measuring tools, use, maintenance and registration of instruments, etc.

(five) the establishment, collection, filing and storage of original records and drug quality files.

(6) Collection and preservation of traditional Chinese medicine specimens.

Article 40 An enterprise shall control the management of substandard drugs, with emphasis on:

(a) found unqualified drugs should be reported according to the prescribed requirements and procedures.

(2) Identification and storage of unqualified drugs.

(three) to find out the reasons for the unqualified quality, to distinguish the quality responsibility, and to deal with and formulate preventive measures in a timely manner.

(4) Records of scrapping and destroying unqualified drugs.

(five) summary and analysis of the treatment of unqualified drugs.

Section 6 Storage and Maintenance

Article 41 Drugs shall be stored in special warehouses and classified according to the specified storage requirements. The following points shall be observed during storage:

(a) drugs are stored in the corresponding warehouse according to the requirements of temperature and humidity.

(two) in the library of drugs should be color management.

(three) handling and stacking should strictly abide by the requirements of the schematic signs of drug packaging and standardize the operation. Drugs that fear stress should be controlled.

Put the height well and turn the pile regularly.

(four) there should be corresponding spacing or isolation measures between drugs and the ground, walls, roof and radiator of the warehouse.

(five) drugs should be stacked in batches. The validity period of drugs should be classified and stored according to the batch number and validity period.

The stacking time shall be clearly marked separately.

(six) drugs and non-drugs, oral drugs and external drugs, prescription drugs and over-the-counter drugs should be stored separately; An odorous drug.

Commodities, Chinese herbal medicines, Chinese herbal pieces and dangerous goods should be stored separately from other medicines.

(seven) narcotic drugs, psychotropic drugs, toxic drugs for medical use and radioactive drugs should be stored in special warehouses or counters.

Double lock custody, special account records.

Article 42 The main duties of drug maintenance work are:

(a) to guide the safekeeping personnel to store drugs reasonably.

(two) check the storage conditions of drugs in the warehouse, and cooperate with the storage personnel to manage the temperature and humidity between warehouses.

(three) regular quality inspection of drugs in stock, and make inspection records.

(four) Chinese herbal medicines and Chinese herbal pieces should be processed by drying, oxygen reduction and fumigation according to their characteristics.

(five) drugs that may have quality problems due to abnormal reasons and Chinese herbal medicines that have been stored for a long time shall be sampled and tested.

(six) timely notify the quality management agencies to review the problems found in the inspection.

(seven) regularly summarize, analyze and report the quality information of drugs such as maintenance inspection, short-term or long-term storage.

(eight) responsible for the maintenance of equipment, temperature and humidity detection and monitoring instruments, measuring instruments and appliances in use in the warehouse management.

Work.

(nine) the establishment of drug maintenance files.

Section 7 outbound and transportation

Article 43 The principle of "first in, first out", "first out in the near future" and delivery by batch shall be followed.

Forty-fourth drugs should be checked out of the library. Narcotic drugs, a class of psychotropic drugs, medical toxicity

Drugs should be examined by two people.

Forty-fifth drugs should be tracked after leaving the library to ensure that the quality can be tracked quickly and accurately.

Records shall be kept for more than one year, but not less than three years.

Article 46 When transporting drugs with temperature requirements, necessary heat preservation measures shall be taken according to seasonal temperature changes and transportation distance.

Or refrigeration measures.

Article 47 Narcotic drugs, psychotropic drugs, toxic drugs for medical use and dangerous goods shall be transported in accordance with relevant regulations.

Handle.

Forty-eighth drugs are directly mixed by the production enterprises, and can only be delivered after the quality acceptance of the business units.

Forty-ninth handling, loading and unloading of drugs should be handled with care, strictly in accordance with the requirements of graphic signs on the outer packaging and take preventive measures.

Protective measures.

Section 8 Sales and after-sales service

Article 50 An enterprise shall sell drugs to legally qualified units in accordance with the provisions of relevant laws, regulations and rules.

Article 51 The sale of specially managed drugs shall be strictly in accordance with the relevant provisions of the state.

Article 52 Sales personnel shall introduce drugs correctly, and shall not falsely exaggerate or mislead users.

Fifty-third sales should issue legal bills, and establish sales records according to regulations, so that tickets, accounts and goods are consistent. sell

Tickets and records shall be kept as required.

Article 54 For drugs directly transferred from other commercial enterprises due to special needs, the enterprise shall ensure the quality of the drugs and supply them in time.

Make relevant records.

Fifty-fifth drug marketing publicity should strictly implement the national laws and regulations on advertising management, and the publicity content must be

The instructions for drug use approved by the state drug supervision and administration department shall prevail.

Fifty-sixth quality problems found in the process of quality inquiry, complaint, spot check and sales should find out the reasons and distinguish them.

Responsibility, take effective measures, and make records.

Article 57 If there are quality problems with the drugs sold by enterprises, they should report to the relevant administrative departments and recover them in time.

Drugs and make records.

Chapter III Drug Retail Quality Management

The first section management responsibilities

Article 58 Pharmaceutical retail and retail chain enterprises shall operate in accordance with the business mode and business scope approved according to law.

During the activity, the license, business license and employee requirements of pharmaceutical trading enterprises should be hung in a prominent position in the business store.

Operator's practice certificate.

Article 59 The principal responsible person of an enterprise shall take the leadership responsibility for the quality of drugs handled by the enterprise.

Article 60 An enterprise shall set up a quality management organization or be equipped with full-time quality management personnel to be specifically responsible for the quality management of the enterprise.

Work.

Article 61 An enterprise shall formulate various quality standards in accordance with relevant national laws and regulations and these Standards, and in combination with the actual situation of the enterprise.

Quantity management system. The management system shall be inspected and evaluated regularly, and records shall be established.

Section 2 Personnel and Training

Article 62 The person in charge of enterprise quality shall have the title of pharmaceutical technology.

Article 63 Prescription examiners in drug retailing shall be licensed pharmacists or above (including pharmacists and Chinese pharmacists).

Professional and technical titles.

Article 64 The quality management personnel and drug inspectors of an enterprise shall have a degree in pharmacy or related majors or have

Professional and technical titles of pharmacy.

Sixty-fifth enterprises engaged in quality management, inspection, acceptance, storage, maintenance, business and other work personnel should go through

Professional training, show certificates after passing the examination. For positions with national employment access regulations, staff members need to pass vocational skills certification.

Set up and obtain professional qualification certificate before taking up the post.

Article 66 An enterprise shall organize personnel who have direct contact with drugs to have health check-ups every year, and establish health records. hair

Persons suffering from mental illness, infectious diseases and other diseases that may pollute drugs shall be transferred from their posts in time.

Section 3 Facilities and Equipment

Article 67 A pharmaceutical retail enterprise shall have a business place and a pharmaceutical warehouse suitable for its business scale, and the environment shall be clean and tidy.

Clean, no pollutants. The business premises, warehouses, office life and other areas of an enterprise should be separated.

Article 68 The business premises and drug warehouses of pharmaceutical retail enterprises shall be equipped with the following equipment:

(1) Equipment convenient for displaying drugs.

(2) storage equipment for specially managed drugs.

(3) Normal-temperature, light-proof and cold-storage equipment that meets the requirements of drug characteristics.

(4) Necessary equipment for drug inspection, acceptance and maintenance.

(5) Temperature and humidity testing and adjusting equipment.

(six) keep a certain distance between drugs and the ground.

(7) Dust-proof, moisture-proof, anti-fouling, insect-proof, rat-proof and mildew-proof equipment.

(eight) prescription preparation and processing equipment required for the operation of Chinese herbal pieces.

Article 69 A pharmaceutical retail chain enterprise shall set up a distribution center suitable for its business scale, and conduct the storage, acceptance,

The requirements for inspection and maintenance facilities are the same as those for wholesale enterprises of the same scale. Equipment such as drug display and storage in retail chain stores should be

The demand is the same as that of retail enterprises.

Section 4 Procurement and Acceptance

Article 70 An enterprise shall purchase drugs from legal enterprises on the premise of ensuring quality. The first business enterprise should be confirmed.

Lawyer qualification, and make records.

Seventy-first drugs should be purchased with legal bills, and purchase records should be established according to regulations, so that the tickets, accounts and goods are consistent.

Procurement bills and records shall be kept for more than one year, but not less than two years.

Article 72 A drug purchase contract shall contain quality clauses.

Seventy-third varieties purchased for the first time should be audited for drug quality, and they can only be operated after passing the examination.

Article 74 Inspectors shall, according to the original documents and in strict accordance with the relevant regulations, accept the purchased drugs in batches.

Record. If necessary, the samples should be sent to the inspection agency for inspection.

Article 75 When accepting the quality of drugs, the package, labels, instructions and other contents shall be checked at the same time as required.

Section 5 Display and Storage

Article 76 The quality and packaging of drugs displayed in retail stores shall conform to the provisions.

Article 77 Drugs shall be displayed and stored according to their dosage forms, uses and storage requirements:

(a) drugs and non-drugs, drugs for internal use and drugs for external use should be stored separately, and drugs that are easy to smell should be stored separately from general drugs.

(two) drugs should be stored according to their temperature and humidity requirements and in accordance with the prescribed storage conditions.

(three) prescription drugs and over-the-counter drugs should be placed in separate cabinets.

(four) special management of drugs should be stored in accordance with the relevant provisions of the state.

(5) Dangerous goods should not be displayed. If necessary, only substitutes or empty packages can be displayed. Storage of dangerous goods

Management and storage should be carried out in accordance with the relevant provisions of the state.

(six) drugs should be stored in the counter, and keep the original packaging label.

(seven) the quality of Chinese herbal pieces should be checked before loading, and no wrong fighting or string fighting is allowed to prevent mixed loading. Correct the name before the bucket of pieces.

Words.

Article 78 The maintenance of drug display and storage includes:

(1) Regularly check and record the quality of drugs displayed and stored. Drugs with short-term effects, drugs prone to mildew and deliquescence are regarded as

The inspection cycle is shortened, and drugs with questionable quality and long storage time should be sampled and inspected in time.

(two) to check whether the drug display environment and storage conditions meet the requirements.

(3) check all kinds of maintenance equipment.

(four) the problems found in the inspection should be reported to the quality director in time and dealt with as soon as possible.

Article 79 Stored drugs shall be subject to color code management.

Section 6 Sales and Services

Article 80 When selling drugs, we must strictly abide by the relevant laws, regulations and systems, and correctly introduce the performance, use,

Taboos and precautions.

Article 81 When selling drugs, prescriptions must be approved by licensed pharmacists or personnel with the title of pharmacist or above (including pharmacists and Chinese pharmacists).

Only after personnel review can it be deployed and sold. The drugs listed in the prescription shall not be changed or replaced without authorization. Compatibility contraindication or overdose

After the prescription is issued, it should be refused to be deployed and sold, and it can be deployed and sold only after it is corrected or re-signed by the original prescriber when necessary.

Audit, deployment or sales personnel should sign or seal the prescription and keep it for future reference according to relevant regulations.

Article 82 The tools and packaging bags used for selling drugs shall be clean and hygienic, and shall be marked on the packaging bags of drugs when selling.

Name, specification, dosage, expiration date, etc.

Article 83 The sale of specially managed drugs shall be strictly in accordance with the relevant provisions of the State and stamped with the official seal of the medical unit.

Doctors' prescriptions are supplied in limited quantities, signed or sealed by sales and review personnel, and the prescriptions are kept for two years.

Article 84 An enterprise shall provide consulting services in retail places to guide customers to use drugs safely and rationally. Enterprises should also

Set up a suggestion book and publish the supervision telephone number to solve the customer's criticism or complaint in time.

Chapter IV Supplementary Provisions

Article 85 The meanings of the following terms in this Law are:

Principal person in charge of an enterprise: an enterprise legal person refers to its legal representative; An unincorporated enterprise refers to its most

Senior manager.

First-run enterprise: a pharmaceutical production or management enterprise that has the first supply-demand relationship with the enterprise when purchasing drugs.

The first variety: drugs purchased by this enterprise from pharmaceutical manufacturers for the first time.

Direct allocation of drugs: drugs that have been purchased but not put into storage are directly sent from suppliers to the buyers of the same drugs in the enterprise.

Find the profile.

Prescription allocation: when selling drugs, business personnel adjust and cooperate with drugs according to doctors' prescriptions.

Article 86 The State Pharmaceutical Products Supervision and Administration Bureau shall formulate detailed rules for implementation in accordance with this Code.

Article 87 The State Administration of Pharmaceutical Products shall be responsible for the interpretation of this Code.

Article 88 This Law shall come into force as of July 6, 2000.