Gmp Equipment Management Information System Development

The drug is special merchandise, so it's quality is most important for pharmacy. In order that the pharmacy can accord with international standard and ensure the quality of drug, the pharmacy was required to get GMP (Good Manufacture Practice) certificate and carry out GMP management by China government. It is not allowed to produce any drugs if the pharmacy don't get GMP certificate or it don't carry out GMP, so it can guarantee the drug's quality at all.Equipment is one of absolutely necessarily elements in pharmacy, it is tools or carrier during production procedure of drugs, The quality of drugs more depends on supporting of equipment system, So GMP has unambiguous regulation and requirement for using, maintenance and management of equipment.The equipment and system which Involved in production of drug is multifarious, such as cleanroom air handling system and some process equipment etc. All the things must be true of GMP's regulations and requirements, So in order to satisfy GMP criterion, it has to carry out stronger management in each aspect, such as documentation, daily running, maintenance & repair, inspecting & validation and personal management etc.At present, equipment management still use traditional mode in many pharmacies, they use behindhand mode and method such as handwrought management and huger paper record, it cause that each aspect of equipment management is isolated, can't integrate together, and can't find out status of equipment in time, it also can't satisfy requirement of GMP. With carrying out of GMP criterion the disadvantages of traditional management are showing.Under this situation, advance management mode and method must be adopted for pharmacy's equipment management. So we base on practice situation of our institute, and take advantage of computer technology, database and UML(Unified Modeling Language) , according to the GMP criterion and regulation of SOP(standard operating procedures) have developed "GMP equipment management information system" application software which is facing maintenance & repair people, equipment managerand commander of production. The system is composed of four subsystems: (1) General Information Management Subsystem. It is used for systemic management of general equipment information, spare parts information, staff information and GMP's document. (2) Equipment Management Subsystem. It can be used to manage equipment daily running, maintenance & repair, inspecting & validation. (3) Information Query Subsystem. Equipment manager can quickly query the equipment information convenient, so that it can provides equipment status for management of equipment and planning production. (4) Security Management Subsystem. It can ensure security and stabilization of the Whole system, such as backup and restore database.The system was established by using C/S(client/server)system structure mode, SQL Server 2000 as database and Delphi 7.0 as program tool. UML (Unified Modeling Language) was used for Requirement analyze and system designing. The system achieve requirement of GMP GMP criterion. The user can quickly, easily, exactly find out status of equipment, and carry out management of equipment.The system already used in practice, it is proved the system contributes to heightening work efficiency and improving work quality for manager of equipment. It also establish foundation for developing and improving powerful intelligentized GMP equipment management information system.