GMP stipulates that there are two processes to be managed:
1. Pharmaceutical business processes that directly affect the quality of drugs: including the audit of first-class enterprises, drug procurement (audit of first-class varieties), acceptance, storage, maintenance, outbound review, sales, transportation, return, controlled management of unqualified drugs, controlled management of special drugs, etc.
Two, in order to ensure that the work of each stage of the drug quality ring can be done better, some support processes, organizations, personnel, information, facilities and equipment, rules and regulations, quality management activities records and internal audit of quality management system and other management processes.
GMP interpretation
GMP standard (Good Manufacturing Practice) is a system to ensure the continuous production of drugs under specified quality. It is to minimize the risk of unqualified drugs in the production process. GMP covers all aspects of requirements, from workshop to ground, equipment, personnel and training, hygiene, air and water purification, production and documentation. "GMP" is the abbreviation of English Good Manufacturing Practice, which means "product quality management standard" or "good manufacturing practice" in Chinese. It is an independent management system, paying special attention to product quality and health and safety in the production process.
GMP standard 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 a word, GMP requires production enterprises to have good production equipment, reasonable production technology, perfect quality management and strict testing system to ensure that the quality of final products (including food safety and hygiene) meets the requirements of laws and regulations.
The content specified by GMP is the most basic condition that pharmaceutical processing enterprises must meet.