Why is GMP in pharmaceutical factory?

The purpose of GMP implementation is as follows:

GMP is a system to ensure the continuous production of drugs under specified quality. This is done to minimize the risk of substandard 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 1 May 19991date, the manufacturers of new drugs of Category III, IV and V 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 certificates before issuing the License for Pharmaceutical Production Enterprises. ? Within the prescribed time limit, enterprises that have not obtained the GMP certificate for drugs shall not renew the License for Pharmaceutical Production Enterprises. 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 the hidden dangers such as pollution, confusion and mistakes in drug production, which cannot be completely controlled only by the inspection of finished products.

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 uniformity 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 pharmaceutical production are strengthened, and the quality management level of enterprises is promoted.

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. Firstly, the cleanliness requirements of sterile preparations were adjusted. In order to ensure the quality and safety of sterile drugs, the new version of GMP adopted the latest grading standards of A, B, C and D of WHO and EU in the appendix of sterile drugs, and put forward specific requirements for the cleanliness level of sterile drug production.

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

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