US QSR 820

QSR 820 in the United States requires the development of systematic and standardized procedures in institutions, personnel, factories, facilities and equipment, hygiene, verification, documentation, production management, quality management, product sales and recycling, complaint and adverse reaction reporting, self inspection, and other aspects. By implementing these procedures, a common goal can be achieved:
Prevent mixing between different drugs or their components;
Prevent cross contamination caused by other drugs or substances;
Prevent errors and distortion in measurement and information transmission;
Prevent accidents that omit any production and inspection steps;
Prevent illegal accidents such as arbitrary operations, non-compliance with standards, and low limit feeding;

The main purpose of formulating and implementing QSR 820 in the United States is to protect the interests of consumers and ensure the safety and effectiveness of medication; At the same time, it is also to protect pharmaceutical production enterprises and provide them with laws and regulations to follow; In addition, the implementation of QSR 820 is a responsibility entrusted to the pharmaceutical industry by the government and laws, and it is also a necessity for China to implement a drug quality assurance system after joining the WTO - because if drug production enterprises do not pass the QSR 820 inspection in the United States, they may be excluded from the technical barriers of international trade.

From this, it can be seen that the implementation of QSR 820 in the United States is not only a concrete manifestation of the high sense of responsibility of pharmaceutical production enterprises for the safety and effectiveness of people's medication, but also an important symbol of enterprises and an important guarantee of the competitiveness of enterprises and products. It is a prerequisite for aligning with international standards and allowing pharmaceutical products to enter the international market. Therefore, it can be said that the implementation of QSR 820 is the foundation for the survival and development of pharmaceutical production enterprises, and through QSR 820, it is the "access certificate" for products to reach the world.

The main international standards for health food are:
1. QSR 820: QSR is the abbreviation for Quality System Regulations. 820 actually refers to CFR 21 Part 820, which is the relevant requirement for medical device quality management systems in FDA regulations. QSR820 is not an isolated requirement, its requirements are closely related to other parts such as Part 803 and Part 807. The requirements of QSR820 and ISO13485 are partially similar, but there are also significant differences.
2. FDA is the abbreviation for the National Food and Drug Administration of the United States. FDA certification is a passport (minimum threshold) for all health products, drugs, and nutritional products worldwide to be sold in the European and North American markets. FDA certification requires 20-30000 people, 3-7 years of clinical testing, costs approximately $350 million, and requires 143 key testing procedures to obtain certification