Contents of GMP Specifications

The content of GMP specification includes both hardware and software. Hardware refers to the material conditions that must be fulfilled in order to ensure the correct implementation of specifications and prevent product contamination by production enterprises, including plant facilities, production equipment, testing equipment, etc. In terms of software, it refers to the management system, management organization, management standards, process regulations, record reports, etc. formulated to ensure the normal operation of hardware and prevent pollution caused by errors or human errors. Kenwei has rich experience in GMP whole plant planning. In the actual operation process, Kenwei's GMP workshop planners listed the following problems according to the problems encountered. In the implementation of GMP norms, attention should be paid to the following issues. (1) Strict requirements and careful planning of the logistics (raw materials, semi-finished products, finished products) and flow of people (operators, management personnel) in the workshop must be strictly required for the transformation of research parts. contamination of the final product. The factory building should be equipped with adequate use and reasonable layout of changing rooms, buffer rooms, logistics storage rooms, operation rooms, inspection rooms and other places. Indoor packaging production lines should be carefully and specialized in plane and three-dimensional layout design. The working equipment is in a reasonable direction and the interval is sufficient. The intermediate products are stored in an orderly manner, so that they can be adapted to the rhythm of the product line and avoid operational errors. Zhongshan Kenwei Precision Machinery has rich experience in GMP whole plant planning, especially in deoxidizer GMP whole plant planning and desiccant industry planning. There is only Zhongshan Kenwei in the world. Operating room air purification facilities are designed in strict GMP standards (cleanliness, ventilation times, etc.). According to the requirements of GMP, the air flow design is made to prevent the secondary flying of air dust particles and reduce the occurrence of air eddy currents. In order to prevent the infiltration of outdoor unclean air, the air pressure in the clean room must be effectively controlled to maintain a certain positive pressure. Effectively prevent cross-contamination of packaged products. Minimize the adverse effects of pollution sources such as dust, water vapor, microorganisms, and staff's clothes in the processing raw materials, strictly limit the production and packaging of products in different isolation areas, and avoid the production of different products in the same isolation area, and the handling of raw materials. It should also be done in a closed environment. (2) Effective control of product quality The purpose of the product quality assurance system is to make product production meet its final use requirements. Because drugs are directly related to the safety of users, there are strict requirements for their packaging. Drugs are strictly controlled special commodities in all countries in the world. At present, my country has implemented GMP certification and a classification management system for prescription drugs and non-prescription drugs. Pharmaceutical packaging design puts forward higher requirements.