Production process self-defined design method of medicaments

Abstract

The invention provides a production process self-defined design method of medicaments, which allows an enterprise to define a production process according with the actual condition according to a condition of a self production formulation by using a production process self-defined method, resolves the production process, acquires actual production data, compares the production data with a process standard, generates an early warning when an abnormity or a non-standard condition is discovered, and informs related personnel to achieve a basically all-purpose function of medicament production supervision. The production process self-defined design method comprises the following steps of: (1) customizing a model according to the production process; (2) self-defining a tool by a medicament production process; (3) performing quality point resolution on a customized process; (4) performing comparison and analysis on the actually acquired production data and a process-defined quality standard; and (5) performing pre-warning information on problematic production data generated by the comparison and the analysis.

Description

technical field [0001] The invention relates to an enterprise computer system management technology, in particular to an off-site supervision technology for pharmaceutical production using a computer to customize the key quality points of the general pharmaceutical production process to achieve comparison between static key point standards and dynamic production data Yes, to achieve the purpose of supervising drug production. Background technique [0002] At present, there are still some outstanding problems and weak links in the domestic drug production monitoring work, which lead to frequent occurrence of drug injury incidents. It is necessary to realize the off-site supervision of drug production by means of information technology and improve the supervision efficiency. It is of great significance to effectively ensure the quality of drug production, ensure the safety of drug use by the public, and maintain the harmonious development of society from the source of drug pro...

AI Technical Summary

Problems solved by technology

[0006] It is no problem for a single enterprise to realize the supervision of its own dosage forms, but it is very difficult for the national drug regulatory department to realize the production quality supervision of all enterprises or multiple dosage form manufacturers within its jurisdiction.

It requires a lot of manpower and material resources to research and develop one by one, and the cost and investment required are unimaginable