What Are Blood Products?

Blood products refer to various human plasma protein products, including human albumin, human placental albumin, human immunoglobulin for intravenous injection, human immunoglobulin, histamine human immunoglobulin, specific immunoglobulin, Immunoglobulins (hepatitis B, rabies, tetanus immunoglobulins), human factor , human thrombin complex, human fibrinogen, anti-human lymphocyte immunoglobulin, etc. The raw material for blood products is plasma. 92%-93% of human plasma is water and only 7%-8% is protein. Blood products are made by separating and purifying this protein.

Chinese name: Blood products
Meaning: Various human plasma protein products

Including: Human albumin, human placental albumin
Raw materials: plasma

Introduction to blood products

Blood products belong to the scope of biological products, which mainly refer to biologically active preparations prepared from biological blood or separation and purification technology using healthy human blood as raw materials. Since the development of blood products, products that have been included in the 2000 version of the "Chinese Biological Product Regulations" include intravenous immunoglobulin, specific immunoglobulin, histamine human immunoglobulin, human factor , and human prothrombin , Intramuscular injection of human immunoglobulin, anti-human lymphocyte immunoglobulin, rabies patient albumin, tetanus immunoglobulin, human fibrinogen, hepatitis B, human placental blood albumin. Products currently undergoing clinical research include lyophilized human thrombin, antithrombin-III, lyophilized human fibrin adhesive for external use, and the like.

Raw materials for blood products

The raw material of blood products is plasma. 92%-93% of human plasma is water, and only 7%-8% is protein. Blood products are made by separating and purifying these proteins. Due to technical limitations, only a portion of plasma proteins can be used. Albumin is the most abundant macromolecular protein in human blood and can be produced by all blood product companies. Albumin has a variety of physiological functions, including increasing circulating blood volume and colloid osmotic pressure necessary to maintain plasma; as a carrier, it transports many ions, nutrients, metabolites and other compounds (such as drugs and hormones) in the human body to the corresponding Acting organs or excretory organs, promoting their physiological and pharmacological effects; as an important basic nutrient for the human body, they play an indispensable role in maintaining normal life activities. Human blood albumin has been used clinically for nearly 100 years. Human blood albumin can quickly supplement the body with a large amount of protein nutrition and significantly improve the body's hypoalbuminemia. It is suitable for patients admitted to the hospital for surgery, patients with cancer undergoing radiotherapy or chemotherapy, burn patients, patients with liver disease , Patients with kidney disease, patients with diabetes, patients with edema, women with too much blood loss, and people with chronic illnesses.

Existing blood products

Human albumin, human placental albumin, intravenous human immunoglobulin, intramuscular human immunoglobulin, histamine human immunoglobulin, specific immunoglobulin, hepatitis B immunoglobulin, rabies immunoglobulin, There are 13 products including tetanus immunoglobulin, human factor , human thrombin complex, human fibrinogen, and anti-human lymphocyte immunoglobulin. Products currently undergoing clinical research include lyophilized human thrombin, S / D-FFP, antithrombin-III, and lyophilized human fibrin adhesive for external use.

Blood products albumin products

Usually refers to albumin products with a concentration of 20-25 g / dl. Mainly used to correct acute blood volume reduction caused by major surgery, trauma, organ transplantation, etc .; deal with imbalances of body fluid, water, electrolyte and colloid caused by large area burns, respiratory distress, etc. to prevent and control shock; hypoproteinemia .

Blood products immunoglobulin products

Normal human immunoglobulin: mainly used for the prevention of certain viral infectious diseases, such as hepatitis A and measles.

Specific immunoglobulin: Compared with normal human immunoglobulin, it has the advantage of more reliable preventive effect, and some also have a positive therapeutic effect.

Blood products intravenous immunoglobulin products

When used, it has better tolerance to large-dose intravenous injections. In addition, the virus inactivation step is increased in the production process to improve safety. The clinical indications are increasing, and the application is becoming increasingly widespread. It is the leading product in the blood product industry today.

Blood products coagulation factor products

Fibrin adhesive: used in the fields of plastic surgery, microsurgery and neurosurgery. The product is processed by virus inactivation during the production process, which improves the safety of use.

Factor VIII blood products

For the treatment of hemophilia A. Factor VIII products with specific activities of 0.2 to 1.0 IU / mg protein and> 10 IU / mg protein, respectively, are not only small in size, high in titer, and convenient for home use, but because of the higher purity, coupled with the production process Virus inactivation treatment is carried out in the process, so there are fewer adverse reactions in use and higher safety.

Blood products prothrombin complex concentrates

Contains four clotting factors , , , and X. It is not only used for the treatment of congenital factor VII deficiency hemophilia B and rare congenital factor VII and factor XX deficiency disorders, but also for liver diseases, etc. Treatment of acquired bleeding disorders with multiple coagulation factor deficiencies and hemophilia A with factor VIII inhibitors.

Other instructions for blood products

Red blood cells are used to restore hemoglobin. Patients with abnormal blood volume may still have sufficient Hb as low as 70g / L

Blood products Oxygen capacity. Before the infusion, the doctor must consider the patient's age, the cause and severity of the anemia, the stability of the blood circulation, and the condition of the heart, lungs, and blood vessels. When only blood volume expansion is needed, other fluids can be combined or separately replenished.

Freeze-thaw red blood cells are mainly used in patients with antibodies against multiple blood groups or antibodies against high frequency antigens.

Washed red blood cells are almost completely free of plasma, and most white blood cells and platelets are removed. It is generally suitable for patients with severe reactions to plasma such as severe allergies or IgA immunity (see Section 147 Selective IgA Deficiency). Blood transfusions to IgA immune patients are best obtained from IgA-deficient donors.

Leukocyte-removed red blood cells are prepared through a special filter to remove 99.9% white blood cells. Although washed red blood cells can be used in those cases that are caused by an increase in cytokines in stored blood (pooled blood), the application of red blood cells to remove white blood cells has largely replaced washed red blood cells in preventing repeated febrile transfusion reactions. . Leukocyte-removed red blood cells can also be used to prevent transfusion-associated cytomegalovirus infection and platelet alloimmunity.

Platelet concentrates are used for severe thrombocytopenia (platelet <10,000 / l) bleeding, or less severe but associated with thrombocytopenia. It can also be used after a large amount of blood transfusion or prolonged extracorporeal circulation. Since a platelet concentrated preparation generally increases the platelet count by about 10,000 / l. When the number of platelets reaches about 50,000 / l, it is sufficient for hemostasis. Therefore, 6 to 8 random platelet concentrated preparations are usually required for adult patients.

When platelets (or other cells) are collected by an automated cell separator, unwanted components such as red blood cells and plasma can be returned to the donor, and a large number of platelets can be prepared. Although this procedure is more time-consuming than whole blood collection, platelets from a single donor are sufficient for transfusion into an adult patient.

Some patients do not respond to platelet transfusions, which may be due to spleen retention or platelet depletion mediated by antibodies against HLA or platelet-specific antigens. For patients who will be described later, blood cells can be collected by cell separation (platelet separation), but platelets that are not considered as donors for bone marrow transplantation, or platelets collected from HLA or platelet cross-compatible donors can be treated. Leukocyte-removed red blood cells and leukocyte-removed platelets can alleviate the same immune response by infusion.

Fresh frozen plasma (FFP) is the source of all unconcentrated coagulation factors except platelets. Can be used for bleeding when there is a lack of coagulation factors and no specific coagulation factors can be replenished; a variety of coagulation factors are lacking (such as DIC, liver failure, and warfarin for the treatment of acute bleeding excess). If no whole blood is available during replacement blood transfusion, it can also be added to red blood cells. Expansion of blood volume should not be the sole purpose of using FFP (crystal solution can often be used for blood volume expansion).

Cryoprecipitated anti-hemophilia factor (Factor VIII) is a concentrated preparation made from fresh frozen plasma. Each concentrate often contains factor I, factor about 80u, factor : VWF and fibrinogen about 250mg. Originally used for hemophilia, vascular hemophilia, and disseminated intravascular coagulation (DIC), it has recently become a source of fibrinogen in cardiothoracic surgery (fibrin jelly preparations) and obstetric emergencies. In general, the concentrate should not be used elsewhere (currently the best treatment for hemophilia and vascular hemophilia is the use of recombinant or inactivated virus concentrates and DDAVP).

Granulocytes can be used in patients with sepsis and severe antibiotic insensitivity due to severe agranulocytosis (leukocytes <500 / l). The collected granulocytes should be transfused to the patient within 24 hours. Prior to the transfusion, routine infectious disease tests such as HIV, hepatitis, HTLV, and syphilis need not be performed.

Rh immunoglobulin (RhIg) must be given to Rh-negative women immediately after miscarriage or childbirth (live or stillbirth), unless the baby is Rh0 (D) and Du-negative, and the maternal serum already contains anti-Rh0 (D ) Antibody or maternal refusal. An intramuscular injection of a standard dose of 300 g of RhIg prevents allergic reactions caused by fetal mother hemorrhage (FMH) in 30 ml of whole blood. The screening rosette test (screening rosette test) was used to determine the maternal bleeding volume of FMH> 30ml, and the dose required to prevent allergic reactions was calculated according to the above-mentioned medication standards. If the test is positive then a quantitative test (eg Kleihauer-Betka) is performed. RhIg intravenous administration is mainly limited to the treatment of idiopathic thrombocytopenic purpura in Rh-positive individuals or when contraindication to intramuscular administration (such as intramuscular bleeding).

Blood products storage temperature and time

Blood products	Storage temperature	Storage time
Whole blood and red fine preparation	2 6	21 days (ACD)
Whole blood and red fine preparation	2 6	35 days (CDPA-1)
Washing red blood cells	2 6	24 days
Platelet concentrate	20 24	7 days
Granulocyte	20 24	24h
Fresh frozen plasma, frozen plasma, cryoprecipitate	<-30	1 year
Cryopreserved red blood cells	<-65	10 years

Production status of blood products

There are thirty-four blood product manufacturers in China, and more than twenty of them are operating normally, and there are only more than ten with an annual plasma volume of more than 100 tons. Since the state has required all blood product companies to use mechanical harvesting since 1998, the cost per ton of albumin has increased by nearly 10 million yuan. Coupled with the slump in the domestic economy in the past two or three years, insufficient demand for related products, and the difficulty of sales of various companies 'products has increased. The ex-factory prices of most companies' products are lower than the prices set by the state, and product profit margins have declined. The key to the survival of such enterprises is to use new technologies to reduce costs, and through technological innovation, to separate more drug proteins from plasma to increase profits. In terms of production technology, all domestic human albumin and human immunoglobulin products use the low-temperature ethanol method; more than 20% of production units use pressure filtration instead of centrifugation for liquid-solid separation, which greatly improves the products (mainly human blood Albumin), and changed the production process from the open operation of centrifugation to the closed operation of filter press. In order to improve the safety of blood products, all domestic blood products are added with a one-step or two-step removal / inactivation process as required. In terms of product quality, the quality of human blood albumin produced in China has reached the level of similar international products; human blood immunoglobulin for intravenous injection has a complete IgG subclass, complete Fc function, and some quality indicators of immunoglobulin (purity of the product, Monomer and dimer content and hepatitis B antibody content) are higher than the European Pharmacopoeia standards; the quality of lyophilized human factor VIII concentrated preparations and lyophilized human thrombin complexes still has a gap in quality compared with the European Pharmacopoeia. Compared with foreign blood product companies, the main problems in the domestic blood product industry are: there are many manufacturers, but the production scale is small; the comprehensive utilization of blood is not enough; there are still gaps in blood source management and strengthening the safety of blood products.

The blood product industry in China is in a state of severe supply shortage. The theoretical theoretical plasma demand in the country is 8,000 tons, while the total domestic pulp extraction volume in 2012 was only about 4,000 tons. The imbalance between supply and demand has led to a strong pattern of sellers in the blood product industry, creating a high industry boom degree.

According to the " Forecast and Analysis of China's Blood Product Industry Demand and Investment Forecast Analysis " ^[1] analysis, the blood product industry has a very simple rule-the richer the product line, the higher the profit rate. Because the raw materials for producing blood products are the same batch of plasma, if more products can be extracted from the same batch of plasma, the cost can be effectively diluted. The generally accepted model in the industry is to ensure basic profits with albumin, succinate and factor VIII as the main products, and then other products (mainly exempt, factor IX, fibrinogen, alpha-1 antitrypsin, PCC) Create additional profits. This requires companies to have advanced technology that can effectively separate as many types of proteins as possible from the same batch of plasma.

In recent years, with the sharp increase in the nutritional costs of pulpers and the increase in costs in testing and transportation, the blood product industry is facing the risk of rising overall costs and falling product gross margins. Although the impact in this regard can be eliminated by raising prices in the short term, since blood products have basically entered the national medical insurance, there is a greater risk of price reduction. Therefore, increasing technical investment, improving blood utilization, and optimizing product structure are the primary tasks for future development.

With the continuous improvement of domestic medical standards, increasing awareness of clinical applications of blood products, and continuous improvement of domestic medical guarantees, the proportion of albumin in the domestic blood product consumption structure will continue to decline. The ratio will continue to improve, and the consumption structure of blood products will continue to be optimized.

Blood products related laws

Regulations on blood products management

Blood Products Chapter 1

General

Article 1: In order to strengthen the management of blood products, prevent and control blood-borne diseases, and ensure blood

The quality of liquid products is formulated in accordance with the Drug Administration Law and the Law on the Prevention and Control of Infectious Diseases.

Article 2: These Regulations apply to the collection, supply and

Production and operation of blood products.

Article 3: The health administrative department of the State Council collects and supplies raw material plasma and produces blood products nationwide

Supervision and management of production and business activities.

The health administrative departments of the local people's governments at or above the county level collect,

The supply and production and operation of blood products shall be supervised and managed in accordance with the duties specified in Article 30 of these regulations.

Blood Products Chapter 2

Management of raw plasma

Article 4: The state implements a unified planning and setting system for single blood plasma collection stations.

The health administrative department of the State Council responded to the approval of the national demand for raw material plasma for production.

Layout, quantity, and scale establish overall plans. The health administrative departments of the people's governments of provinces, autonomous regions, and municipalities directly

The overall plan draws up the plan for setting up a single plasma collection station in the administrative area and the regional plan for collecting plasma, and submits it to the state affairs

Hospital health administrative department for the record.

Article 5: Plasma collection stations are set up by blood product production units or by the Ministry of Health Administration of the county-level people's government

The gate is set up, specializing in apheresis, and has independent legal personality. No other unit or individual may

Single event plasma activity.

Article 6: To set up apheresis plasma stations, the following conditions must be met:

(1) It conforms to the plan for the layout, number and scale of apheresis plasma stations;

(2) Having health professional and technical personnel compatible with the collected raw material plasma;

(3) Having a place and a sanitary environment suitable for the collected raw material plasma;

(4) having an identification system for identifying the donor;

(5) Plasma collection machinery and other facilities suitable for the collected raw material plasma;

(6) Technical personnel and necessary equipment for quality inspection of the collected raw material plasma.

Article 7; An application for the establishment of apheresis blood collection stations shall be first reviewed by the health administrative department of the county-level people's government.

Of the health administrative department of the people's government of a city, autonomous prefecture, or an agency set up by a people's government of a province or autonomous region

The health administrative agency reviews and agrees to report to the health administrative department of the people's government of the province, autonomous region, or municipality directly under the Central Government for examination and approval;

Those that meet the requirements shall be issued a "Plasma Collection Permit" by the health administrative department of the people s government of the province, autonomous region, or municipality directly under the Central Government, and reported to the health administrative department of the State Council for the record.

Apheresis plasma stations can only provide supplies within the area designated by the health administrative department of the people's government of the province, autonomous region, and municipality.

Plasma subjects are screened and plasma collected.

Article 8; The "Apheresis Plasma Permit" shall stipulate the validity period.

Article 9: Only one apheresis station can be set in a plasma collection area.

Plasma collection stations are strictly prohibited to collect plasma from donors and other personnel in undefined areas.

Article 10; Plasma collection stations must perform health checks on plasma donors; those who pass the check shall be counted by the people at the county level

The government health administrative department issued the "Supply Plasma Certificate."

Standards for health examination of plasma donors shall be formulated by the health administrative department of the State Council.

Article 11: The "Plasma Certificate" is set up by the health administrative department of the people's government of provinces, autonomous regions and municipalities.

Design and print. The "Certificate for Plasma" shall not be altered, forged or transferred.

Article 12; Plasma apheresis stands must identify and verify the donor before collecting plasma

"Plasma certificate for blood supply", if it is confirmed to be correct, the health examination and blood test can be performed in accordance with the prescribed procedures;

If the test is qualified, collect plasma in accordance with relevant technical operating standards and procedures, and establish a health check for those who supply plasma

And plasma supply records; if the inspection or test fails, the plasma collection station shall collect the "supply plasma certificate", and

Destroyed by the health administrative department of the people's government at the county level.

It is strictly forbidden to collect the plasma of those without the "supply plasma certificate".

The standards and procedures for the operation of plasma collection technology shall be formulated by the health administrative department of the State Council.

Article 13; Apheresis plasma stations can only supply to a blood product production unit with which a quality responsibility certificate has been signed.

Raw material plasma should be used, and it is strictly forbidden to supply raw material plasma to any other units.

Article 14; Apheresis blood collection stations must use apheresis blood collection machinery to collect plasma, and manual operation of blood collection is strictly prohibited

Pulp. The collected plasma must be stored frozen in a single serving and must not be mixed.

It is strictly forbidden to collect blood from a single plasma collection station or use the collected raw plasma for clinical purposes.

Article 15; The apheresis plasma station must use the product approval document number and be approved by the national drug and biological product inspection machine

Construct batch-by-lot qualified in vitro diagnostic reagents and qualified disposable plasma collection equipment.

After using disposable consumables such as plasma collection equipment, they must be destroyed in accordance with relevant national regulations and recorded

record.

Article 16; Packaging, storage, and transportation of raw plasma collected at a single plasma collection station must comply with national regulations

Set sanitary standards and requirements.

Article 17; Apheresis blood collection stations must be strictly in accordance with relevant regulations such as the Law on Prevention and Treatment of Infectious Diseases

Implement disinfection management and epidemic reporting system.

Article 18; Plasma collection stations should report to the health administrative department of the county-level people's government in their location every six months

For the collection of raw material plasma, the health administrative department of the municipality, autonomous prefecture people's government or province

, Health administrative agencies of the dispatching agencies established by the people's government of the autonomous region and the people's governments of provinces, autonomous regions and municipalities

Health administration. The health administrative department of the people's government of a province, autonomous region, or municipality directly under the Central Government shall report annually to the State Council's health

The administrative department summarizes the collection of raw material plasma in this administrative area.

Article 19; The state prohibits the export of raw material plasma.

Blood Products Chapter III

Management of blood product manufacturing units

Article 20; Newly constructed, reconstructed or expanded blood product production units shall be approved by the health administrative department of the State Council.

After the approval of the project review according to the overall plan, the health administrative department of the people's government of the province, autonomous region, and municipality directly

Review and approve according to the provisions of the Drug Administration Law.

Article 21; The production unit of blood products must meet the

The standards stipulated in the "Product Quality Management Regulations" have passed the examination by the health administrative department of the State Council,

The administrative department of government can only engage in the production of blood products after applying for a business license.

Article 22; Units producing blood products shall actively develop new varieties and improve the comprehensive utilization rate of plasma.

A blood product production unit producing domestically produced varieties must report to the health administrative department of the State Council in accordance with the law

Apply for product approval document number; For varieties that have not yet been produced in China, they must follow the national procedures and requirements for new drug approval.

Seek declaration.

Article 23. It is strictly forbidden to transfer, lease, lend or share the "drugs" with blood product production units.

Production Enterprise License "and product approval document number.

Article 24; A blood product production unit shall not report to a plasma collection station or a plasma collection station without a plasma collection license.

The plasma collection station and any other units that have not signed a quality responsibility certificate collect raw material plasma.

A blood product production unit shall not supply raw blood plasma to any other unit.

Article 25; Before the production of raw blood plasma, the blood product production unit must use the product approval

The serial number and the in vitro diagnostic reagents that have been qualified batch by batch by the National Drug and Biological Product Testing Agency

A comprehensive re-inspection of the pulp is carried out and inspection records are made.

If the raw material plasma fails the retest, it shall not be put into production and must be tested under the supervision of the provincial drug supervisor.

Destroy it in accordance with prescribed procedures and methods and record it.

If blood plasma-borne diseases are found after re-examination of the raw material plasma, the apheresis blood supply must be notified.

The pulp station shall be reported to the health administrative department of the people's government of the province, autonomous region and municipality.

Article 26; Blood products must undergo quality inspection before they leave the factory;

It is strictly forbidden to leave the factory.

Article 27; The establishment of a blood product business unit shall be conducted by the people's government of the province, autonomous region, or municipality directly under the Central Government.

The administrative department reviews and approves.

Article 28; The business unit of blood products shall have the refrigerated conditions and

A business person who is familiar with the variety being managed.

Article 29; Blood product production and operation units produce, package, store, transport, and manage blood products

, Should meet the health standards and requirements set by the state.

Blood Products Chapter 4

Supervision and management

Article 30; The health administrative departments of the local people's governments at or above the county level shall be responsible for

Supervision of apheresis plasma stations, plasma donors, raw plasma collection and supervision of blood product operating units in administrative areas

management.

The administrative departments of health of the people's governments of provinces, autonomous regions, and municipalities directly under the Central Government are responsible for their administrative areas in accordance with the provisions of these regulations.

Supervision and management of blood product production units within the company.

Supervisors of the health administrative departments of local people's governments at or above the county level may perform their duties in accordance with national regulations.

According to relevant regulations of the government, the relevant units shall not refuse and conceal samples and samples.

Article 31; The health administrative departments of the people's governments of provinces, autonomous regions, and municipalities directly under the Central Government organize an annual survey of the Bank.

Supervision and inspection of single plasma collection stations in the administrative area and annual registration.

Districts, municipalities, autonomous prefectures, people's governments, health administrative departments, or provinces, autonomous regions

The health administrative agency of the government conducts inspections of apheresis plasma stations in its administrative area every six months.

Article 32; Provincial drugs designated by the State Drug and Biological Product Certification Agency and the State Council's Health Administration

The product inspection agency shall, in accordance with these regulations and the standards and requirements stipulated by the state,

Products are regularly tested.

Article 33; The administrative department of health under the State Council is responsible for the examination, approval, and supervision of the import and export of blood products nationwide

Blood Products Chapter 5

Penalty;

Article 34; Violation of the provisions of these regulations without obtaining the health administration of the people's government of the province, autonomous region, or municipality

The Plasma Collection License issued by the department illegally engages in the organization, collection, supply, and resale of raw plasma

, The health administrative department of the local people's government at or above the county level shall ban them, and confiscate the illegal income and engage in illegal activities

Moving equipment, equipment, and fines of 5 times to 10 times the illegal income, if there is no illegal income, and

Impose a fine of more than 50,000 yuan but less than 100,000 yuan; cause transmission of diseases transmitted by blood, personal injury, etc.

Whoever endangers and constitutes a crime shall be investigated for criminal responsibility according to law.

Article 35: If the apheresis plasma station has any of the following behaviors, the local people's government at or above the county level shall conduct health care.

The political department ordered a correction within a time limit and imposed a fine of 50,000 yuan up to 100,000 yuan; for any of the acts listed in item 8,

Or if any of the following acts are serious and the circumstances are serious, the Ministry of Health Administration of the People's Government of the province, autonomous region, or municipality directly under the Central Government

Door revoked the "Plasma Plasma Permit"; if it constitutes a crime, the person in charge directly responsible and other direct

Responsible personnel shall be investigated for criminal responsibility according to law:

(1) Prior to the collection of plasma, the plasma was not supplied in accordance with the health inspection standards issued by the health administrative department of the State Council.

Who perform health checks and blood tests;

(2) Collection of plasma from donors or other personnel in non-designated areas

For identification and collection of blood from impostors, those who failed the medical examination, or those without a "supply plasma certificate"

Pulp

(3) Violating the operating standards and procedures for plasma collection technology formulated by the health administrative department of the State Council

Amount of plasma collected;

(4) directly supplying raw material plasma to a medical institution or collecting blood without authorization;

(5) Plasma collection has not been performed using a single plasma collection machine;

(6) Those who have not used the product approval number and have passed the batch-by-batch inspection by the national drug and biological product inspection agency

In vitro diagnostic reagents and qualified disposable plasma collection equipment;

(7) Failure to package, store, or transport raw material plasma in accordance with the sanitary standards and requirements set by the state;

(8) The plasma that is positive for the test results of the state-specified test items is not removed and not reported in time;

(9) Dumping contaminated syringes, plasma collection equipment and unqualified plasma without disinfection

That pollute the environment and cause social harm;

(10) Repeated use of disposable plasma collection equipment;

(11) Supply of raw materials to units other than the blood product production unit with which the quality responsibility agreement has been signed

Plasma.

Article 36: The apheresis plasma station has known that the collected plasma test results are positive and still produce blood products.

If the supply is from an industrial unit, the health administration department of the people s government of the province, autonomous region, or municipality directly under the Central Government shall revoke the Plasma Collection License

Certificates "shall be confiscated by the health administrative department of the local people s government at or above the county level and shall be punished by more than 100,000 yuan3

A fine of less than RMB 10,000; causing diseases such as blood-borne diseases and personal injury, which constitutes a crime

, The person in charge directly responsible and other persons directly responsible shall be investigated for criminal responsibility in accordance with the law.

Article 37; If the "Supply Plasma Certificate" is altered, forged or transferred, the Ministry of Health Administration of the county-level people's government

Seized the "Providence for Plasma", confiscated the illegal income, and imposed a fine of 3 times to 5 times the illegal income.

Those with illegal income shall be imposed a fine of less than 10,000 yuan; if a crime is constituted, criminal liability shall be investigated in accordance with the law.

Article 38; If a blood product production unit commits one of the following acts, it shall be sanitary by the people's government at or above the provincial level

The administrative department shall punish the production of counterfeit medicines and inferior medicines in accordance with the relevant regulations of the Drug Administration Law and its implementation measures.

; If a crime is constituted, the person in charge and other persons directly responsible shall be investigated for criminal responsibility in accordance with the law

: (1) Those who use an apheresis plasma station without an apheresis plasma license or have not signed a quality responsibility certificate with them

Those who collect raw material plasma from plasma stations and any other units, or illegally collect raw material plasma;

(2) The raw material plasma has not been re-tested before production, or the product approval number is not used or

If the in-vitro diagnostic reagents that have not been qualified batch by batch by the National Drug and Biological Product Examination Agency have been re-examined, or

Testing of unqualified raw material plasma into production;

(3) unauthorized changes in production technology and quality standards, or leaving the unqualified products out of the factory;

(4) Sharing the product approval document number with others.

Article 39; The blood product production unit violates the provisions of these regulations and transfers or leases to other units without authorization.

, Lending, and sharing with others the Drug Manufacturing Enterprise License, product approval number, or supply of raw material plasma

, The administrative department of health of the people s government at or above the provincial level shall confiscate the illegal income and impose more than five times the illegal income10

If there is no illegal income, a fine of more than 50,000 yuan but less than 100,000 yuan shall be imposed.

Article 40; In violation of the provisions of these Regulations, blood product production and operation units produce, pack, store, and transport

If the operation of blood products does not meet the health standards and requirements set by the state, the people of the province, autonomous region and municipality

The government health administrative department orders corrections and can impose a fine of less than 10,000 yuan.

Article 41; Among the products to be shipped from the finished product warehouse of the blood product production unit,

If it fails to meet the national regulations and is still unqualified after re-inspection, the health administrative department of the State Council shall revoke the blood product

Approval Number.

Article 42; In violation of the provisions of these regulations, the unauthorized import and export of blood products or the export of raw material plasma,

The health administrative department of the people's government at or above the provincial level has confiscated the imported and exported blood products or the exported raw material plasma and

The total value of blood products imported or exported from the premises and the plasma of raw materials imported or exported is 3 times to 5 times

Fine.

Article 43; blood product inspection personnel falsely report, conceal, alter, forge inspection reports and related materials

Administrative sanctions shall be imposed in accordance with law; if a crime is constituted, criminal liability shall be investigated in accordance with law.

Article 44: Staff of the health administrative department abuses their powers, neglects their duties, engages in malpractices, and asks for bribes

Bribery, if it constitutes a crime, shall be investigated for criminal responsibility according to law; if it does not constitute a crime, administrative sanctions shall be imposed according to law.

Blood Products Chapter 6

Attached;

Article 45; the meaning of the following terms in these regulations:

Blood products refer to various human plasma protein products.

The raw material plasma refers to the blood plasma collected by the apheresis plasma station and used exclusively for the production of raw materials for blood products.

Plasma donor refers to the person who provides the plasma of raw materials for the production of blood products.

An apheresis plasma station refers to the establishment of a blood collection station based on regional blood source resources, in accordance with relevant standards and requirements, and after strict approval.

Units that collect and supply raw blood plasma for the production of blood products.

Article 46; Collection and supply of raw material plasma and price standards and price management measures for blood products,

It shall be formulated by the price management department of the State Council together with the health administration department of the State Council.

Article 47; The apheresis plasma stations and blood product production and operation units that have been established before the implementation of these regulations shall

Within 6 months from the date of implementation of these regulations, re-examination and approval procedures shall be conducted in accordance with the provisions of these regulations;

All provisions of these regulations shall be closed.

The time when the apheresis plasma station which has been established before the implementation of these regulations shall be applicable to Article 6, Item 5 of these regulations shall be governed by

The health administrative department of the hospital shall separately stipulate.

Article 48; These Regulations shall become effective on the date of promulgation.