Including institutions and personnel, factories and facilities, equipment and instruments, hygiene and cleanliness management, document and record management, material and product control, production management, quality management, delivery and recall management. It involves all aspects of drug production and quality, and emphasizes the quality management of the whole production process to ensure the production of high-quality drugs.
Extended data:
Characteristics of GMP
1, principle
GMP only stipulates the objectives to be achieved by quality or quality management, but does not list the solutions to achieve these objectives. The methods and means to meet GMP requirements are diversified, and enterprises have autonomy and selectivity. Different pharmaceutical manufacturers can choose the most suitable method or way to achieve GMP standards according to their own products or product process characteristics.
2. Foundation
GMP is the lowest standard to ensure the quality of drug production. In other words, GMP is the most basic standard for drug production and quality management, not the highest and best standard, and even less the unattainable standard. It is impossible for GMP in any country to regard a production and quality management standard that can only be achieved by a few pharmaceutical manufacturers as a mandatory requirement of the whole industry.