Through GMP and GSP, look at the identification and prevention and control of over-temperature risk in pharmaceutical cold chain logistics

As a branch of the logistics industry, the medical cold chain specifically refers to a systematic project from producer to user of refrigerated drug entities for the purpose of preventing, diagnosing and treating people’s diseases, including A series of links including its production, transportation, storage and use. As the scale of my country's pharmaceutical circulation continues to increase, the development of the pharmaceutical cold chain, which was originally a supplement to the pharmaceutical circulation supply chain, has attracted more attention, and the country has also issued a series of related documents. Among them, 'Good Manufacturing Practice for Pharmaceuticals' is referred to as GMP, and 'Good Manufacturing Practices for Pharmaceutical Business' is referred to as GSP.

1. GMP

GMP refers to the quality of the personnel responsible for drug quality control and production operators to the drug production plant, facilities, equipment, production management, process hygiene, and material management A scientific management system for quality control, storage and sales of finished products to ensure drug quality. The basic point is to ensure the quality of medicines and prevent errors, confusion, contamination and cross-contamination.

The basic content includes the establishment of pharmaceutical companies and the quality of personnel, plants, facilities, equipment, materials, hygiene, verification, documentation, production management, quality management, product sales and recovery, complaints and adverse reaction reports, etc. . GMP applies to the whole process of drug production and the key processes that affect the quality of finished products in the production of raw materials. The main content can be summarized in the following aspects, including: suitable production plants, facilities, equipment; suitable raw materials and packaging materials; proven production methods and production processes; well-trained production personnel and management personnel; Perfect after-sales service; strict management system.

The new version of GMP has greatly improved the requirements for aseptic production. Specifically, the environmental control is basically consistent with international requirements; the international general zoning and control standards are adopted for laminar flow and key operation control areas; the advanced isolation operation technology and blowing and potting technology are included in the specification for the first time, ensuring sterility Level, sterility inspection, etc. put forward detailed and specific requirements; the requirements for sterility verification are fully consistent with internationally. Starting from March 1, 2011, new drug manufacturing enterprises and new (renovated or expanded) workshops of drug manufacturing enterprises shall meet the requirements of the new version of the drug GMP. Existing pharmaceutical manufacturers will be given a transition period of no more than 5 years, and according to the degree of product risk, meet the requirements of the new version of the drug GMP in stages by category.

Second, GSP

GSP is the abbreviation of 'Pharmaceutical Business Quality Management Regulations'. It was issued by Order No. 20 of the State Drug Administration in 2000 and came into effect on July 1 of the same year.

GSP, as the basic guidelines for the quality management of pharmaceutical business in my country, contains the requirements of the advanced quality management regulations for pharmaceutical commercial enterprises, such as purchase management, acceptance management, storage and maintenance management, sales and after-sales service management Wait. Therefore, the implementation of GSP will better promote the operation and management of pharmaceutical companies in accordance with the law to ensure the quality of the distribution of drugs, protect the legitimate rights and interests of users and consumers, and the safe and effective use of drugs by the people.

Implementing GSP and striving to realize the internationalization of my country’s pharmaceutical commercial quality management and quality assurance standards will enable my country’s pharmaceuticals to enter the world market as soon as possible, promote international pharmaceutical exchanges, improve the economic efficiency of enterprises, and enable pharmaceutical business enterprises Obtained considerable development.

The most serious aspect of GSP as an ideological system is 'quality first'. This requires companies to take quality as the primary issue in any business activities to ensure the quality of drugs. It is conducive to the development of enterprises, promotes changes in business thinking and business organization structure, and promotes the use of advanced science and technology to ensure the safety and reliability of medicines.

The implementation of GSP is to further accelerate the adjustment of my country's pharmaceutical industry structure, enlarge and strengthen a batch of pharmaceutical companies, raise the threshold of market access for the pharmaceutical industry, and improve the intensification, scale and integration of enterprises Competitiveness, a major decision made to meet the requirements of the development of the situation after my country's entry into the WTO, is also the only way for my country's drug circulation reform.

Medicine and drug safety are directly related to people's livelihood and social stability. At the same time, it puts forward higher requirements for my country's logistics supply chain, especially cold chain logistics. The cold chain pharmaceutical product market continues to expand, and the quality management of pharmaceutical cold chain logistics is facing unprecedented opportunities and challenges. The development of pharmaceutical cold chain logistics still has a long way to go.