CN118095842A - Supervision system and method for drug production - Google Patents

Abstract

The application relates to a supervision system and a supervision method for pharmaceutical production, wherein the system comprises: the enterprise terminal module is used for collecting medicine production data of medicine production enterprises, wherein the medicine production data comprise medicine finished product data, medicine intermediate data, medicine process yield data and medicine raw and auxiliary material data; the monitoring end module is used for acquiring the medicine production data of each medicine production enterprise acquired by the enterprise end module; and the black box module is used for providing algorithm analysis service and risk early warning service for the enterprise terminal module and responsibility tracing service and risk early warning service for the supervision terminal module according to the medicine production data. The application solves the problem of accurately controlling the medicines produced and processed by the medicine mechanized production enterprises, realizes the risk early warning based on the black box and related data in the medicine production process, and can accurately control the quality and safety of the medicines produced and processed by the medicine mechanized production enterprises.

Description

Supervision system and method for drug production

Technical Field

The application relates to the technical field of production management and control, in particular to a supervision system and method for drug production.

Background

The safety problem of the medicine production industry is related to the life health of people, and a medicine enterprise must establish a quality management system from the social responsibility and quality assurance of the medicine enterprise, and simultaneously establish a complete file and a quality assurance system to ensure the effective operation of the system.

The existing scheme generally records information on the medicine production flow and the circulation flow, namely, stores and records related data in the medicine production supervision process so as to realize traceability, and is difficult to realize accurate management and control of medicines produced and processed by a medicine mechanized production enterprise.

At present, no effective solution is proposed for accurately controlling medicines produced and processed by a pharmaceutical mechanized production enterprise in the related art.

Disclosure of Invention

The embodiment of the application provides a supervision system and a supervision method for drug production, which at least solve the problem of accurately managing and controlling drugs produced and processed by a drug mechanized production enterprise in the related technology.

In a first aspect, an embodiment of the present application provides a system for monitoring pharmaceutical production, the system including an enterprise-side module, a monitoring-side module, and a black box module;

The enterprise terminal module is used for collecting medicine production data of a medicine production enterprise, wherein the medicine production data comprise medicine finished product data, medicine intermediate data, medicine process yield data and medicine raw and auxiliary material data;

The supervision terminal module is used for acquiring the medicine production data of each medicine production enterprise acquired by the enterprise terminal module;

the black box module is used for providing algorithm analysis service and risk early warning service for the enterprise terminal module according to the drug production data; and providing responsibility tracing service and risk early warning service for the supervision terminal module according to the medicine production data.

In some embodiments, the black box module is configured to provide a product quality consistency analysis service, a dispersion analysis service, a similarity analysis service, and a product trend analysis service for the enterprise-side module according to the pharmaceutical product data.

In some embodiments, the black box module is configured to provide a production link stability analysis service, a similarity analysis service, and an intermediate trend analysis service for the enterprise-side module according to the pharmaceutical intermediate data.

In some embodiments, the black box module is configured to provide a production node yield deviation risk analysis service for the enterprise-side module according to the pharmaceutical process yield data.

In some embodiments, the black box module is configured to provide a similarity analysis service for the enterprise module according to the pharmaceutical raw material data.

In some embodiments, the black box module is configured to provide the enterprise-side module with basic information corresponding to a pharmaceutical manufacturing enterprise, where the basic information includes interface query information, log query information, data synchronization information, and detection report information.

In some embodiments, the black box module is configured to provide the supervision module with enterprise information of each pharmaceutical manufacturing enterprise, where the enterprise information includes product information, credit evaluation information, and industry distribution information.

In some embodiments, the black box module is configured to provide data storage services for the enterprise-side module and the supervision-side module, store the drug production data collected by the enterprise-side module, and store the drug production data obtained by the supervision-side module.

In a second aspect, an embodiment of the present application provides a method of supervising pharmaceutical production, the method being performed based on the system of any one of the first aspects, the method comprising:

acquiring medicine production data of a medicine production enterprise, wherein the medicine production data comprises medicine finished product data, medicine intermediate data, medicine process yield data and medicine raw and auxiliary material data;

And obtaining a medical analysis result through a preset analysis algorithm according to the medicine production data, wherein the medical analysis result is used for judging whether the medicine production enterprises have production risks or not.

In some embodiments, obtaining the medical analysis result by the preset analysis algorithm according to the drug production data comprises:

According to the medicine finished product data, a first medicine analysis result is obtained through a product quality consistency analysis algorithm, a dispersion analysis algorithm and a finished product trend analysis algorithm respectively;

according to the medical intermediate data, a second medical analysis result is obtained through a production link stability analysis algorithm and an intermediate trend analysis algorithm respectively;

Obtaining a third medical analysis result through a production node yield deviation risk analysis algorithm according to the medical process yield data;

according to the medicine raw and auxiliary material data, a fourth medicine analysis result is obtained through a raw and auxiliary material inspection analysis algorithm;

And obtaining a fifth medical analysis result through a similarity analysis algorithm according to the medical finished product data and the medical intermediate data.

Compared with the related art, the system and the method for supervising the production of the medicines provided by the embodiment of the application comprise an enterprise terminal module, a supervising terminal module and a black box module; the enterprise terminal module is used for collecting medicine production data of medicine production enterprises, wherein the medicine production data comprise medicine finished product data, medicine intermediate data, medicine process yield data and medicine raw and auxiliary material data; the monitoring end module is used for acquiring the medicine production data of each medicine production enterprise acquired by the enterprise end module; the black box module is used for providing algorithm analysis service and risk early warning service for the enterprise terminal module according to the medicine production data, and providing responsibility tracing service and risk early warning service for the supervision terminal module.

Drawings

The accompanying drawings, which are included to provide a further understanding of the application and are incorporated in and constitute a part of this specification, illustrate embodiments of the application and together with the description serve to explain the application and do not constitute a limitation on the application. In the drawings:

FIG. 1 is a block diagram of a pharmaceutical production monitoring system according to an embodiment of the present application;

FIG. 2 is a schematic diagram of a black box module according to an embodiment of the present application;

FIG. 3 is a hardware schematic of a black box module according to an embodiment of the application;

FIG. 4 is a schematic diagram of a hardware interface of a black box module according to an embodiment of the present application;

FIG. 5 is a flow chart of steps of a method of pharmaceutical production supervision according to an embodiment of the application;

Fig. 6 is a schematic diagram of an internal structure of an electronic device according to an embodiment of the present application.

The attached drawings are identified: 11. an enterprise terminal module; 12. a supervision terminal module; 13. and a black box module.

Detailed Description

The present application will be described and illustrated with reference to the accompanying drawings and examples in order to make the objects, technical solutions and advantages of the present application more apparent. It should be understood that the specific embodiments described herein are for purposes of illustration only and are not intended to limit the scope of the application. All other embodiments, which can be made by a person of ordinary skill in the art based on the embodiments provided by the present application without making any inventive effort, are intended to fall within the scope of the present application.

It is apparent that the drawings in the following description are only some examples or embodiments of the present application, and it is possible for those of ordinary skill in the art to apply the present application to other similar situations according to these drawings without inventive effort. Moreover, it should be appreciated that while such a development effort might be complex and lengthy, it would nevertheless be a routine undertaking of design, fabrication, or manufacture for those of ordinary skill having the benefit of this disclosure, and thus should not be construed as having the benefit of this disclosure.

Reference in the specification to "an embodiment" means that a particular feature, structure, or characteristic described in connection with the embodiment may be included in at least one embodiment of the application. The appearances of such phrases in various places in the specification are not necessarily all referring to the same embodiment, nor are separate or alternative embodiments mutually exclusive of other embodiments. It is to be expressly and implicitly understood by those of ordinary skill in the art that the described embodiments of the application can be combined with other embodiments without conflict.

Unless defined otherwise, technical or scientific terms used herein should be given the ordinary meaning as understood by one of ordinary skill in the art to which this application belongs. The terms "a," "an," "the," and similar referents in the context of the application are not to be construed as limiting the quantity, but rather as singular or plural. The terms "comprising," "including," "having," and any variations thereof, are intended to cover a non-exclusive inclusion; for example, a process, method, system, article, or apparatus that comprises a list of steps or modules (elements) is not limited to only those steps or elements but may include other steps or elements not expressly listed or inherent to such process, method, article, or apparatus. The terms "connected," "coupled," and the like in connection with the present application are not limited to physical or mechanical connections, but may include electrical connections, whether direct or indirect. The term "plurality" as used herein means two or more. "and/or" describes an association relationship of an association object, meaning that there may be three relationships, e.g., "a and/or B" may mean: a exists alone, A and B exist together, and B exists alone. The character "/" generally indicates that the context-dependent object is an "or" relationship. The terms "first," "second," "third," and the like, as used herein, are merely distinguishing between similar objects and not representing a particular ordering of objects.

Example 1

An embodiment of the present application provides a supervision system for drug production, fig. 1 is a block diagram of a structure of a supervision system for drug production according to an embodiment of the present application, and as shown in fig. 1, the system includes an enterprise end module 11, a supervision end module 12 and a black box module 13;

an enterprise-side module 11, configured to collect drug production data of a drug production enterprise, where the drug production data includes drug product data, drug intermediate data, drug process yield data, and drug raw and auxiliary material data;

It should be noted that, the enterprise module 11 is a client (for example) used by a specific pharmaceutical manufacturing enterprise, and the main user of the client is a system development maintainer, a system administrator and a pharmaceutical enterprise manufacturer; the client can be a hardware client or a software client, and if the client is a software client, the client can run on a conventional browser (such as IE10/IE11/Chrome/360 safe browser/red lotus); the client has security requirements, including specifically software security requirements, environmental security requirements, and data security requirements.

1. Software security requirements

(1) User security: the system user needs to meet the requirements of provincial office unified users and unified authorities, and meanwhile, effective security measures are adopted to identify the user identity of the login user, and compare and authenticate the user name and the password to ensure that the login user is a legal user. (2) rights control: and strict system access authority control measures are adopted to ensure the safety of enterprise operation data, and an application system access authority control module is developed to ensure the safety of the enterprise data on one hand and perform authority management on the other hand. (3) other requirements: after software development is completed, an aggressiveness test and a pressure test are required to be carried out, so that the system is ensured to have certain anti-aggression capability and access pressure, and meanwhile, a system emergency plan is suggested to be formulated in a grading manner.

2. Environmental safety requirements

(1) Operating system security: the method requires the use of a normal and stable server version operating system (such as Windows/Linux/CentOs/kylin. Operating system code: UTF-8.SDK:Java Development Kit1.8 +), upgrading system patches every week, strengthening hierarchical management measures on passwords, and achieving the safety of operating system software. (2) database software security: the database used should adopt the data partition management method (such as Mysql/SQLServer), the data is stored in partitions; the password and authority requirements of the database system are strictly managed, the performance of the database is regulated, and database backup software is preferably used for periodically carrying out cold and hot backup on data in the database. (3) application server software security: the use of mainstream application server software (e.g., nginx/Tomcat) requires high security and stability of the server software. (4) safety of antivirus software: the method requires to install legal high-performance antivirus software, make security measures, upgrade virus libraries every day, and prevent virus infection.

3. Data security requirements

(1) Backing up data: and (3) making a detailed database backup system and scheme, carrying out cold backup once a week and incremental backup once a day, and ensuring the safety of database data. (2) application data backup: and establishing a regular backup system for program data and user non-database data deployed on an application server, backing up the data once a week, and guaranteeing data security. (3) network and hardware security requirements: setting a communication network to set an audit link, performing security audit on network access users, preventing illegal equipment and users from accessing, and finding suspicious behaviors and giving an alarm and prompting in time.

The monitoring end module 12 is configured to acquire drug production data of each drug production enterprise acquired by the enterprise end module;

It should be noted that, the supervision module 12 is a client used by a specific supervision organization, and the main user of the client is a system development maintainer, a system administrator and a medicine supervision business person; the client can be a hardware client or a software client, and if the client is a software client, the client can run on a conventional browser (such as IE10/IE11/Chrome/360 safe browser/red lotus); the client also has the same security requirements as the enterprise-side module 11 described above, including in particular software security requirements, environmental security requirements, and data security requirements.

The black box module 13 is used for providing algorithm analysis service and risk early warning service for the enterprise terminal module according to the drug production data; and according to the drug production data, responsibility tracing service and risk early warning service are provided for the supervision terminal module.

It should be noted that, the black box module 13 also has the same security requirements as the enterprise-side module 11 and the supervision-side module 12.

For the black box module 13:

Fig. 2 is a schematic technical architecture of a black box module according to an embodiment of the present application, and as shown in fig. 2, in a service logic processing layer of the black box module, a security filter is used to execute various service provided by the black box module, including an algorithm model service (i.e., an algorithm analysis service).

Specifically, the black box module 13 is configured to provide a product quality consistency analysis service, a dispersion analysis service, and a product trend analysis service for the enterprise terminal module according to the pharmaceutical product data.

Preferably ① product quality consistency analysis service.

The black box module 13 is configured to calculate a product quality consistency analysis result according to a product quality consistency analysis formula according to the pharmaceutical product data, where the pharmaceutical product data is single detection item data (such as microbiological limit detection item data) of all batches of pharmaceutical products, and the product quality consistency analysis formula:

In the method, in the process of the invention, K is the detection value of the latest batch of medical finished products, x _i is the detection value of the ith batch of medical finished products,/>The average value of the detection values of the pharmaceutical product items of all batches is n, and the number of the batches is n.

The product quality consistency analysis result is the analysis result of a single detection item. If the product quality consistency analysis result is closer to 0, the quality consistency of the medicine finished product of the same detection item is strong. Therefore, when the analysis result of the product quality consistency deviates from 0 and is larger than a preset early warning value (for example, 3 times of standard deviation larger than the data of the medical finished products), the product quality consistency is deviated from a reasonable fluctuation range, and risk early warning is performed.

Preferably ② dispersion analysis services.

The black box module 13 is configured to calculate a dispersion analysis result according to a dispersion analysis formula according to the pharmaceutical product data, where the pharmaceutical product data is all detection item data (such as microbial limit detection item data) of a single batch of pharmaceutical products, and the dispersion analysis formula:

Wherein x _i is the medical product item detection value of the ith detection item, The average value of the detection values of the pharmaceutical product items corresponding to the detection items is n, and the number of the detection items is n.

The dispersion analysis result is a single batch of analysis result. If the dispersion analysis result is closer to 1, the quality consistency of the same batch of medical finished products is strong. Therefore, when the dispersion analysis result deviates from 1 and is larger than the preset early warning value, the deviation from the reasonable fluctuation range is indicated, and risk early warning is carried out.

Preferably ③ end product trend analysis service.

The black box module 13 is configured to form a trend chart by combining preset upper and lower limit range values after cleaning the medical product data according to the medical product data, wherein the medical product data must not exceed the upper and lower limit ranges.

Based on the key quality index of the finished medicine product, a line graph is made to intuitively reflect the fluctuation condition of data among different batches. And if the data of the key quality index exceeds the standard limit, performing risk early warning.

Specifically, the black box module 13 is configured to provide a production link stability analysis service and an intermediate trend analysis service for the enterprise terminal module according to the pharmaceutical intermediate data.

Preferably ① production link stability analysis service.

The black box module 13 is configured to calculate a production link stability analysis result according to a production link stability analysis formula according to pharmaceutical intermediate data, where the pharmaceutical intermediate data is single detection item data (such as pH detection item data, ignition residue detection item data, and loading difference detection item data) of all batches of pharmaceutical intermediates, and the production link stability analysis formula:

Wherein X _i is the detection value of the pharmaceutical intermediate item of the ith batch, The average value of the detection values of all batches of pharmaceutical intermediate items is n, which is the number of batches.

The stability analysis result of the production link is the analysis result of a single detection item. And if the stability analysis result of the production link is within the set upper and lower limit ranges, the production link is in a stable state. Therefore, when the stability analysis result of the production link deviates from the set upper and lower limit ranges, risk early warning is performed.

Preferably ② intermediate trend analysis service

The black box module 13 is configured to form a trend chart by combining preset upper and lower limit range values after cleaning the medical intermediate data according to the medical intermediate data, wherein the medical intermediate data must not exceed the upper and lower limit ranges.

Based on key quality indexes of the pharmaceutical intermediate, a line graph is taken, and the fluctuation condition of data among different batches is intuitively reflected. And if the data of the key quality index exceeds the standard limit, performing risk early warning.

Specifically, the black box module 13 is configured to provide the enterprise-side module with a production node yield deviation risk analysis service according to the pharmaceutical process yield data.

Preferably, the black box module 13 is configured to calculate the pharmaceutical process yield data according to the formula: yield = pharmaceutical process yield data/theoretical pharmaceutical process yield data, the yield is calculated, if the yield is within the upper and lower limit range of the preset process production parameters, the yield of the production node is normal, and if the yield exceeds the upper and lower limit range of the preset process production parameters, risk early warning is carried out. The upper and lower limit ranges of the process production parameters are set as the internal process settings of the medicine production enterprises.

Specifically, the black box module 13 is configured to provide raw and auxiliary material inspection and analysis services for the enterprise terminal module according to the medical raw and auxiliary material data.

Preferably, the black box module 13 is configured to calculate a raw and auxiliary material inspection and analysis result according to a raw and auxiliary material inspection and analysis formula according to the raw and auxiliary material data, where the raw and auxiliary material inspection and analysis formula is a single detection item data of all batches of medical intermediates:

wherein X _i is the detection value of the pharmaceutical raw and auxiliary material item of the ith batch, The average value of the detection values of the medicine raw and auxiliary material items of all batches is obtained, and n is the number of the batches.

And checking and analyzing the raw materials and the auxiliary materials to obtain an analysis result of a single detection item. If the checking and analyzing result of the raw materials and the auxiliary materials is larger than the preset early warning value, the deviation from the reasonable fluctuation range is indicated, and risk early warning is carried out.

In addition, the black box module 13 is further configured to provide a similarity analysis service for the enterprise-side module.

Preferably, the black box module 13 is further configured to match a pharmaceutical intermediate (which may be matched by name) that has a correspondence with a pharmaceutical product; based on a plurality of preset indexes, the medical product data and the medical intermediate data are subjected to superposition drawing so as to analyze the difference condition between the medical product and the medical intermediate, and if the content trend of the same preset index of the medical intermediate and the medical product has obvious difference, risk early warning is carried out to investigate and analyze the production process from the medical intermediate to the medical product.

The black box module 13 is further configured to provide basic information of a corresponding pharmaceutical manufacturing enterprise for the enterprise side module, where the basic information includes interface query information, log query information, data synchronization information, and detection report information.

The black box module 13 is further configured to provide the supervision module with enterprise information of each pharmaceutical manufacturing enterprise, where the enterprise information includes product information, credit evaluation information, and industry distribution information.

The black box module 13 is further configured to provide data storage services for the enterprise-side module and the supervision-side module, store the drug production data collected by the enterprise-side module, and store the drug production data obtained by the supervision-side module.

The enterprise end module 11, the supervision end module 12 and the black box module 13 in the embodiment of the application solve the problem of accurately controlling the medicines produced and processed by the medicine mechanized production enterprises, realize risk early warning based on the black box and related data in the medicine production process, and can accurately control the quality and safety of the medicines produced and processed by the medicine mechanized production enterprises.

Example 2

An embodiment of the application provides a supervision system for drug production, fig. 3 is a hardware schematic diagram of a black box module according to an embodiment of the application, and as shown in fig. 3, the black box module provided by the embodiment of the application is a matched integrated hardware device of a drug safety production management platform. The equipment is provided with a touch display screen, a multifunctional control panel, a power module, a UPS, a main board and various function output interfaces (an internal and external network connection network port, HDMI and USB interfaces).

Fig. 4 is a schematic diagram of a hardware interface of the black box module according to an embodiment of the present application, as shown in fig. 4, LAN4: black box internal local area network, IP network segment 192.168.124; LAN1/LAN2/LAN3: the system can be connected with the Internet, private networks and local area networks; GPS: a GPS antenna interface; LORA: the sensing equipment collects an antenna; USB: two USB2.0 and one USB3.0.

The black box module has the functions of collecting temperature and humidity of a node, positioning, vibration alarming, low-voltage alarming, unlocking alarming (sound alarming, short message alarming) and the like, and the table 2 is a product hardware example table of the black box module according to the embodiment of the application, as shown in the table 2,

TABLE 2

Based on the hardware schematic diagram, the hardware interface schematic diagram, and the product hardware example table of the black box module, it can be known that the black box module in the embodiment of the application has the following functions:

① The main control is provided with a GPS positioning sensor and a 4G module base station for positioning, and the longitude and latitude can be displayed on a display screen; when the equipment abnormality log is stored, the longitude and latitude at the time are stored. The GPS positioning is preferred over the base station positioning, when the GPS can acquire data, the GPS positioning is used, and when the GPS does not acquire data, the base station is used for acquiring longitude and latitude information positioning. The method comprises the following steps: 1. and a GPS antenna is inserted, the tail end of the antenna is connected to the outside, longitude and latitude information can be obtained within 5 minutes, and the longitude and latitude information is displayed in the display screen information of the black box module. 2. When the tail end of the GPS antenna cannot be connected to the outside, a base station positioning function is adopted, the base station positioning function needs to ensure that a 4G card is inserted (the GPS antenna is pulled out), longitude and latitude information can be obtained within 5 minutes after the card is inserted, and the state in the display screen information of the black box module is changed from 'no positioning' to longitude and latitude data.

② The temperature and humidity of the current place can be acquired through the node temperature and humidity sensor, and the temperature and humidity can be transmitted to the main control display through wireless transmission. The transmission distance of the temperature and humidity sensor is different due to different environments, and the transmission distance is as close to a medicine safety intelligent supervision black box host as possible during installation.

③ The equipment shakes, moves beyond the abnormal conditions such as the set distance (the settable distance), violent unlocking or low voltage, and the like, and the buzzer sounds and simultaneously sends an alarm short message (the alarm mobile phone number can be set). It should be noted that any one of the anomalies that the input voltage is lower than 210 v, the power is off, the vibration, the moving distance is greater than the set value, the violent unlocking and the like can give out an audible alarm. . The alarm mobile phone number is supported to be set, and a black box supports 5 mobile phone numbers at most.

④ Various abnormal alarm logs can be recorded, and the logs comprise a mobile log, a starting log, a low-voltage log, a vibration log and an abnormal unlocking log.

⑤ The unlocking password can be input through a software interface of the display screen, and the case of the black box module can be automatically opened (unauthorized personnel cannot unlock without the password).

⑥ The abnormal conditions such as vibration, movement exceeding a set distance, violent unlocking or low voltage are recorded and stored, time, longitude and latitude and events are included, and related logs can be checked on a liquid crystal screen.

⑦ The temperature sensor is arranged in the equipment, and the temperature in the equipment is detected in real time and displayed.

⑧ TFT LCD clock, working hour meter, log, company name LOGO and pilot lamp, etc. can realize touch selection menu page and slip selection menu page. The device is powered on to start timing, data is stored in real time, the data is stored in time when the device is powered off, the black box leaves the factory until the total running time is 0.1 hour, and the data is refreshed every 0.1 hour.

⑨ The system can be in interface connection with a server to transmit related data, and can also view the connection state of the server.

⑩ And the data transmission between the main control and the sensor nodes adopts a LORA wireless technology to realize wireless point distribution.

The above-described respective modules may be functional modules or program modules, and may be implemented by software or hardware. For modules implemented in hardware, the various modules described above may be located in the same processor; or the above modules may be located in different processors in any combination.

An embodiment of the present application provides a method for monitoring and controlling production of medicines, and fig. 5 is a flowchart of steps of a method for monitoring and controlling production of medicines according to an embodiment of the present application, and as shown in fig. 5, the method is performed based on the system in the above embodiment, and the method includes the following steps:

Step S502, obtaining medicine production data of a medicine production enterprise, wherein the medicine production data comprise medicine finished product data, medicine intermediate data, medicine process yield data and medicine raw and auxiliary material data;

step S504, obtaining a medical analysis result through a preset analysis algorithm according to the drug production data, wherein the medical analysis result is used for judging whether production risks exist in a drug production enterprise.

In some embodiments, deriving the medical analysis result from the drug production data by a preset analysis algorithm comprises:

According to the medical product data, a first medical analysis result is obtained through a product quality consistency analysis algorithm, a dispersion analysis algorithm and a product trend analysis algorithm respectively;

According to the medical intermediate data, a second medical analysis result is obtained through a production link stability analysis algorithm and an intermediate trend analysis algorithm respectively;

obtaining a third medical analysis result through a production node yield deviation risk analysis algorithm according to the medical process yield data;

According to the raw and auxiliary material data of the medicines, a fourth medicine analysis result is obtained through a raw and auxiliary material inspection analysis algorithm;

and obtaining a fifth medical analysis result through a similarity analysis algorithm according to the medical finished product data and the medical intermediate data.

Through the step S502 and the step S504 in the embodiment of the application, the problem of how to accurately control the medicines produced and processed by the medicine mechanized production enterprises is solved, the risk early warning based on the black box and related data in the medicine production process is realized, and the quality and the safety of the medicines produced and processed by the medicine mechanized production enterprises can be accurately controlled.

It should be noted that the steps illustrated in the above-described flow or flow diagrams of the figures may be performed in a computer system, such as a set of computer-executable instructions, and that, although a logical order is illustrated in the flow diagrams, in some cases, the steps illustrated or described may be performed in an order other than that illustrated herein.

The present embodiment also provides an electronic device comprising a memory having stored therein a computer program and a processor arranged to run the computer program to perform the steps of any of the method embodiments described above.

Optionally, the electronic apparatus may further include a transmission device and an input/output device, where the transmission device is connected to the processor, and the input/output device is connected to the processor.

It should be noted that, specific examples in this embodiment may refer to examples described in the foregoing embodiments and alternative implementations, and this embodiment is not repeated herein.

In addition, in combination with the drug production monitoring method in the above embodiment, the embodiment of the application can be implemented by providing a storage medium. The storage medium has a computer program stored thereon; the computer program, when executed by a processor, implements any of the drug production monitoring methods of the above embodiments.

In one embodiment, a computer device is provided, which may be a terminal. The computer device includes a processor, a memory, a network interface, a display screen, and an input device connected by a system bus. Wherein the processor of the computer device is configured to provide computing and control capabilities. The memory of the computer device includes a non-volatile storage medium and an internal memory. The non-volatile storage medium stores an operating system and a computer program. The internal memory provides an environment for the operation of the operating system and computer programs in the non-volatile storage media. The network interface of the computer device is used for communicating with an external terminal through a network connection. The computer program when executed by a processor implements a pharmaceutical production supervision method. The display screen of the computer equipment can be a liquid crystal display screen or an electronic ink display screen, and the input device of the computer equipment can be a touch layer covered on the display screen, can also be keys, a track ball or a touch pad arranged on the shell of the computer equipment, and can also be an external keyboard, a touch pad or a mouse and the like.

In one embodiment, fig. 6 is a schematic diagram of an internal structure of an electronic device according to an embodiment of the present application, and as shown in fig. 6, an electronic device, which may be a server, is provided, and an internal structure diagram thereof may be as shown in fig. 6. The electronic device includes a processor, a network interface, an internal memory, and a non-volatile memory connected by an internal bus, where the non-volatile memory stores an operating system, computer programs, and a database. The processor is used for providing computing and control capabilities, the network interface is used for communicating with an external terminal through a network connection, the internal memory is used for providing an environment for the operation of an operating system and a computer program, the computer program is executed by the processor to realize a medicine production supervision method, and the database is used for storing data.

It will be appreciated by those skilled in the art that the structure shown in fig. 6 is merely a block diagram of a portion of the structure associated with the present inventive arrangements and is not limiting of the electronic device to which the present inventive arrangements are applied, and that a particular electronic device may include more or fewer components than shown, or may combine certain components, or have a different arrangement of components.

Those skilled in the art will appreciate that implementing all or part of the above described methods may be accomplished by way of a computer program stored on a non-transitory computer readable storage medium, which when executed, may comprise the steps of the embodiments of the methods described above. Any reference to memory, storage, database, or other medium used in embodiments provided herein may include non-volatile and/or volatile memory. The nonvolatile memory can include Read Only Memory (ROM), programmable ROM (PROM), electrically Programmable ROM (EPROM), electrically Erasable Programmable ROM (EEPROM), or flash memory. Volatile memory can include Random Access Memory (RAM) or external cache memory. By way of illustration and not limitation, RAM is available in a variety of forms such as Static RAM (SRAM), dynamic RAM (DRAM), synchronous DRAM (SDRAM), double Data Rate SDRAM (DDRSDRAM), enhanced SDRAM (ESDRAM), synchronous link (SYNCHLINK) DRAM (SLDRAM), memory bus (Rambus) direct RAM (RDRAM), direct memory bus dynamic RAM (DRDRAM), and memory bus dynamic RAM (RDRAM), among others.

It should be understood by those skilled in the art that the technical features of the above-described embodiments may be combined in any manner, and for brevity, all of the possible combinations of the technical features of the above-described embodiments are not described, however, they should be considered as being within the scope of the description provided herein, as long as there is no contradiction between the combinations of the technical features.

The above examples illustrate only a few embodiments of the application, which are described in detail and are not to be construed as limiting the scope of the application. It should be noted that it will be apparent to those skilled in the art that several variations and modifications can be made without departing from the spirit of the application, which are all within the scope of the application. Accordingly, the scope of protection of the present application is to be determined by the appended claims.

Claims (10)

1. A supervision system for drug production, which is characterized by comprising an enterprise end module, a supervision end module and a black box module;

The enterprise terminal module is used for collecting medicine production data of a medicine production enterprise, wherein the medicine production data comprise medicine finished product data, medicine intermediate data, medicine process yield data and medicine raw and auxiliary material data;

The supervision terminal module is used for acquiring the medicine production data of each medicine production enterprise acquired by the enterprise terminal module;

the black box module is used for providing algorithm analysis service and risk early warning service for the enterprise terminal module according to the drug production data; and providing responsibility tracing service and risk early warning service for the supervision terminal module according to the medicine production data.

2. The system of claim 1, wherein the black box module is configured to provide a product quality consistency analysis service, a dispersion analysis service, a similarity analysis service, and a product trend analysis service to the enterprise-side module based on the pharmaceutical product data.

3. The system of claim 2, wherein the black box module is configured to provide a production link stability analysis service, a similarity analysis service, and an intermediate trend analysis service to the enterprise-side module according to the pharmaceutical intermediate data.

4. The system of claim 3, wherein the black box module is configured to provide production node yield bias risk analysis services to the enterprise-side module based on the pharmaceutical process yield data.

5. The system of claim 4, wherein the black box module is configured to provide similarity analysis service for the enterprise-side module according to the pharmaceutical raw material data.

6. The system of claim 1, wherein the black box module is configured to provide the enterprise-side module with basic information corresponding to a pharmaceutical manufacturing enterprise, wherein the basic information includes interface query information, log query information, data synchronization information, and inspection report information.

7. The system of claim 1, wherein the black box module is configured to provide enterprise information for each pharmaceutical manufacturing enterprise to the administration side module, wherein the enterprise information includes product information, credit rating information, and industry distribution information.

8. The system of claim 1, wherein the black box module is configured to provide data storage services for the enterprise-side module and the administration-side module, store pharmaceutical production data collected by the enterprise-side module, and store pharmaceutical production data obtained by the administration-side module.

9. A method of supervising the production of a pharmaceutical product, wherein the method is performed based on the system of any one of claims 1 to 8, the method comprising:

acquiring medicine production data of a medicine production enterprise, wherein the medicine production data comprises medicine finished product data, medicine intermediate data, medicine process yield data and medicine raw and auxiliary material data;

And obtaining a medical analysis result through a preset analysis algorithm according to the medicine production data, wherein the medical analysis result is used for judging whether the medicine production enterprises have production risks or not.

10. The method of claim 9, wherein deriving a medical analysis result from the drug production data by a preset analysis algorithm comprises:

According to the medicine finished product data, a first medicine analysis result is obtained through a product quality consistency analysis algorithm, a dispersion analysis algorithm and a finished product trend analysis algorithm respectively;

according to the medical intermediate data, a second medical analysis result is obtained through a production link stability analysis algorithm and an intermediate trend analysis algorithm respectively;

Obtaining a third medical analysis result through a production node yield deviation risk analysis algorithm according to the medical process yield data;

according to the medicine raw and auxiliary material data, a fourth medicine analysis result is obtained through a raw and auxiliary material inspection analysis algorithm;

And obtaining a fifth medical analysis result through a similarity analysis algorithm according to the medical finished product data and the medical intermediate data.