Introduction to GMP Certification

GMP "is an abbreviation for Good Manufacturing Practice in English, which means" Good Manufacturing Practice "or" Good Manufacturing Standards "in Chinese. It is an autonomous management system that places special emphasis on product quality and hygiene safety during the manufacturing process. It is a set of mandatory standards applicable to industries such as pharmaceuticals and food, requiring enterprises to meet hygiene and quality requirements in accordance with relevant national regulations in terms of raw materials, personnel, facilities and equipment, production processes, packaging and transportation, quality control, etc. It forms a set of operable operating norms to help enterprises improve their hygiene environment, timely discover problems in the production process, and make improvements. On July 11, 1995, the Chinese Ministry of Health issued Wei Yao Fa (1995) No. 35; Notice on Carrying out Drug GMP Certification Work;. Drug GMP certification is a system in which the country conducts GMP supervision and inspection on drug production enterprises (workshops) and drug varieties in accordance with the law and obtains recognition. Although the international concept of drugs includes veterinary drugs, only a few countries such as China and Australia separate human use GMP and veterinary drug GMP. The GMP certification of drugs is divided into two levels: national and provincial. According to the Implementation Regulations of the Drug Administration Law of the People's Republic of China, the drug supervision and management departments of the people's governments at or above the provincial level shall organize the certification work of drug production enterprises in accordance with the "Good Manufacturing Practice for Drugs" and the implementation methods and steps stipulated by the drug supervision and management department of the State Council; Those who comply with the "Good Manufacturing Practice for Drugs" will be issued a certification certificate. Among them, the certification work of pharmaceutical production enterprises that produce injections, radioactive drugs, and biological products specified by the State Council's drug regulatory department is the responsibility of the State Council's drug regulatory department.

The purpose of GMP certification standards is to:

1. Prevent mixing between different drugs or their components;

2. Prevent cross contamination caused by other drugs or substances; Prevent errors and distortions in measurement and information transmission;

3. Prevent accidents that result in missing any inspection steps;

4. Prevent violations and illegal incidents such as arbitrary operations, non-compliance with standards, and low limit feeding;

5. The main purpose of formulating and implementing GMP 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, implementing GMP is a responsibility entrusted to the pharmaceutical industry by the government and laws, and it is also a requirement for China to implement a drug quality assurance system after joining the WTO.