GMP 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.

The main purpose of formulating and implementing GMP is to protect the interests of consumers and ensure people to use drugs safely and effectively; At the same time, it is also to protect pharmaceutical production enterprises, so that they can have laws and rules to follow.

The significance of implementing GMP is as follows:

1, which is beneficial to the development of new drugs and generic drugs. According to the regulations, since May 1 Kloc-0/99, the production enterprises of the third, fourth and fifth kinds of new drugs accepted by the State Administration of Pharmaceutical Products must obtain the GMP certificate of the corresponding dosage form or workshop before they can handle the production approval number according to the relevant regulations.

2, is conducive to the renewal of the "drug production enterprise license". Newly established pharmaceutical production enterprises must pass GMP certification and obtain GMP certificate before issuing the License for Pharmaceutical Production Enterprises. ? Within the prescribed time limit, an enterprise that has not obtained a GMP certificate for drugs shall not renew the Pharmaceutical Production Enterprise License. This means that the survival of enterprises is seriously threatened.

3, is conducive to improve the reputation of enterprises and products, improve competitiveness. Because all enterprises or workshops that have passed GMP certification have issued GMP certificates and published announcements in relevant newspapers, the relevant contents that have passed GMP certification can also be applied to the promotion of enterprises and products. This will inevitably further improve the image and reputation of enterprises (workshops), improve market competitiveness and occupy a larger market.

4, is conducive to improving the level of scientific management, promoting the quality of enterprise personnel and enhance quality awareness, to ensure the quality of drugs. GMP management is a scientific and advanced management method. Its biggest feature is that it attaches importance to both the result and the process. The content of GMP is mainly to eliminate hidden dangers in drug production, such as pollution, confusion, errors, etc., which cannot be completely controlled by finished product inspection alone.

Extended data:

Characteristics of GMP

The new GMP terms are more specific, instructive and operable; The regulations on production conditions and management system are more comprehensive and specific, which further ensures the safety, stability and unity of drug quality from the production link.

The characteristics of the new version of drug GMP are firstly reflected in strengthening the requirements for software. First, the quality management system of pharmaceutical production has been strengthened, and the requirements for enterprise quality management software have been greatly improved. The requirements for building an effective quality management system are refined, the control and management of key links in drug production are strengthened, and the quality management level of enterprises is improved.

The second is to comprehensively strengthen the quality requirements of employees. The provisions and contents of quality requirements for personnel engaged in drug production quality management have been added, and the responsibilities have been further clarified.

In terms of hardware requirements, the new GMP has improved the standards of some production conditions. First, the cleanliness requirements of sterile preparations were adjusted. In order to ensure the quality and safety of sterile drugs, the new GMP adopts the latest grading standards of A, B, C and D of WHO and EU in the appendix of sterile drugs, and puts forward specific requirements for the cleanliness level of sterile drug production.

The requirements for online monitoring have been increased, especially for static and dynamic monitoring of suspended particles in the production environment, and detailed regulations have been made for monitoring of planktonic bacteria, settling bacteria (microorganisms in the production environment) and surface microorganisms.

In addition, the requirements for equipment and facilities have also increased. The design and layout requirements of factory facilities are divided into production area, storage area, quality control area and auxiliary area respectively; Specific provisions are also made on the design and installation, maintenance and repair, use, cleaning, state identification and calibration of equipment.

References:

Baidu encyclopedia -GMP