Daily Record (Invoicing)

Training (at least once a year)

Evaluation (management system, quality policy, near-quality review, etc.). )

Document collection and arrangement (first camp, customer qualification)

Information collection (adverse reactions, complaints, etc.). )

Warehouse management (partitioned storage tanks, acceptance and maintenance rooms)

Which department issued the food and drug quality inspection report?

At present, the legal food and drug quality inspection and testing institution in China is the Food and Drug Inspection Institute. The three-level institutions of China's food and drug inspection institute are: China Food and Drug Inspection Institute, food and drug inspection institutes of all provinces and municipalities directly under the Central Government (including a customs food and drug inspection institute), and food and drug inspection institutes of all cities. Therefore, food and drug quality inspection reports should be issued by food and drug inspection offices at all levels to have legal effect.

China Food and Drug Inspection Institute, directly affiliated to China Food and Drug Administration, is the statutory national inspection and arbitration institution with the highest quality of food, health care products, medicines, biological products, cosmetics and medical devices.

Subordinate institutions of China Food and Drug Inspection Institute: Institute of Food Cosmetics, Institute of Traditional Chinese Medicine, Institute of Chemical Drugs, Institute of Biological Products, Institute of Medical Devices, Institute of Packaging Materials and Pharmaceutical Accessories, Institute of Experimental Animal Resources, Institute of Reference Materials and Standardization, Institute of Food and Drug Safety Evaluation, Institute of Food and Drug Technical Supervision, Institute of Medical Device Standard Management, etc.

Food and drug inspection offices of all provinces and municipalities directly under the Central Government (including 10 customs food and drug inspection offices) and food and drug inspection offices of all cities. Establish relevant departments.

Drug quality standards are the legal basis that relevant departments should follow.

(1) We must adhere to the principle of "quality first, fully embody the principle of" safety, effectiveness, advanced technology and economy ",adopt advanced standards as far as possible, and make standards play a role in promoting quality improvement, ensuring priority development and promoting foreign trade. (2) We should investigate the factors affecting the quality of drugs from the aspects of production, circulation and use, formulate targeted testing items, and effectively strengthen the control of the internal quality of drugs. (3) The selection of inspection method should be based on the principle of "accuracy, sensitivity, simplicity and rapidity", emphasizing the applicability of the method, and paying attention to absorbing domestic scientific research achievements and foreign advanced experience; We should not only consider the actual situation in China, but also reflect the application and development of new technologies to further improve and improve the detection level. For some antibiotics, biochemical drugs and varieties that must be bioassayed, chemical and instrumental analysis methods can be used to control their purity, and the bioassay methods can be continuously improved. (4) The limits specified in the standard should be closely combined with the actual situation to ensure the quality of drugs in the process of production, storage, sale and use, and may fully meet the requirements. In the process of formulating drug quality standards, there are some specific provisions on some details.

Which department does the Food and Drug Administration belong to? Health bureau?

Judging from the composition of the State Council, the Food and Drug Administration was originally a part of the State Council. According to the Food Safety Law of People's Republic of China (PRC), its functions have been adjusted to become a subordinate institution of the Ministry of Health, that is, a secondary department, parallel to the Administration of Traditional Chinese Medicine of the Ministry of Health. This management system is the same at the provincial level. Vertical management is now resumed below the provincial level, that is, the Food and Drug Administration and the Health Bureau are at the same level.

What are the health administrative departments, quality supervision departments, industrial and commercial administrative departments and food and drug supervision departments respectively? How to distinguish?

I think you are asking about the function of food segmentation management?

Previously, the health administrative department supervised and managed the restaurants in public places, including the setting of kitchens and the sanitation of the whole public place. (Different regions will have different regulatory settings, just like Shenzhen's example of merging the Industrial and Commercial Bureau, the Quality Supervision Bureau and the Health Supervision Bureau into the Market Supervision Bureau. )

Quality supervision department is the supervision and management department of food production and processing enterprises, including all kinds of food production enterprises. The main means of supervision is to supervise through physical and chemical experiments or microbial experiments.

The administrative department for industry and commerce supervises and manages the food circulating in the market, mainly including the food sold in supermarkets and shops, so the products supervised by the quality supervision department and the industrial and commercial department also have cross-management.

However, the newly established US Food and Drug Administration unified all the above foods into one department for supervision and management, and included all food-related links.

Which department should audit the quality of drugs? Production department or quality management department?

Quality department! At the same time, there are relevant explanations in ICH Q7, which can be reviewed one by one according to the GMP regulations of China.

What industry does health care products belong to? Which industry does it belong to, Food and Drug Administration or Quality Supervision Bureau?

Health products are under the jurisdiction of the Food and Drug Administration.