CN102156911A - Non-scene supervision method for drug production - Google Patents

Abstract

Translated fromChinese

本发明提供一种药品生产非现场监管方法，是对药品生产企业生产过程数据进行分析时，及时反映生产企业生产过程的真实问题，给分析产品质量问题和实施监管提供最有效的依据。非现场监管平台是以信息化手段有效实施对药品生产过程的动态监管，非现场监管平台涵盖两大监管平台：视频监管平台和数字监管平台，通过数据监控和视频监控，提高生产质量。

The invention provides an off-site supervision method for pharmaceutical production, which is to timely reflect the real problems in the production process of the pharmaceutical production enterprise when analyzing the production process data of the pharmaceutical production enterprise, and provide the most effective basis for analyzing product quality problems and implementing supervision. The off-site supervision platform effectively implements the dynamic supervision of the drug production process by means of information technology. The off-site supervision platform covers two major supervision platforms: a video supervision platform and a digital supervision platform. Through data monitoring and video monitoring, the production quality is improved.

Description

The non-at-scene monitoring and managing method of a kind of pharmaceutical production

Technical field

The present invention relates to a kind of Computer Applied Technology field, the non-at-scene monitoring and managing method of specifically a kind of pharmaceutical production.

Background technology

Drug safety is the focal issue of whole society's extensive concern concerning body health of people and life security.Pharmaceutical production is the source of product quality, realizes the dynamic supervision of beginning of production is had crucial effects for ensuring drug quality.

Various places pharmaceutical producing enterprise quantity is many, distribution is wide, and the supervision strength of supervision department is limited, the supervision coverage rate is little, can't strictness hold drug quality, is the difficult problem of food and medicine Surveillance Authority supervision always.Phenomenons such as because pharmaceutical producing enterprise management and GMP executive level are uneven, strictness organizes the production behavior to happen occasionally by the GMP regulation, still exists part enterprise not have correctly to handle the relation of business economic benefit and social benefit, and responsibility consciousness is thin; Quality control of pharmaceutical production means shortcoming, product quality do not ensure, are the difficult points of food and medicine supervision supervision, are difficult to find the entry of supervision always.Primary monitor infrastructure and technical supervision condition relatively lag behind, and the supervisor is few, supervision information is not smooth etc., also is the bottleneck that restricts supervisory efficiency and quality at present.Non-at-scene supervising platform can be with the effective dynamic supervision of implementing drug production process of information-based means.

Summary of the invention

The purpose of this invention is to provide the method that a kind of digital collection and video cooperatively interact,, guarantee the quality of production by analyzing and report to the police the timely problem of finding in the production.

The objective of the invention is to realize in the following manner, the present invention relates in the non-at-scene supervision of pharmaceutical production field, when pharmaceutical producing enterprise's production process data is analyzed, the true problem of the manufacturing enterprise of reflection in time production run, giving the analytic product quality problems and implementing supervision provides the most effective foundation.

Non-at-scene supervising platform is with the effective dynamic supervision of implementing drug production process of information-based means, non-at-scene supervising platform is contained two big supervising platforms: video supervising platform and digital supervising platform, by data monitoring and video monitoring, improve the quality of production, concrete steps are as follows:

1) checking of data can be carried out from bath manufacturing records, product sequence, production equipment, a plurality of angles of collecting device, the type of data is divided into two kinds of service data and result datas, the operational process of service data record production equipment, whether normally result data is the analysis to service data, be judgment device operational process foundation;

2) after the on-line data acquisition terminal is obtained each production equipment service data in real time, can in time analyze the data of being gathered, if it is no problem to analyze, then equipment operating data is transmitted at once, if do not meet the requirement of GMP related specifications by analyzing back discovering device operation, then produce the early warning data immediately, and early warning data and process data are transmitted.

Beneficial effect of the present invention

1) each on-line data acquisition is analyzed, can be improved the quality of production.

2) can check relevant data at any time and it is made analysis from each operation of bath manufacturing records.

3) can monitor the condition of production of key post from video monitoring system.

Description of drawings

Fig. 1 is the monitoring management system structural representation;

Embodiment

Explain below with reference to Figure of description method of the present invention being done.

The step content comprises

1) sets up pharmaceutical producing enterprise's base profile, the various data in the production run are gathered,, improve the quality of production by data monitoring and video monitoring.

2) the on-line data acquisition terminal is in time analyzed the data of being gathered, if do not meet dependency rule, then produces early warning immediately, makes things convenient for enterprise personnel to take measures also to make things convenient for simultaneously to supervise.

3) checking of data can be carried out from a plurality of angles such as bath manufacturing records, product sequence, production equipment, collecting devices, pass through which kind of mode as opinion, the type of data all is divided into two kinds of service data and result datas, the operational process of service data record production equipment, whether normally result data is the analysis to service data, be judgment device operational process foundation.

4) the on-line data acquisition terminal can in time be analyzed the data of being gathered after obtaining each production equipment service data in real time, if it is no problem to analyze, then equipment operating data is transmitted at once, if do not meet the requirement of GMP related specifications by analyzing back discovering device operation, then produce the early warning data immediately, and early warning data and process data are transmitted.

Claims (1)

Translated fromChinese

1.一种药品生产非现场监管方法，非现场监管平台是以信息化手段有效实施对药品生产过程的动态监管，非现场监管平台涵盖两大监管平台：视频监管平台和数字监管平台，其特征在于数据真实性保证方法，其特征在于，通过数据监控和视频监控，提高生产质量，具体步骤如下：1. An off-site supervision method for drug production. The off-site supervision platform effectively implements dynamic supervision of the drug production process by means of information technology. The off-site supervision platform covers two major supervision platforms: a video supervision platform and a digital supervision platform. Its characteristics The data authenticity guarantee method is characterized in that the production quality is improved through data monitoring and video monitoring, and the specific steps are as follows:1)建立药品生产企业基础档案，对生产过程中的各种数据进行采集，通过数据监控和视频监控，提高生产质量；1) Establish the basic files of pharmaceutical production enterprises, collect various data in the production process, and improve production quality through data monitoring and video monitoring;2)在线数据采集终端对所采集的数据及时进行分析，如果不符合相关规则，则立即产生预警，方便企业人员采取措施同时也方便监管；2) The online data collection terminal analyzes the collected data in a timely manner. If it does not meet the relevant rules, it will immediately generate an early warning, which is convenient for enterprise personnel to take measures and also facilitates supervision;3)数据的查看是从批生产记录、产品工序、生产设备、采集设备多个角度进行，如论通过哪种方式，数据的类型都分为运行数据和结果数据两种，运行数据记录生产设备的运行过程，结果数据是对运行数据的分析，是判断设备运行过程是否正常的依据；3) The data is viewed from the perspectives of batch production records, product procedures, production equipment, and collection equipment. Regardless of the method, the data types are divided into two types: operation data and result data. Operation data records production equipment The operation process, the result data is the analysis of the operation data, and is the basis for judging whether the operation process of the equipment is normal;4)在线数据采集终端实时获取各生产设备运行数据后会及时对所采集的数据进行分析，如果分析没有问题，则把设备运行数据立刻进行传输，如果通过分析后发现设备运行不符合GMP相关规范要求，则立即产生预警数据，并对预警数据和过程数据进行传输。4) The online data collection terminal will analyze the collected data in real time after obtaining the operation data of each production equipment in real time. If there is no problem in the analysis, the equipment operation data will be transmitted immediately. If the equipment operation is found to be incompatible with the relevant GMP regulations after analysis If required, the early warning data will be generated immediately, and the early warning data and process data will be transmitted.

Images