The blood product industry carries out Gmp renewal inspection every 5 years, while accepting flight inspection at any time. more than 30 blood product enterprises overwhelmingly most of them can pass the acceptance, there are one or two of them have to be non-stop rectification and then complete, or in the flight inspection of the problem.
fkc whether the United States fda gmp certified manufacturersThe United States Food and Drug Administration (Food and Drug Administration) referred to as the FDA FDA is the United States *** in the Department of Health and Human Services (DHHS) and the Department of Public *** Department of Health (PHS) to establish one of the executive agencies As a scientific and regulatory agency, FDA As a scientific regulatory agency, FDA is responsible for ensuring the safety of food, cosmetics, drugs, biologicals, medical devices, and radiological products manufactured in or imported into the United States. It was one of the first federal agencies whose primary function was to protect consumers. The agency is relevant to the lives of every U.S. citizen. Internationally, the FDA is recognized as one of the largest food and drug regulatory agencies in the world. Many other countries seek and receive help from the FDA to promote and monitor the safety of their own products. The Food and Drug Administration (FDA) is responsible for the supervision and inspection of food, drugs (including veterinary drugs), medical devices, food additives, cosmetics, animal food and drugs, wine beverages with an alcohol content of less than 7%, as well as electronic products; and the testing, inspection, and certification of ionic and non-ionic radiation affecting human health and safety in the use or consumption of products. According to the regulations, the above products must be tested and certified as safe by the FDA before they can be sold on the market, and the FDA has the right to inspect manufacturers and prosecute violators. According to the supervision of different product range, can be divided into the following major regulatory agencies: 1, the Center for Food Safety and Practical Nutrition (CFSAN): the center is the FDA's largest workload. It is responsible for food safety throughout the United States in addition to meat, poultry and eggs under the jurisdiction of the U.S. Department of Agriculture. Although the U.S. has one of the safest food supplies in the world, approximately 76 million foodborne illnesses occur each year, 325,000 people are hospitalized for foodborne illnesses, and about 5,000 people die from foodborne illnesses. The Center for Food Safety and Nutrition works to reduce foodborne illness and promote food safety. It also promotes a variety of programs, such as the promotion of HACCP programs. The functions of the Center include: ensuring the safety of new substances and colors added to foods; ensuring the safety of foods and ingredients developed through biological processes; being responsible for regulatory activities in the proper labeling of foods (e.g., ingredients, nutritional health proclamations) and cosmetics; developing appropriate policies and regulations for the management of dietary supplements, infant food formulas, and medical foods; ensuring the safety of cosmetic ingredients and products, and ensuring proper labeling; monitoring and regulating post-sale behavior in the food industry; consumer education and behavioral outreach; collaborative projects with state and local ***; and coordination of international food standards and safety, among others. 2. Center for Drug Evaluation and Research (CDER): The CDER is designed to ensure the safety and effectiveness of prescription and over-the-counter drugs by evaluating new drugs before they are introduced to the market and monitoring more than 10,000 drugs on the market to ensure that the products meet the highest standards, which are constantly updated. The Center also regulates the truthfulness of advertisements for medicines on television and radio, as well as in publications. Strict monitoring of medicines provides consumers with accurate and safe information. 3. Center for Device Safety and Radiation Health (CDRH): The CDRH ensures the safety and effectiveness of newly marketed medical devices. More than 20,000 companies around the world manufacture more than 80,000 different types of medical devices, from glucose monitors to artificial heart valves. Since these products are closely related to human life, the Center also oversees nationwide after-sales service. The Center also sets safety standards for products that produce radiation, such as microwave ovens, televisions and cellular phones. 4. Center for Biological Evaluation and Research (CBER): This center regulates biological products that can prevent and treat diseases, so it is more complicated than chemical synthesis drugs, including scientific research on the safety and effectiveness of blood, plasma, vaccines and so on. 5, Center for Veterinary Medicines (CVM): The Center regulates food and medicines for animals to ensure that these products in life-sustaining, pain relief, etc. practicality, safety and effectiveness.
What pharmaceutical manufacturers are GMP certified?There seem to be more than 6,000 that have passed the 98th edition,
The new version of GMP has passed the inspection of the National Bureau of only more than 100,
The total number of provincial bureau inspections seems to be no more than 500.
What are the blood products? What kind of enterprises can produce?Regulations on the Administration of Blood Products Chapter I General Provisions Article 1 In order to strengthen the management of blood products, prevention and control of blood-borne diseases, to ensure the quality of blood products, according to the Drug Administration Law and the Prevention and Control of Infectious Diseases Law, the enactment of these regulations. Article 2 These Regulations shall apply to the collection and supply of raw plasma and the production and operation of blood products within the territory of the People's Republic of China. Article 3 The health administrative department of the State Council shall supervise and manage the collection and supply of raw plasma and the production and operation of blood products throughout the country. The local people's *** health administrative departments at or above the county level shall exercise supervision and management over the collection and supply of raw plasma and the production and operation of blood products in their own administrative areas in accordance with the responsibilities stipulated in Article 30 of these Regulations. Chapter II Management of Raw Material Plasma Article 4 The State implements a system of unified planning and setting of single plasma collection stations. The health administrative department of the State Council shall, according to the approved demand for raw plasma for national production, formulate a general plan for the layout, number and scale of single plasma collection stations. The people's health administrative departments of provinces, autonomous regions and municipalities directly under the Central Government shall, in accordance with the overall plan, formulate plans for the setting up of single-collection plasma stations and regional plans for the collection of plasma in the administrative regions, and report them to the health administrative department of the State Council for the record. Article 5 A single-collection plasma station shall be set up by a blood product production unit or by a county-level people's *** administrative department of health, and shall specialize in single-collection plasma activities and have independent legal personality. No other unit or individual shall engage in single-collection plasma activities. Article 6 The establishment of a single plasma collection station must have the following conditions: (1) in line with the single plasma collection station layout, number, scale of planning; (2) with the collection of raw material plasma compatible health professionals and technicians; (3) with the collection of raw material plasma compatible with the premises and sanitary environment; (4) with identification of plasma supplier identification system; (5) with the collection of raw material plasma compatible with the single plasma collection machinery and other facilities. (E) With machinery and other facilities suitable for the collection of raw plasma; (F) With technicians for quality inspection of the collected raw plasma and the necessary instruments and devices. Article 7 The application for the establishment of a single plasma station, by the county-level people *** health administrative department for the first time, by the district of the city, the Autonomous Prefecture people *** health administrative department or province, autonomous region people *** set up by the dispatching authorities of the health administrative organs for examination and consent, reported to the province, autonomous region, province directly under the Central Government *** people *** health administrative department for examination and approval; after examination meets the requirements, by the province, autonomous region, province directly under the Central Government *** people *** health administrative department issued a "single plasma collection". The single plasma collection station can only screen and collect plasma from the plasma suppliers within the area designated by the health administrative department of the people's *** province, autonomous region or municipality directly under the Central Government. Article 8 The Single Plasma Collection License shall be valid for a specified period of time. Article 9 In a plasma collection area, only one single plasma collection station can be set up. It is strictly prohibited for a single plasma collection station to collect plasma from plasma suppliers and other persons not within the demarcated area. Article 10 single plasma collection stations must be plasma donors health checks; qualified by the county-level people *** health administrative department issued a "plasma supply certificate. For plasma health inspection standards, by the State Council administrative department of health. Article 11 "plasma supply certificate" by the province, autonomous region, municipality directly under the Central People's *** health administrative department is responsible for the design and printing. Plasma supply certificate shall not be altered, forged or transferred. Article 12 Before collecting plasma, a single plasma collection station must identify the plasma supplier and verify his/her Plasma Supply Certificate, and only if it is confirmed that there is no error can it carry out a health examination and blood test according to the prescribed program; if the examination and test are qualified, it shall collect plasma according to the relevant technical operation standards and program, and establish a file of plasma supplier's health examination and record of plasma supply; if the examination and test fail, the single plasma collection station shall take away the Plasma Supply Certificate and the Plasma Supply Certificate, which is the responsibility of the provincial, autonomous region and municipality directly under the Central People's Government. In case of unqualified examination and laboratory test, the single plasma collection station shall collect the "plasma supply certificate" and destroy it under the supervision of the local county-level people's *** health administrative department. It is strictly prohibited to collect plasma from those who do not have the Plasma Supply Certificate. Plasma collection technical operation standards and programs, developed by the State Council administrative department of health. Article 13 A single plasma station can only supply raw plasma to a blood product production unit with which it has signed a quality responsibility statement, and it is strictly prohibited to supply raw plasma to any other unit. Article 14 The mono-collecting plasma station must use the mono-collecting plasma machinery to collect plasma, and manual collection of plasma is strictly prohibited. The collected plasma must be frozen and stored in single portions, and no mixing of plasma is allowed. It is strictly prohibited for the mono-collecting plasma stations to collect blood or use the collected raw plasma for clinical purposes. Article 15 The single-collection plasma station must use in vitro diagnostic reagents and qualified disposable plasma-collecting equipments that have product approval numbers and have been qualified by the State Drug and Biological Products Certification Organization on a batch-by-batch basis. After the use of plasma collection equipment and other disposable consumables, they must be destroyed and recorded in accordance with relevant state regulations. Article 16 The packaging, storage and transportation of raw plasma collected by single-collecting plasma stations must comply with the hygienic standards and requirements stipulated by the state. Article 17 The single-collection plasma station must strictly implement the disinfection management and epidemic reporting system in accordance with the Law on Prevention and Control of Infectious Diseases and its implementing measures and other relevant provisions. Article 18 The single plasma station should be half a year to the location of the county-level people's *** health administrative department to report on the collection of plasma raw materials, while copying to the city, autonomous region people's *** health administrative department or province, autonomous region people's *** set up by the dispatching authorities of the health administrative agencies and provinces, autonomous regions, municipalities directly under the Central People's *** health administrative department. Provinces, autonomous regions, municipalities directly under the Central People's *** health administrative departments shall report annually to the State Council administrative department of health to summarize the collection of raw plasma in the administrative region. Article 19 The state prohibits the export of raw plasma. Chapter III Management of Blood Products Production and Operation Units Article 20 The new construction, alteration or expansion of blood products production units, by the State Council administrative department of health in accordance with the overall planning of the project review and approval by the provinces, autonomous regions and municipalities directly under the Central People's *** Health Administration in accordance with the provisions of the Drug Administration Law of the audit approval. Article 21 The production units of blood products must meet the standards stipulated in the "Good Manufacturing Practice for Drugs" formulated by the health administrative department of the State Council, and be examined and qualified by the health administrative department of the State Council, and apply for a business license from the administrative department of industry and commerce according to the law before they can engage in the production activities of blood products. Article 22 The production units of blood products shall actively develop new varieties and improve the comprehensive utilization rate of plasma. The production units of blood products shall apply for product approval number to the health administrative department of the State Council in accordance with the law for the production of the domestically produced varieties; for the domestically unproduced varieties, they shall declare in accordance with the procedures and requirements for the approval of the new drugs of the State. Article 23 It is strictly prohibited for the blood product manufacturing units to transfer, lease, lend and use with others*** the Drug Manufacturing Enterprise License and product approval number. Article 24 The production units of blood products shall not collect raw plasma from the single plasma station without "Single Plasma Collection License" or the single plasma station which has not signed the quality responsibility statement with it, or any other units. A blood product manufacturing unit shall not supply raw plasma to any other unit. Article 25 Before putting raw plasma into production, the blood product production unit must use in vitro diagnostic reagents with product approval number and qualified batch by batch by the State Drug and Biological Product Inspection and Quarantine Organization, and carry out a comprehensive re-inspection of each individual portion of blood plasma and make records of the inspection. If the raw plasma fails to pass the re-inspection, it shall not be put into production and must be destroyed under the supervision of provincial drug supervisors in accordance with the stipulated procedures and methods, and records shall be made. Raw plasma by the re-examination found to have blood-borne diseases, must notify the supply of plasma plasma station, and promptly reported to the local provinces, autonomous regions, municipalities directly under the Central People's *** health administrative departments. Article 26 Before blood products leave the factory, they must undergo quality inspection; if the inspection does not conform to the national standards, they are strictly prohibited to leave the factory. Article 27 The establishment of blood products business unit, by the province, autonomous region, municipality directly under the Central People's *** health administrative department audit approval. Article 28 The blood products business unit should have and the products operated by the appropriate conditions of refrigeration and familiar with the operation of the varieties of business personnel. Article 29 The production of blood products production and management units, packaging, storage, transportation, operation of blood products, shall comply with the state health standards and requirements. Chapter IV Supervision and Administration Article 30 The local people's *** health administrative departments at or above the county level shall be responsible for the supervision and administration of single plasma stations, plasma suppliers, collection of raw plasma, and business units of blood products in the administrative region in accordance with the provisions of these Regulations. The people's *** health administrative departments of provinces, autonomous regions and municipalities directly under the central government are responsible for the supervision and management of blood product manufacturing units within their respective administrative regions in accordance with the provisions of these Regulations. When the supervisors of the local people's *** administrative departments of health at or above the county level carry out their duties, they may take samples and request relevant information in accordance with the relevant state regulations, and the relevant units shall not refuse or conceal them. Article 31 The people's *** health administrative departments of provinces, autonomous regions and municipalities directly under the Central Government shall once a year organize the supervision and inspection of single-collecting plasma stations in their respective administrative regions and carry out annual registration. The people's *** health administrative departments of cities and autonomous prefectures in the districts, or the health administrative agencies of the organs set up by the people's *** of the provinces and autonomous regions, conduct inspections of single-collecting plasma stations in their respective administrative regions once every six months. Article 32 The national testing organizations for pharmaceutical and biological products and the provincial-level drug testing organizations designated by the health administrative department under the State Council shall, in accordance with these Regulations and the standards and requirements stipulated by the State, regularly test the products produced by blood product manufacturing units. Article 33 The health administrative department of the State Council is responsible for the approval and supervision of the import and export of blood products.
GMP is a mandatory requirement, but it is not mandatory to be certified.
HACCP is also a requirement, but certification is not mandatory.
Just like the six categories of products required by export food mouth enterprises, the implementation of official HACCP verification is required, but did not say mandatory certification.
GMP is an acronym for GOOD MANUFACTURING PRACTICE, which means "Good Manufacturing Practice" in Chinese. The World Health Organization defines GMP as a set of regulations that guide the production and quality management of food, pharmaceuticals, and medical products. GMP is a set of mandatory standards applicable to the pharmaceutical, food, and other industries that require companies to meet hygiene and quality requirements from raw materials, personnel, facilities and equipment, production processes, packaging and transportation, and quality control according to the relevant national regulations to form a set of actionable practices to help improve the corporate health environment and timely detection of production processes. Hygienic environment, timely detection of problems in the production process, to improve. GMP requires that pharmaceutical and food manufacturers have good production facilities, reasonable production processes, good quality management and strict testing systems to ensure that the final product quality (including food safety and hygiene) meets the requirements of the law.
HACCP denotes Hazard Analysis Critical Control Point. It is a scientific, rational and systematic approach to ensuring the safety of food in the production, processing, manufacturing, preparation and consumption of food for consumption, in terms of hazard identification, evaluation and control. However, it does not represent an unacceptable threat to health. The identification of possible links in the food production process and the adoption of appropriate control measures to prevent the occurrence of hazards. By monitoring and controlling each step of the process, the probability of a hazard occurring is reduced.
In HACCP, there are seven principles that serve as the basis for the implementation of the system, and they are
1 Implementation of Hazard Analysis;
2 Determination of Critical Control Points (CCPs), a CCP is a step at a critical point at which control is implemented. It is important in preventing or eliminating food safety risks or reducing them to an acceptable level;
3 Determination of critical constraints (a critical factor can satisfy one CCP guideline);
4 Establishment of a system to monitor CCPs;
5 Implementation of actionable corrective actions when monitoring indicates that a CCP is out of control;
6 Establishment of a system to ensure that HACCP systems are effective;
6 Establish a validation program to ensure the effective operation of the HACCP system;
7 Establish and archive records covering all programs and implementation against these principles.
What qualifications are required for a food manufacturer?
Food production requires a food production license, and health food requires a health food approval certificate. All plasma is now done by mono-collecting plasma stations for a fee.
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