Fkc is a manufacturer certified by FDA and GMP in the United States. The US Food and Drug Administration is one of the executive agencies established by the United States in the Department of Health and Human Services (DHHS) and the Department of Health (PHS). As a scientific management organization, FDA is responsible for ensuring the safety of food, cosmetics, medicines, biological agents, medical devices and radiation products produced or imported in the United States. It is one of the earliest federal agencies, whose main function is to protect consumers. This institution is closely related to the life of every American citizen. Internationally, FDA is recognized as one of the largest food and drug administrations in the world. Many other countries seek and accept the help of FDA to promote and monitor the safety of their own products. Director of the US Food and Drug Administration (FDA): Supervise and inspect foods, medicines (including veterinary drugs), medical devices, food additives, cosmetics, animal foods and medicines, wines and beverages with alcohol content below 7%, and electronic products; Ionized and non-ionic radiation produced in the process of product use or consumption affects the testing, inspection and certification of human health and safety projects. According to the regulations, the above products can only be sold in the market after being tested and proved safe by FDA. The FDA has the right to inspect manufacturers and prosecute offenders. According to the range of products regulated, it can be divided into the following main regulatory agencies: 1, Center for Food Safety and Practical Nutrition (CFSAN): the center is the department with the largest workload of the FDA. It is responsible for food safety in the United States except meat, poultry and eggs under the jurisdiction of the United States Department of Agriculture. Although the United States is the country with the safest food supply in the world, there are still about 76 million cases of food-borne diseases every year, 325,000 people need hospitalization due to food-borne diseases, and about 5,000 people die from food-borne diseases. The Center for Food Safety and Nutrition is committed to reducing food-borne diseases and promoting food safety. And promote the promotion and implementation of various plans, such as HACCP plan. The functions of the center include: ensuring the safety of new substances and pigments in food; Ensure the safety of food and ingredients developed through biotechnology; Responsible for the management activities of correctly labeling food (such as ingredients, nutrition and health announcements) and cosmetics; Formulate corresponding policies and regulations to manage dietary supplements, infant formula foods and medical foods; Ensure the safety of cosmetic ingredients and products, and ensure correct identification; Supervise and standardize the after-sales behavior of the food industry; Conduct consumer education and behavior development; Cooperation projects with state and local governments; Harmonize international food standards and safety. 2. Drug Evaluation and Research Center (CDER): This center aims to ensure the safety and effectiveness of prescription drugs and over-the-counter drugs, evaluate new drugs before they are put on the market, and supervise more than10,000 drugs on the market to ensure that the products meet the highest standards that are constantly updated. At the same time, the center also supervises the authenticity of drug advertisements on TV, radio and publications. Strictly supervise drugs to provide accurate and safe information for consumers. 3. Center for Equipment Safety and Radiation Protection Health (CDRH): This center is responsible for ensuring the safety and effectiveness of newly listed medical equipment. Because there are more than 20,000 enterprises around the world producing more than 80,000 kinds of medical devices from blood glucose monitors to artificial heart valves. These products are closely related to people's lives, so the center also supervises after-sales service nationwide. For some products that can produce radiation, such as microwave ovens, televisions, mobile phones, etc., the center has also determined some corresponding safety standards. 4. Biological Products Evaluation and Research Center (CBER): This center supervises biological products that can prevent and treat diseases, so it is more complicated than chemical comprehensive drugs. It includes scientific research on the safety and effectiveness of blood, plasma and vaccines. 5. Veterinary Medicine Center (CVM): This center supervises the food and medicine of animals to ensure the practicality, safety and effectiveness of these products in maintaining life and alleviating pain.
Which pharmaceutical manufacturers have obtained GMP certification? It seems that more than 6000 people have passed the 98 edition.
Only more than 100 GMP versions have passed the inspection of the National Bureau.
The total number of inspections by the provincial bureau seems to be no more than 500.
What are the blood products? What kind of enterprise can produce? Regulations on the Administration of Blood Products Chapter I General Provisions Article 1 In order to strengthen the administration of blood products, prevent and control blood-borne diseases and ensure the quality of blood products, these regulations are formulated in accordance with the Drug Administration Law and the Law on the Prevention and Control of Infectious Diseases. Article 2 These Regulations shall apply to the collection and supply of raw plasma and the production and marketing of blood products in People's Republic of China (PRC). Article 3 The administrative department of health of the State Council shall supervise and manage the collection and supply of raw plasma and the production and marketing of blood products throughout the country. The local people's health administrative departments at or above the county level shall, in accordance with the duties stipulated in Article 30 of these regulations, supervise and manage the collection and supply of raw plasma and the production and operation of blood products within their respective administrative areas. Chapter II Management of Raw Plasma Article 4 The State implements a unified planning and setting system for plasma collection stations. The administrative department of public health of the State Council shall, according to the production demand of raw plasma approved by the state, make an overall plan for the layout, quantity and scale of apheresis plasma stations. The people's health administrative departments of provinces, autonomous regions and municipalities directly under the Central Government shall, according to the overall planning, formulate the planning of plasma collection stations and regional planning of plasma collection within their respective administrative areas, and report them to the health administrative department of the State Council for the record. Article 5 A plasma collection station shall be established by a blood product production unit or the health administrative department of the people's government at the county level, which is specialized in plasma collection activities and has the qualification of an independent legal person. No other unit or individual may collect plasma from the activity list. Article 6 The establishment of plasma collection stations must meet the following conditions: (1) Conforming to the planning of the layout, quantity and scale of plasma collection stations; (2) Having health professionals suitable for the collected raw plasma; (3) Having a place and sanitary environment suitable for collecting raw plasma; (4) Having an identification system to identify the plasma donors; (5) Having plasma collection machinery and other facilities suitable for the collected raw plasma; (6) Having technicians and necessary instruments and equipment for quality inspection of the collected raw plasma. Article 7 The application for setting up apheresis plasma stations shall be first examined by the health administrative department of the people's government at the county level, and then examined and approved by the health administrative department of the people's government of a city or autonomous prefecture divided into districts or the health administrative department of an agency established by the people's government of a province or autonomous region. And 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; Upon examination, if it meets the requirements, the health administrative department of the people's government of the province, autonomous region or municipality directly under the Central Government shall issue the plasma collection permit and report it to the health administrative department of the State Council for the record. Plasma collection stations can only screen plasma donors and collect plasma in areas designated by the health administrative departments of provinces, autonomous regions and municipalities directly under the Central Government. Article 8 The license for collecting simplex shall specify the period of validity. Ninth in a plasma collection area, only one plasma collection station can be set up. It is strictly forbidden to collect plasma from plasma donors and other personnel in non-designated areas. Tenth plasmapheresis stations must carry out health examination for plasmapheresis; If it passes the inspection, the health administrative department of the people at the county level shall issue a plasma supply certificate. Health examination standards for blood donors shall be formulated by the health administrative department of the State Council. Article 11 The health administrative departments of provinces, autonomous regions and municipalities directly under the Central Government shall be responsible for the design and printing of the Certificate of Plasma Donation. "Plasmapheresis Certificate" shall not be altered, forged or transferred. Twelfth plasma collection station before collecting plasma, plasma donors must be identified, and verify the "plasma donor card". If diagnosed, health examination and blood test can be carried out in accordance with the prescribed procedures; For those who pass the inspection, collect plasma according to the relevant technical operating standards and procedures, and establish a health examination for plasma donors and a file for plasma donors; If the inspection and detection are unqualified, the plasma supply certificate shall be recovered by the plasma collection station and destroyed under the supervision of the local people's health administrative department at the county level. It is forbidden to collect plasma without plasma supply certificate. The operating standards and procedures of plasma apheresis technology shall be formulated by the health administrative department of the State Council. Thirteenth plasma collection stations can only supply raw plasma to a blood product production unit that has signed a quality responsibility letter with them, and it is strictly forbidden to supply raw plasma to any other unit. Fourteenth plasma collection stations must use plasma collection machinery to collect plasma, and manual collection of plasma is strictly prohibited. The collected plasma must be stored in a single frozen part, and mixing of plasma is not allowed. It is strictly forbidden to collect blood from apheresis plasma station or use the collected raw plasma in clinic. Fifteenth plasma collection stations must use the in vitro diagnostic reagents with product approval number and qualified by the national pharmaceutical and biological products verification institutions, as well as qualified disposable plasma collection equipment. Disposable consumables such as plasma collection equipment must be destroyed and recorded in accordance with relevant state regulations after use. Article 16 The packaging, storage and transportation of raw plasma collected by plasma collection stations must meet the hygienic standards and requirements stipulated by the state. Seventeenth plasma collection stations must strictly implement the disinfection management and epidemic reporting system in accordance with the relevant provisions of the Law on the Prevention and Control of Infectious Diseases and its implementation measures. Article 18 A plasma collection station shall report the collection of raw plasma to the local health administrative department at the county level every six months, and send a copy to the health administrative department of the people's government of a city or autonomous prefecture with districts, the health administrative department of the dispatched office established by the people's government of a province or autonomous region, and the health administrative department of the people's government of a province, autonomous region or municipality directly under the Central Government. The people's health administrative departments of provinces, autonomous regions and municipalities directly under the Central Government shall report the collection of raw plasma to the health administrative department of the State Council every year. Article 19 The State prohibits the export of raw plasma. Chap III administration of production and business units of blood product article 20 that newly built, rebuilt or expanded production units of blood products shall be examine and approved by the health administrative department of the State Council according to the overall plan, and then examined and approved by the health administrative departments of the people's governments of provinces, autonomous regions and municipalities directly under the Central Government in accordance with the provisions of the Drug Administration Law. Article 21 A production unit of blood products must meet the standards stipulated in the good manufacturing practice formulated by the administrative department of health of the State Council, pass the examination by the administrative department of health of the State Council, and apply for a business license from the administrative department for industry and commerce according to law before engaging in production activities of blood products. Twenty-second blood products production units should actively develop new varieties, improve the comprehensive utilization rate of plasma. If a blood product production unit produces varieties that have been produced in China, it must apply to the health administrative department of the State Council for the product approval number according to law; Varieties that have not yet been produced in China must be declared in accordance with the procedures and requirements of national new drug examination and approval. Article 23 It is strictly forbidden for the production unit of blood products to sell, lease, lend or * * use the Pharmaceutical Production Enterprise License and product approval number with others. Twenty-fourth blood products production units shall not collect raw plasma from plasma collection stations without plasma collection license, plasma collection stations without quality responsibility book or other units. The production unit of blood products shall not supply raw plasma to any other unit. Article 25 Before the raw plasma is put into production, the production unit of blood products must use the in-vitro diagnostic reagents with product approval number that have passed the batch-by-batch inspection by the national pharmaceutical and biological products inspection institutions, conduct a comprehensive re-inspection of each plasma, and make inspection records. Raw plasma that fails to pass the re-inspection shall not be put into production, and must be destroyed in accordance with the prescribed procedures and methods under the supervision of provincial drug supervisors, and records shall be made. If it is found that raw plasma has blood-borne diseases after re-inspection, it must notify the plasma collection station that provides plasma, and report to the health administrative department of the people's government of the province, autonomous region or municipality directly under the Central Government in time. Twenty-sixth blood products must undergo quality inspection before leaving the factory; Those that fail to meet the national standards after inspection are strictly prohibited from leaving the factory. Article 27 The establishment of a business unit of blood products shall be examined and approved by the health administrative department of the people's government of a province, autonomous region or municipality directly under the Central Government. Twenty-eighth blood products business units should have the refrigeration conditions suitable for the products they operate and the business personnel who are familiar with the varieties they operate. Article 29 The production, packaging, storage, transportation and sale of blood products by production and business units of blood products shall conform to the hygienic standards and requirements stipulated by the state. Chapter IV Supervision and Management Article 30 The health administrative department of the local people's government at or above the county level shall be responsible for the supervision and management of plasma collection stations, plasma collection persons, raw plasma collection and blood products business units within their respective administrative areas in accordance with the provisions of these Regulations. The health administrative departments of the people's governments of provinces, autonomous regions and municipalities directly under the Central Government shall be responsible for the supervision and management of blood products production units within their respective administrative areas in accordance with the provisions of these regulations. Supervisors of local people's health administrative departments at or above the county level may, when performing their duties, take samples and obtain relevant information in accordance with relevant state regulations, and the relevant units shall not refuse or conceal them. Article 31 The health administrative departments of the people's governments of provinces, autonomous regions and municipalities directly under the Central Government shall organize supervision and inspection of plasma collection stations within their respective administrative areas once a year, and make annual registration. The health administrative department of the people's government of a city or autonomous prefecture divided into districts or the health administrative department of an institution established by the people's government of a province or autonomous region shall conduct an inspection of the apheresis stations within their respective administrative areas every six months. Thirty-second national drug and biological products inspection institutions and provincial drug inspection institutions designated by the administrative department of health of the State Council shall regularly inspect the products produced by blood products production units in accordance with these regulations and the standards and requirements stipulated by the state. Article 33 The administrative department of health of the State Council is responsible for the examination, approval, supervision and management of the import and export of blood products nationwide.
Do dairy enterprises have to carry out GMP certification and HACCP certification? GMP is a mandatory requirement, but certification is not necessary.
HACCP is also required, but certification is not mandatory.
Just like the six types of products required by export food enterprises, they need official HACCP verification, but there is no mention of compulsory certification.
GMP is the abbreviation of English GOOD MANUFACTURING PRACTICE, which means "Good Manufacturing Practice" in Chinese. The World Health Organization defines GMP as a regulation that guides the production and quality management of food, drugs and medical products. GMP is a set of mandatory standards applicable to pharmaceutical and food industries, which requires enterprises to meet the hygiene and quality requirements in raw materials, personnel, facilities and equipment, production technology, packaging and transportation, and quality control. , and form a set of operating norms to help enterprises improve the sanitary environment, timely find the problems existing in the production process and improve them. In short, GMP requires pharmaceutical, food and other production enterprises to have good production equipment, reasonable production technology, perfect quality management and strict testing system to ensure that the final product quality (including food safety and hygiene) meets the requirements of laws and regulations.
HACCP stands for the critical control point of hazard analysis. It is a scientific, reasonable and systematic method to ensure the safety of food in the process of production, processing, manufacturing, preparation and eating. Hazard identification, assessment and control. But it does not represent an unacceptable threat to health. Identify the possible links in the food production process and take corresponding control measures to prevent the occurrence of harm. By monitoring and controlling every step of the processing process, the possibility of injury is reduced.
In HACCP, there are seven principles as the basis for implementing the system. They are
1 Conduct hazard analysis;
2 Determination of critical control points (CCPs), CCP is a step to implement control at key points. It is of great significance to prevent or eliminate food safety risks or reduce them to an acceptable level;
3. Determine the key limiting factors (one key factor can meet a CCP standard);
4. Establish a system for monitoring key control points;
5 When monitoring shows that CCP is out of control, take operable corrective measures;
6. Establish confirmation procedures to ensure the effective operation of HACCP system;
7. Establish and file implementation records related to all procedures and these principles.
What qualifications do food production enterprises need? What qualifications do health food manufacturers need? Food production requires food production license, and health food requires health food approval certificate.
Can blood products collected by blood stations be used as raw plasma? At present, China can't use donated blood to extract plasma. At present, all plasma is paid by the collection station.
The largest manufacturer of plastic products in China 100, please contact China Plastic Products Industry Association.
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Can blood products and vaccine products be commissioned? Hello! Article 28 of the Measures for the Supervision and Administration of Pharmaceutical Production stipulates: blood products, vaccine products and the State Food and Drug Administration of the United States.