A drug quality control analysis system based on quality management practice data tracking

Abstract

The invention belongs to the technical field of drug quality control, and specifically discloses a drug quality control analysis system based on quality management specification data tracking, including a tablet production process flow statistics module, a production process flow production monitoring terminal setting module, and a production process flow production operation parameter collection Module, production process flow production environment parameter collection module, tablet finished product appearance shape parameter collection module, quality modeling analysis module, production quality database and quality control processing terminal, through the tablet production process operation standard quality coefficient in the tablet production process , The appropriate quality coefficient of the tablet production environment and the quality coefficient of the appearance of the finished tablet are analyzed and counted, so as to comprehensively judge whether the production quality of the tablet is qualified, and when the judgment result is that the production quality of the tablet is unqualified, track the cause of the failure and effectively make up for it. The deficiencies in the current quality analysis methods for tablet production are overcome.

Description

technical field [0001] The invention belongs to the technical field of drug quality control, in particular relates to a drug production quality control technology, specifically a drug quality control analysis system based on quality management specification data tracking. Background technique [0002] As a special commodity, medicine is closely related to human health. The importance and particularity of medicines determine that a strict quality management system must be established for quality control in the whole process of production, circulation and use of medicines; Whether the production quality is qualified directly determines whether the drug can be used in the following circulation steps. It can be seen that the production quality control of the drug is the key to the quality control of the entire drug. [0003] In all kinds of medicines, tablets are the most commonly used medicines, so the present invention takes tablets as an example to analyze the production qual...

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Problems solved by technology

[0003] In all kinds of medicines, tablets are the most commonly used medicines, so the present invention takes tablets as an example to analyze the production quality control of tablets; at present, the production quality analysis of tablets is basically performed on the appearance of finished tablets after the production of tablets is finished. Quality analysis, from which to judge whether the production quality of the tablet is qualified, this kind of judgment method is too one-sided; because the production of the tablet is not accomplished overnight, but is produced through the corresponding production process in a certain production environment, the production environment Both the production process and the production process are necessary conditions for tablet production, and will affect the production quality of the tablet; when the tablet production environment is not suitable or the tablet production process is not standardized, even if the appearance and quality of the finished tablet meet the requirements, it cannot represent The production quality of the tablet is qualified; from another perspective, the quality of the standardized operation of the tablet production process, the suitable quality of the tablet production environment, and the quality of the appearance and shape of the finished tablet comprehensively determine the production quality of the tablet. , The suitability of the tablet production environment for quality analysis, when it is determined that the production quality of the tablet is unqualified, the cause of the unqualified production quality cannot be traced; it can be seen that the current analysis method of the production quality of the tablet is difficult to determine whether the quality of the tablet production is qualified. On the other hand, it is impossible to trace the reasons for the unqualified production quality of the tablets

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