JP7561152B2 - Distribution quality control system, distribution quality control method and program - Google Patents

Description

The present invention relates to a technology that is effective in managing the distribution quality of pharmaceuticals.

Recently, to ensure that patients, the ultimate beneficiaries, can use medicines with peace of mind, owners of medicines are required to guarantee the integrity of the medicines (meaning that the medicines are manufactured based on the marketing approval, maintained in the state in which they were released to the market, and that the quality is not deteriorated, tampered with, or destroyed), and the GDP (Good Distribution Practices) guidelines have been formulated in Japan as well. The GDP guidelines require the recording and management of documents such as storage methods (e.g., environmental control of temperature, humidity, light, etc.), security (e.g., measures to prevent the inflow of counterfeit medicines, measures to prevent theft), and work history (e.g., work procedures, work records) in order to guarantee the management of the medicine distribution route.
For example, Patent Document 1 provides a technology for acquiring information on environmental conditions for the resale of pharmaceuticals and sharing the information on environmental conditions with distributors and wholesalers.
Furthermore, Patent Document 2 provides a technique for recording various data during transportation in a state that cannot be changed by a specific user, and for complying with GDP.

JP 2017-204200 A JP 2019-28965 A

In the pharmaceutical distribution process, there are various parties involved, such as pharmaceutical manufacturers, pharmaceutical wholesalers, and logistics and delivery companies. In other words, each party involved in distribution manages pharmaceuticals in their respective processes and guarantees the quality of the distribution. Pharmaceutical management is based on a contract concluded between the parties, and the owner of the pharmaceutical (also called the "quality manager") wants to confirm that all parties involved are properly fulfilling this contract and that the pharmaceuticals are being properly managed. Normally, when the owner of the pharmaceutical wants to check the status of contract fulfillment and the status of pharmaceutical management, he or she needs to check with each party involved, which makes the confirmation process cumbersome.
Therefore, there is a need for technology that can simplify the process of verifying GDP data for each stakeholder.
However, in the techniques described in Patent Documents 1 and 2, the so-called quality manager had to individually check the GDP data of each party who had been requested to perform work such as transportation and storage, and this did not lead to simplification of the checking work.
Therefore, the inventors realized that a mechanism is needed to simplify the process of verifying GDP-related data for each related party.

The present invention aims to provide a distribution quality control system, distribution quality control method, and program that extracts regulations regarding transportation and storage from contract data related to pharmaceuticals, manages data related to transportation and storage generated during pharmaceutical distribution operations in chronological order (traceability), and makes it easy to understand from this data whether the pharmaceutical distribution process complies with, for example, GDP.

The present invention provides a distribution quality control system for managing distribution quality in a pharmaceutical supply chain, comprising :
A contract data acquisition unit that acquires contract data for each business agreed upon between legitimate distribution parties in the pharmaceutical supply chain ;
An extraction unit that extracts regulations regarding transportation and storage from the acquired contract data;
a distribution management data acquisition unit that acquires distribution management data related to the transportation and storage of the medicine during each of the operations together with identification information of the medicine;
A collation unit that compares the extracted rule with the acquired distribution management data;
A matching result recording unit that records the matching result together with the identification information of the medicine;
a traceability unit that applies a time series sorting based on the sorting of the order of tasks and the sorting of the dates and times of each task to at least one of the contract data, the distribution management data, and the collation results, and records the results of the application;
The present invention provides a supply chain distribution quality control system that includes:

According to the present invention, a distribution quality control system that manages the distribution quality of a pharmaceutical supply chain acquires contract data for each operation agreed upon between legitimate distribution parties in the pharmaceutical supply chain , extracts regulations regarding transportation and storage from the acquired contract data, acquires distribution management data regarding the transportation and storage of the pharmaceutical during each operation together with identification information of the pharmaceutical, compares the extracted regulations with the acquired distribution management data, records the comparison result together with the identification information of the pharmaceutical, applies a chronological sorting based on a sorting of the order of operations and a subsequent sorting of the dates and times of each operation to at least one of the contract data, the distribution management data and the comparison result, and records the result of the application.

This invention is in the category of a system, but the same effects and advantages can be achieved with methods and programs.

According to the present invention, contract data related to pharmaceuticals and data related to transportation and storage that arise during business operations are managed in chronological order, and from this data it becomes possible to easily understand whether the distribution process is in compliance with, for example, GDP.

FIG. 1 is a diagram for explaining an overview of a distribution quality control system 1. FIG. 1 is a diagram for explaining an overview of the GDP guidelines. FIG. 1 is a diagram showing the functional configuration of a distribution quality control system 1. FIG. 2 is a flowchart showing a contract data management process executed by the distribution quality control system 1. FIG. 2 is a flowchart showing a distribution management data management process executed by the distribution quality control system 1. FIG. 2 is a flowchart showing a collation process executed by the distribution quality control system 1. FIG. 4 is a diagram illustrating an example of an incident occurrence notification 40. FIG. 13 is a flowchart showing a tracking and recording process executed by the distribution quality control system 1. A diagram showing a part of the system configuration when executing a recording method using a distributed management ledger. 3 is a conceptual diagram showing an example of data held in a storage unit 50. FIG. FIG. 13 is a flowchart showing a provision process executed by the distribution quality control system 1.

Below, a detailed description of the mode for carrying out the present invention (hereinafter, the embodiment) will be given with reference to the attached drawings. In the following drawings, the same elements are given the same numbers or symbols throughout the description of the embodiment.

[Basic concept/basic configuration]
1 is a diagram for explaining an overview of the distribution quality control system 1. The distribution quality control system 1 is a system including at least a computer 10 for managing the distribution quality of pharmaceuticals.
In this embodiment, the distribution quality control system 1 is implemented by a computer 10 implemented by the cloud or the like, and includes a pharmaceutical factory, an import company, a pharmaceutical factory, a delivery company, a manufacturing company warehouse, and a pharmaceutical company that are responsible for the production, storage, and transportation of pharmaceutical products. A person in charge computer 20 for inputting and outputting data to a person in charge 3 at a wholesaler warehouse (these warehouses may be owned by a specific logistics company), and a user of the system such as an owner of the drug who is the shipper, This system is connected to a user terminal 30 that manages the system so that data communication is possible.

In this embodiment, the premise is that the work involves the manufacturing, storage and/or transportation of pharmaceuticals, and each person in charge 3 (for example, a pharmaceutical factory and a logistics company that operates a manufacturing company warehouse) has entered into a specific contract, and the person in charge 3 in charge of each process performs work based on this contract.

The relationship between the distribution quality control system 1 of the present invention and the GDP guidelines will be described. As shown in Fig. 2, the GDP guidelines aim to ensure the integrity of pharmaceuticals throughout the distribution process from manufacturers to pharmacies, stores/household distributors, and medical institutions in order to ensure proper distribution of pharmaceuticals, and prescribe methods for maintaining the integrity of pharmaceuticals, involving manufacturers/distributors, wholesalers, and logistics and delivery companies that are entrusted with transport, storage, and other operations. Depending on the actual form of distribution, wholesalers, other logistics companies, and transport companies may not be involved.
In principle, the scope of application of the GDP guidelines does not include raw material manufacturers as shown in FIG. 2. However, in the following embodiment, the scope of application will be described as including shipments from pharmaceutical factories as shown in FIG. 1.
The distribution quality control system 1 according to the present invention may or may not include raw material manufacturers. Of course, depending on the form of distribution, wholesalers may not be included, and manufacturers may not be included if wholesalers manage the distribution quality within their own range independently.

The following describes an overview of the processing steps when the distribution quality control system 1 records at least one of the contract data, distribution management data, and matching results in chronological order, based on Figure 1.

The computer 10 acquires contract data on business agreements made between parties involved in the legitimate distribution of pharmaceuticals (step S1).
The contract data is data that describes regulations for maintaining quality in all or part of pharmaceutical operations such as manufacturing, storage, transportation, sale, disposal, and return between personnel 3 who are legitimate pharmaceutical distributors, and is in a specified data format (e.g., PDF (Portable Document Format), document file, image file). Disposal is judged and decided by the responsible parties as determined by the contract, such as the manufacturer or the owner of the pharmaceutical, when there is a defect in the pharmaceutical. Defects in the pharmaceutical include the distribution quality of the pharmaceutical.
The contract data is, for example, a basic contract, a quality agreement, and specific measures of the provisions described in the quality agreement. These specific measures are, for example, storage methods, security, work history, education and training, change management, deviation management, hygiene management, and risk management.
The person in charge computer 20 transmits the contract data concluded between the persons in charge 3 to the computer 10 .
The computer 10 receives this contract data and thereby obtains the contract data for the business.

The computer 10 extracts regulations regarding transportation and storage from the acquired contract data (step S2).
The regulations regarding transportation and storage include, for example, storage methods such as temperature control, security such as measures to prevent the inflow of counterfeit drugs and measures to prevent theft, and work history such as work procedures and work records.
The computer 10 identifies the contents of the contract data by performing character recognition, image analysis, etc. on the acquired contract data. The computer 10 extracts regulations regarding transportation and storage from the identified contract data based on a predetermined character string, etc. The computer 10 extracts regulations regarding transportation and storage from each contract data.
Here, the regulation is, for example, the following document: "Drug X must be stored at temperatures below -200 degrees." Keywords to be extracted in advance may be set in order to extract the regulation.

The computer 10 acquires distribution management data regarding the transportation and storage of pharmaceuticals during the business, together with the identification information of the pharmaceuticals (step S3).
The distribution management data is, for example, data on storage methods such as temperature control, security such as measures to prevent the inflow of counterfeit drugs and measures to prevent theft, and work history such as work procedures and work records, in other words, distribution quality data. The identification information of the medicine is identification information for each individual medicine (including each package), but may also be identification information for each manufacturing lot.
Meanwhile, sensors installed on the staff computer 20, delivery trucks, warehouses, etc. transmit pharmaceutical distribution management data (e.g., temperature data during delivery and storage) of pharmaceuticals during operations (during delivery and storage) to the computer 10 along with the pharmaceuticals' identification information.
The computer 10 receives this distribution management data together with the identification information of the medicine, thereby obtaining distribution management data regarding transportation and storage during business operations together with the identification information of the medicine.
The computer 10 may obtain this distribution management data together with the identification information of the medicine from a sensor, recorder, etc., without going through the person in charge computer 20.

The computer 10 compares the extracted regulations with the acquired distribution management data (step S4).
The computer 10 compares the regulations regarding transportation and storage extracted from the contract data for the same business with the acquired distribution management data, and verifies whether the comparison result satisfies the regulations. For example, the computer 10 compares the extracted regulation "Drug X must be stored at -200 degrees or less" with the acquired distribution management data during the business (temperature during the period determined in the contract data) to confirm whether the drug was delivered and stored at -200 degrees or less.

The computer 10 records the matching result together with the drug's identification information (step S5).

The computer 10 records at least one of the contract data, the distribution management data, and the matching results in chronological order (step S6).

The computer 10 provides at least one of the recorded contract data, distribution management data, and collation results to the user (step S7).
The computer 10 acquires a request for providing the recorded data from the user terminal 30. The computer 10 transmits the recorded data to the user terminal 30 based on the acquired request for providing. The user terminal 30 receives this data and displays it on its own display unit.

With this distribution quality control system 1, data related to GDP is managed in chronological order, making it easy to grasp this data related to GDP.

[Functional configuration]
The functional configuration of the distribution quality control system 1 will be described with reference to FIG.
The distribution quality control system 1 comprises at least a computer 10, which is connected to a staff computer 20 managed by each staff member in charge of each task, and a user terminal 30 managed by users such as staff members and owners of pharmaceuticals, via a network 9 such as a public line network or an intranet, for data communication.
The distribution quality control system 1 may include a person in charge computer 20, a user terminal 30, other terminals, devices, etc. in addition to the computer 10. In this case, the distribution quality control system 1 executes the processes described below using any one or a combination of the included computers, terminals, devices, etc.

The computer 10 is a personal computer or a computer having a server function for managing regulations regarding the transportation and storage of medicines.
The computer 10 may be realized, for example, by one computer, or may be realized by multiple computers, such as a cloud computer. In this specification, the cloud computer may be either one that uses any computer in a scalable manner to perform a specific function, or one that includes multiple functional modules to realize a system and uses the functions in any combination.

The computer 10 includes, as its control unit, a CPU (Central Processing Unit), a GPU (Graphics Processing Unit), a RAM (Random Access Memory), a ROM (Read Only Memory), etc., and, as its communication unit, includes a device for enabling communication with other terminals and devices, a contract data acquisition unit 11 for acquiring contract data, and a distribution management data acquisition unit 12 for acquiring distribution management data, etc.
The computer 10 also includes a recording unit such as a data storage unit using a hard disk, semiconductor memory, recording medium, memory card, etc., a matching result recording unit 13 that records the results of matching regulations with distribution management data, and a tracking recording unit 14 that records data in chronological order.
The computer 10 also includes, as processing units, various devices for executing various processes, an extraction unit 15 for extracting regulations regarding transportation and storage from the contract data, and a comparison unit 16 for comparing the regulations with distribution management data.

In the computer 10, the control unit loads a predetermined program and cooperates with the communication unit to realize a contract data acquisition module, a distribution management data acquisition module, a notification module, a provision request acquisition module, and a provision module.
In addition, in the computer 10, the control unit reads a specified program and cooperates with the recording unit to realize a contract data recording module, a distribution management data recording module, a matching result recording module, and a tracking recording module.
In addition, in the computer 10, the control unit reads a predetermined program and cooperates with the processing unit to realize an extraction module, a generation module, a matching module, a judgment module, a sorting module, and a specification module.

The person in charge computer 20 is a computer or personal computer with server functions managed by each person in charge. Like the computer 10 described above, the person in charge computer 20 has a CPU, GPU, RAM, ROM, etc. as a control unit, a device that enables communication with other terminals and devices, etc. as a communication unit, and various devices that execute various processes, etc. as a processing unit.

The user terminal 30 is a terminal device such as a mobile terminal such as a mobile phone, smartphone, or tablet terminal, or a personal computer managed by the user, and is equipped with a CPU, GPU, RAM, ROM, etc. as a terminal control unit, devices that enable communication with other terminals or devices, etc. as a communication unit, and various devices that perform data input and output, etc. as an input/output unit.

Hereinafter, each process executed by the distribution quality control system 1 will be described together with the process executed by each of the modules described above.
In this embodiment, the premise is that the business is related to the manufacturing, storage and/or transportation of pharmaceuticals, and each person in charge has entered into a specific contract with another person, and each person in charge performs work based on this contract.

[Contract Data Management Process Executed by Computer 10]
The contract data management process executed by the computer 10 will be described with reference to Fig. 4. This figure shows a flowchart of the contract data management process executed by the computer 10. This contract data management process is a detailed description of the above-mentioned contract data acquisition process (step S1) and the process of extracting regulations regarding transportation and storage (step S2). This contract data management process is appropriately performed when a contract is concluded between the responsible parties, before the start of work, during work, etc., and is performed at least before or simultaneously with the distribution management data management process described below.

The contract data acquisition module acquires contract data on business agreements made between parties involved in the legitimate distribution of pharmaceuticals (step S10).
The contract data is data on a contract that describes regulations regarding transportation and storage for maintaining distribution quality in part or all of the operations of manufacturing, storage, transportation, sales, disposal, and return of pharmaceuticals between personnel who are legitimate distributors of pharmaceuticals, and is in a specified data format (e.g., PDF, document file, image file). Note that the data format of the contract data is not limited to the above-mentioned examples. Regarding disposal, when there is a problem with the pharmaceutical or its distribution quality, the decision to discard is judged and made by the responsible person determined by the contract, such as the manufacturer or the owner of the pharmaceutical.
The contract data is, for example, concrete measures of the provisions described in the basic contract, quality agreement, and quality agreement. The concrete measures are, for example, storage method, security, work history, education and training, change management, deviation management, hygiene management, and risk management. The storage method is, for example, environmental management measures such as temperature, humidity, and light. The security is, for example, measures to prevent the inflow of counterfeit medicines and measures to prevent theft. The measures to prevent the inflow of counterfeit medicines are, for example, the introduction of counterfeit prevention technology to products and packaging, and theft prevention measures are, for example, entry restrictions, restrictions on opening and closing the doors of transportation vehicles for purposes other than those intended, restrictions on opening pharmaceutical containers, entry restrictions to storage locations, and measures to prevent cargo from collapsing during transportation. The work history is, for example, work procedures and work records in distribution processing work. The change management is, for example, management of bases, delivery companies, and facilities. The deviation management is, for example, temperature management. The hygiene management is, for example, insect control and cleaning management. The risk management is identification of risks due to changes and measures against them. The contract data may be data related to regulations for maintaining the distribution quality of pharmaceuticals when manufacturing, storing, and transporting pharmaceuticals, and may be only a part of these, or may be other data.
The person in charge computer 20 transmits contract data concluded between the persons in charge to the computer 10. Specifically, the person in charge computer 20 transmits to the computer 10 each of the contract data concluded between the raw material manufacturer and the pharmaceutical manufacturing company, the contract data concluded between the raw material manufacturer and the delivery company, the contract data concluded between the pharmaceutical manufacturing company and the distribution center, the contract data concluded between the pharmaceutical manufacturing company and the delivery company, the contract data concluded between the distribution center and the pharmaceutical wholesaler, the contract data concluded between the distribution center and the delivery company, and the contract data concluded between the pharmaceutical wholesaler and the delivery company.
The contract data acquisition module receives these contract data to acquire the contract data of the business.
The type and number of persons in charge are not limited to the above example. In addition, the contract data is not limited to data of a contract concluded by two parties, and may be data of a contract concluded by three or more parties.

The extraction module extracts regulations regarding transportation and storage from the acquired contract data (step S11).
The regulations regarding transportation and storage include, for example, storage methods such as temperature control, security such as measures to prevent the inflow of counterfeit drugs and measures to prevent theft, and work history such as work procedures and work records.
The extraction module identifies the contents of the contract data by performing character recognition, image analysis, etc. on the acquired contract data. The extraction module extracts regulations regarding transportation and storage from the identified contract data based on a predetermined character string, etc. The extraction module extracts regulations regarding transportation and storage from each contract data.
The regulations regarding transportation and storage extracted by the extraction module may include at least one of the storage method, the measures to prevent counterfeit drugs from entering, and the measures to prevent theft. The regulations regarding transportation and storage extracted by the extraction module are not limited to the above examples.

The contract data recording module records the acquired contract data and the extracted regulations (step S12).
The contract data recording module records each contract data, the regulations regarding transportation and storage extracted from each contract data, and the identifier of the person in charge of each contract data in association with each other.
The contract data recording module may be configured to record only the acquired contract data, or may be configured to record only the extracted regulations.

The above is the contract data management process.
The computer 10 executes the processes described below using the contract data and regulations recorded by the above-mentioned contract data management process.

[Distribution Management Data Management Process Executed by Computer 10]
The distribution management data management process executed by the computer 10 will be described with reference to Fig. 5. This figure shows a flowchart of the distribution management data management process executed by the computer 10. This distribution management data management process is a detailed description of the above-mentioned distribution management data acquisition process (step S3). This distribution management data management process is a process that is performed at any time during business operations.

The distribution management data acquisition module acquires data (distribution management data) related to the transportation and storage of medicines during operations, together with identification information of the medicines (step S20).
The distribution management data is, for example, data relating to each of the storage method, security, and work history, and in this embodiment, the data relating to the storage method is temperature data, the data relating to security is data relating to prevention of counterfeiting of products and packages, opening of pharmaceutical containers, opening and closing of doors of transport vehicles at places other than the destination, records of trespassers into storage locations, etc., and the data relating to work history is document data such as work procedures, work records, etc. Note that the distribution management data is not limited to the above examples, and may be data necessary for managing the transport and storage of pharmaceuticals, and may be only a part of these, or may be other data.
The identification information of a medicine is identification information for each individual medicine (including each package), but may be identification information for each manufacturing lot.
The person in charge computer 20 transmits pharmaceutical distribution management data, which is data related to transportation and storage generated during work, together with pharmaceutical identification information to the computer 10. Specifically, the data is obtained by various sensors such as temperature, humidity, light reception, and vibration, and the person in charge computer 20 transmits to the computer 10 data on the production and storage of pharmaceutical raw materials produced by raw material manufacturers, data on the transportation of pharmaceutical raw materials produced by raw material manufacturers to pharmaceutical manufacturing companies, data on the production and storage of pharmaceuticals produced by pharmaceutical manufacturing companies, data on the transportation of pharmaceuticals produced by pharmaceutical manufacturing companies to logistics centers, data on the storage of pharmaceuticals stored at the logistics centers, data on the transportation of pharmaceuticals stored at the logistics centers to pharmaceutical wholesalers, data on the storage of pharmaceuticals owned by pharmaceutical wholesalers, and data on the transportation of pharmaceuticals sold by pharmaceutical wholesalers to medical institutions, together with the measured time and duration and pharmaceutical identification information.
The distribution management data acquisition module receives this distribution management data together with the identification information of the medicine, and thereby acquires distribution management data related to the transportation and storage of the medicine during the operation together with the identification information of the medicine.
The distribution management data acquisition module may acquire this distribution management data together with the identification information of the medicine from a sensor, recorder, etc., without going through the person in charge computer 20.

The case of acquiring data relating to the storage method will be described using temperature data as an example.
The person in charge computer 20 constantly transmits temperature data during work to the computer 10. This temperature data is temperature data of the storage location during storage and temperature data of the cargo compartment during transportation.
The distribution management data acquisition module receives this temperature data and thereby acquires the temperature data.
The case of acquiring data related to security will be described below using data related to prevention of counterfeit drugs and prevention of theft as an example.
The person in charge computer 20 constantly transmits to computer 10 data indicating whether or not a pharmaceutical container has been opened during work (if so, the date, time and location), data indicating whether or not the door of the transport vehicle has been opened at a location other than the destination during work (if so, the date, time and location), and data indicating whether or not someone has entered the storage location during work (if there is an intruder, the date, time and location).
The distribution management data acquisition module receives these data and thereby acquires data related to preventing counterfeit drugs from entering the market and theft.
A case where data relating to work history is obtained will be described below using document data of work procedures and work records as an example.
The person in charge computer 20 constantly transmits document data of work procedures and work records performed during business to the computer 10 .
The distribution management data acquisition module receives this document data and acquires document data on work procedures and work records.

The generation module generates a fluctuation log of the acquired distribution management data (step S21).
The fluctuation log is a record of fluctuations in the acquired distribution management data.
The generation module generates each of the fluctuation logs for each distribution management data.
The generation module generates a fluctuation log for the temperature data. The generation module generates a fluctuation log that records fluctuations in the temperature data from time to time. The generation module also generates a thermal map based on the temperature data of the storage location and the luggage compartment as a fluctuation log.
The generation module generates a change log for each of the opening of the pharmaceutical container, the opening and closing of the door of the transport vehicle at a location other than the destination, and the presence or absence of an intruder at the storage location. The generation module generates a change log by recording, as required, each of the opening or closing of the pharmaceutical container, the opening or closing of the door of the transport vehicle at a location other than the destination, and the presence or absence of an intruder at the storage location.
The generation module generates a change log for document data of work procedures and work records. The generation module generates a change log by recording changes in the document data of work procedures and work records at any time.

The distribution management data recording module records the acquired distribution management data and drug identification information (step S22).
The distribution management data recording module records each acquired distribution management data, a fluctuation log generated from each distribution management data, an identifier of the person performing the task, and identification information of the pharmaceutical product in association with each other.
The distribution management data recording module may be configured to record only the distribution management data and the identification information of the medicine, or may be configured to record only the fluctuation log and the identification information of the medicine.

The above is the distribution management data management process.
The computer 10 executes the processes described below using the distribution management data recorded by the above-mentioned distribution management data management process.

[Matching process executed by computer 10]
The collation process executed by the computer 10 will be described with reference to Fig. 6. Fig. 6 is a flowchart showing the collation process executed by the computer 10. This collation process shows the details of the collation process between the above-mentioned regulations and the distribution management data (step S4) and the recording process of the collation result (step S5). This collation process is a process carried out simultaneously with the above-mentioned distribution management data management process.

The comparison module compares the extracted regulations with the acquired distribution management data (step S30).
The verification module verifies the transport and storage regulations extracted by the above-mentioned contract data management process with the distribution management data acquired by the above-mentioned distribution management data management process. At this time, the verification module verifies the transport and storage regulations for the same business with the distribution management data. In other words, the comparison module compares the regulations for the production and storage of pharmaceutical raw materials produced by the raw material manufacturer with the distribution management data at that time, compares the regulations for the transportation of pharmaceutical raw materials produced by the raw material manufacturer to the pharmaceutical manufacturing company with the distribution management data at that time, compares the regulations for the production and storage of pharmaceuticals manufactured by the pharmaceutical manufacturing company with the distribution management data at that time, compares the regulations for the transportation of pharmaceuticals manufactured by the pharmaceutical manufacturing company to the logistics center with the distribution management data at that time, compares the regulations for the storage of pharmaceuticals stored at the logistics center with the distribution management data at that time, compares the regulations for the transportation of pharmaceuticals stored at the logistics center to pharmaceutical wholesalers with the distribution management data at that time, compares the regulations for the storage of pharmaceuticals owned by the pharmaceutical wholesaler with the distribution management data at that time, and compares the regulations for the transportation of pharmaceuticals sold by the pharmaceutical wholesaler to medical institutions with the distribution management data at that time.

The determination module determines whether the collation result satisfies a regulation (step S31).
The judgment module judges whether the distribution management data is in a state defined by regulations. The judgment module judges, for example, whether the storage method, security, or operation history is in a state defined by regulations, that is, whether an abnormality has occurred in the distribution management data.
The judgment module judges whether each of the following conditions deviates from the prescribed conditions: temperature data, opening of pharmaceutical containers, opening and closing of transport vehicle doors at places other than the destination, trespassers at storage locations, and document data of work procedures and work records. The judgment module detects any of these conditions that deviate from the prescribed conditions as an anomaly, and judges that an incident has occurred.
If the acquired temperature data differs from regulations, the judgment module detects an abnormality in the temperature data and determines that an incident related to the temperature data has occurred. If some or all of the acquired data related to the opening of pharmaceutical containers, the opening and closing of the doors of the transport vehicle at a location other than the destination, and entrants to the storage location differs from regulations, the judgment module determines that an incident related to some or all of the data that differs from regulations has occurred. If the acquired document data differs from regulations, the judgment module detects an abnormality in the work procedures or work records and determines that an incident related to the work procedures or work records has occurred. Similarly, for other contents, if the acquired distribution management data differs from regulations, the judgment module detects an abnormality in the distribution management data and determines that an incident has occurred.
The regulations in this process may include not only those extracted from contract data, but also those extracted from laws, GDP guidelines, etc.

When the determination module determines that the collation result does not satisfy the regulation (step S31: NO), the notification module notifies the occurrence of an incident (step S32).
The notification module creates an incident occurrence notification including the date and time, situation, location, and details of the incident (see FIG. 7). The date and time is the date and time when the incident occurred. The situation is the business situation where the incident occurred, such as during production, storage, or transportation. The location is the location of the person in charge of the business where the incident occurred, or the location where the transportation vehicle is operating during transportation. The details are the details of the abnormality that occurred in the storage method, security, work history, etc. related to the incident that occurred.

[Incident occurrence notification]
The incident occurrence notification will be described with reference to Fig. 7. Fig. 7 is a diagram showing an example of the incident occurrence notification. In Fig. 7, an incident related to temperature will be described as an example.
The notification module creates an incident occurrence notification 40 that includes the date, time, situation, location and details of the incident.
The incident occurrence notification 40 is a notification in which a message 41 indicating that an incident has occurred and an incident column 42 indicating the date and time, status, location, and content of the incident are each arranged in a predetermined position. The message 41 is a character string indicating that an incident has occurred, and indicates "Incident Occurred!". The incident column 42 is a character string indicating the date and time, status, location, and content of the incident. The incident column 42 indicates "Date and Time: October 1, 20201, 9:00" as the date and time when the incident occurred, "Status: In Storage" as the status of the incident, "Location: Logistics Center" as the location of the incident, and "Content: An abnormal temperature occurred at the storage location of Drug X" as the specific content of the incident.

Returning to FIG. 6, the process following step S32 in the collation process will be described.
The notification module transmits the created incident occurrence notification to a person in charge computer 20 or a user terminal 30 managed by a person in charge who owns or manages the location where the incident occurred.
The person in charge computer 20 or the user terminal 30 receives this incident occurrence notification and displays it on its own display unit.
The notification module notifies the user of the incident by displaying an incident occurrence notification on the person in charge computer 20 or the user terminal 30 .
The person in charge views this incident occurrence notification and becomes aware that an incident has occurred.
After executing the process of step S32, the computer 10 executes the process of step S33, which will be described later.

Returning to the process of step S31, the process steps when the determination module determines that the collation result satisfies the regulations will be described.
When the determination module determines that the collation result satisfies the regulation (step S31: YES), the collation result recording module records the collation result together with the drug identification information.
The matching result recording module records each matching result in association with the identifier of the person performing the task and the identification information of the drug.
Here, if the regulation is not satisfied, the matching result recording module records each matching result, the occurrence of the incident, the identifier of the person performing the work, and the identification information of the medicine in association with each other. Note that even in this case, the matching result recording module may be configured to record each matching result, the identifier of the person performing the work, and the identification information of the medicine in association with each other.

This is the verification process.
The computer 10 executes the process described below using the collation result recorded by the above-mentioned collation process.

[Track Recording Process Executed by Computer 10]
The tracking and recording process executed by the computer 10 will be described with reference to Fig. 8. This figure shows a flowchart of the tracking and recording process executed by the computer 10. This tracking and recording process is the details of the process (step S6) of recording at least one of the contract data, distribution management data, and matching results in chronological order. This tracking and recording process is performed after the contract data management process, distribution management data management process, and matching process described above.

The sorting module sorts the contract data, the distribution management data, and the matching results in chronological order (step S40).
Sorting in chronological order means sorting by task order, and further sorting by date and time within each task. The task order is the production and storage of pharmaceutical raw materials produced by the raw material manufacturer, transportation of the pharmaceutical raw materials produced by the raw material manufacturer to the pharmaceutical manufacturing company, production and storage of pharmaceuticals produced by the pharmaceutical manufacturing company, transportation of the pharmaceuticals produced by the pharmaceutical manufacturing company to the logistics center, storage of pharmaceuticals stored at the logistics center, transportation of the pharmaceuticals stored at the logistics center to the pharmaceutical wholesaler, storage of pharmaceuticals owned by the pharmaceutical wholesaler, and transportation of pharmaceuticals sold by the pharmaceutical wholesaler to medical institutions. Note that the tasks are not limited to the above-mentioned examples, and other types and numbers may be used. Furthermore, the task order is not limited to the above-mentioned examples, and can be changed as appropriate.
The sorting module sorts the contract data in the above-mentioned order of tasks. The sorting module sorts the distribution management data in the above-mentioned order of tasks, and further sorts the distribution management data for each task in date and time order. The sorting module sorts the collation results in the above-mentioned order of tasks, and further sorts them in date and time order.
The contract data is not limited to the contract data itself, but may be only information related to the extracted regulations, or may be both the contract data and the regulations.

The tracking and recording module records the rearranged contract data, distribution management data, and matching results in chronological order (step S41).
The tracking record module associates the contract data, the identifier of the person in charge, and the identification information of the medicine, and records them in chronological order; associates the distribution management data, the identifier of the person in charge performing the work, and the identification information of the medicine, and records them in chronological order; and associates the matching results, the identifier of the person in charge performing the work, and the identification information of the medicine, and records them in chronological order.
The tracking and recording module does not need to record all of the contract data, distribution management data, and matching results in chronological order, but may record at least one of them in chronological order.

This completes the tracking and recording process.
The computer 10 executes the process described below using the contents recorded by the above-mentioned tracking and recording process.

[Recording method using a distributed management ledger]
In the above-mentioned contract data management process, distribution management data management process, matching process, and tracking and recording process, the computer 10 itself has been described as recording the contract data, distribution management data, and matching results, but a recording method using a distributed management ledger is also possible. This case will be described with reference to Figures 9 and 10.

FIG. 9 is a diagram showing a part of a system configuration when the computer 10 executes a recording method using a distributed management ledger.
In addition to the configuration shown in FIG. 3, the distribution quality control system 1 has a computer 10 connected to a plurality of storage units 50 via a network 9 so as to be capable of data communication.

The data that is distributed and recorded by the multiple storage units 50 that make up the distributed management ledger will be described with reference to FIG. 10. This figure is a conceptual diagram showing an example of data held in the storage unit 50. One example of a distributed management ledger is blockchain technology. In this embodiment, the contract data, distribution management data, and matching results recorded by each of the above-mentioned processes are distributed and recorded in each storage unit 50. Note that instead of distributing and recording all of the contract data, distribution management data, and matching results, it is also possible to configure at least one of them to be distributed and recorded. Furthermore, the contract data is not limited to the contract data itself, and may be only data related to the extracted regulations, or may be both the contract data and the regulations.

In the figure, the nth block represents the last block in the blockchain, and the nth+1 represents a block being generated that is about to be added to the blockchain in which blocks up to the nth block are registered. The nth block contains the hash value of the previous block, a nonce value unique to the block, contract data, distribution management data, and the matching result.

When a new block is to be added to a blockchain in which blocks up to the nth block have been registered, the storage unit 50 performs a calculation to find a nonce value such that the hash value of the block satisfies certain conditions. Based on the calculation result, the storage unit 50 registers a new block in the blockchain that includes the hash value of the previous block, the nonce value, contract data, distribution management data, and the matching result.

The above is the recording method using a distributed management ledger.
In this embodiment, a form using a blockchain has been described as an example of a distributed management ledger, but the distributed management ledger in the present invention is not limited to a blockchain.

[Providing process executed by computer 10]
The provision process executed by the computer 10 will be described with reference to Fig. 11. The figure shows a flowchart of the provision process executed by the computer 10. This provision process is a detailed process (step S7) for providing at least one of the contract data, the distribution management data, and the collation results recorded in chronological order to the user.

The provision request acquisition module acquires a request for providing the recorded data from the user (step S50).
The user terminal 30 accepts input of a request for providing the recorded data from the user. The recorded data may be the contract data, distribution management data, and matching results recorded in chronological order by the above-mentioned tracking and recording process, or may be all or part of the contract data and regulations recorded by the above-mentioned contract data management process, the distribution management data recorded by the above-mentioned distribution management data management process, and the matching results recorded by the above-mentioned matching process.
The user terminal 30 reads a predetermined code (e.g., a one-dimensional code or a two-dimensional code) in which the request is stored, to receive the request for providing the recorded data. Alternatively, the user terminal 30 receives the request for providing the recorded data on a predetermined input screen.
The user terminal 30 transmits the received provision request to the computer 10 .
The provision request acquisition module receives this provision request, and thereby acquires a request for providing the recorded data from the user.

The identification module identifies data in the acquired provision request (step S51).
The specification module specifies data desired by the user in the provision request. The specification module specifies the data desired by the user from among the contract data, distribution management data, and matching results recorded in chronological order by the above-mentioned tracking and recording process, the contract data and regulations recorded by the above-mentioned contract data management process, the distribution management data recorded by the above-mentioned distribution management data management process, and some or all of the matching results recorded by the above-mentioned matching process.

The providing module provides the identified data to the user (step S52).
The providing module transmits the identified data to the user terminal 30 .
The user terminal 30 receives this data and displays it on its own display unit.
The providing module provides the identified data to the user by displaying the identified data on the user terminal 30.
By viewing this data, the user can easily ascertain the data that he or she desires.

This completes the provision process.

Although each of the above processes is described as a separate process, the computer 10 can be configured to execute a combination of some or all of the above processes. Furthermore, the computer 10 can be configured to execute each process at a timing other than that described.

The above-mentioned means and functions are realized by a computer (including a CPU, an information processing device, and various terminals) reading and executing a predetermined program. The program may be provided, for example, from the computer via a network (SaaS: Software as a Service) or as a cloud service. The program may also be provided in a form recorded on a computer-readable recording medium. In this case, the computer reads the program from the recording medium, transfers it to an internal or external recording device, records it, and executes it. The program may also be recorded in advance on a recording device (recording medium) and provided from the recording device to the computer via a communication line.

Although the embodiments of the present invention have been described above, the present invention is not limited to these embodiments. Furthermore, the effects described in the embodiments of the present invention are merely a list of the most favorable effects resulting from the present invention, and the effects of the present invention are not limited to those described in the embodiments of the present invention.

(1) A distribution quality control system for managing the distribution quality of pharmaceuticals, comprising:
A contract data acquisition unit (e.g., a contract data acquisition unit 11, a contract data acquisition module) that acquires contract data of the business agreed upon between the parties involved in the legitimate distribution of the pharmaceutical product;
An extraction unit (e.g., extraction unit 15, extraction module) that extracts regulations regarding transportation and storage from the acquired contract data;
A distribution management data acquisition unit (e.g., a distribution management data acquisition unit 12, a distribution management data acquisition module) that acquires distribution management data related to the transportation and storage of the medicine generated during the business together with the identification information of the medicine;
A collation unit (e.g., collation unit 16, collation module) that compares the extracted rule with the acquired distribution management data;
A matching result recording unit (e.g., matching result recording unit 13, matching result recording module) that records the matching result together with the identification information of the medicine;
a traceability unit (e.g., traceability unit 14, traceability module) that records at least one of the contract data, the distribution management data, and the matching result in chronological order;
A distribution quality control system that includes:

According to the invention of (1), regulations regarding transportation and storage are extracted from contract data regarding pharmaceuticals, and data related to transportation and storage generated during the distribution of pharmaceuticals is managed in chronological order (traceability), making it possible to manage data related to GDP in chronological order and easily grasp whether it complies with GDP.

(2) The business includes manufacturing, storage, transportation, sale, disposal and return of the pharmaceuticals.
A distribution quality control system as described in (1).

The invention in (2) makes it possible to easily check whether the integrity of pharmaceuticals is maintained throughout the entire supply chain as required by the GDP guidelines, thereby supporting quality assurance during distribution.

(3) The provisions include at least one of the following: a savings method, a measure to prevent the inflow of counterfeit drugs, and a measure to prevent theft;
A distribution quality control system as described in (1).

According to the invention of (3), data on GDP in at least one of the following areas is managed in chronological order: savings during business hours, measures to prevent the inflow of counterfeit drugs, and measures to prevent theft, making it possible to easily grasp this data on GDP.

(4) A method for managing the distribution quality of pharmaceuticals, the method comprising the steps of:
A step of acquiring contract data of a business agreed upon between the parties involved in the legitimate distribution of the pharmaceutical product (e.g., step S10);
A step of extracting regulations regarding transportation and storage from the acquired contract data (e.g., step S11);
A step (e.g., step S20) of acquiring distribution management data related to the transportation and storage of the medicine during the business together with identification information of the medicine;
A step of comparing the extracted rule with the acquired distribution management data (e.g., step S30);
A step of recording the collation result together with the identification information of the medicine (e.g., step S33);
A step of recording at least one of the contract data, the distribution management data, and the collation result in chronological order (e.g., step S41);
A distribution quality control method comprising the steps of:

(5) A computer that manages the distribution quality of pharmaceuticals
A step of acquiring contract data of the business agreed upon between the parties involved in the authorized distribution of the pharmaceutical product (e.g., step S10);
A step of extracting regulations regarding transportation and storage from the acquired contract data (e.g., step S11);
A step of acquiring distribution management data related to the transportation and storage of the medicine during the business together with identification information of the medicine (e.g., step S20);
A step of comparing the extracted rule with the acquired distribution management data (e.g., step S30);
A step of recording the collation result together with the identification information of the medicine (e.g., step S33);
A step of recording at least one of the contract data, the distribution management data, and the collation result in chronological order (e.g., step S41);
A computer readable program for executing the program.

REFERENCE SIGNS LIST 1 Distribution quality control system 3 Person in charge 9 Network 10 Computer 20 Person in charge computer 30 User terminal 40 Incident occurrence notification 41 Message 42 Incident column 50 Storage section

Claims (8)

A distribution quality control system for managing distribution quality in a pharmaceutical supply chain , comprising:
A contract data acquisition unit that acquires contract data for each business agreed upon between legitimate distribution parties in the pharmaceutical supply chain ;
An extraction unit that extracts regulations regarding transportation and storage from the acquired contract data;
a distribution management data acquisition unit that acquires distribution management data related to the transportation and storage of the medicine during each of the operations together with identification information of the medicine;
A collation unit that compares the extracted rule with the acquired distribution management data;
A matching result recording unit that records the matching result together with the identification information of the medicine;
a traceability unit that applies a chronological sorting based on the sorting of the order of tasks and the sorting of the dates and times of each task to at least one of the contract data, the distribution management data, and the collation results, and records the results of the application;
A supply chain distribution quality control system equipped with The business includes manufacturing, storage, transportation, sale, disposal and return of the pharmaceutical products.
The distribution quality control system according to claim 1 . The provisions include at least one of a savings method, a measure to prevent counterfeit drugs from entering the country, and a measure to prevent theft;
The distribution quality control system according to claim 1 . At least one of the contract data, the distribution management data, and the matching result is recorded in a distributed manner;
The distribution quality control system according to claim 1 . The extraction unit performs character recognition or image analysis on the contract data to identify the content of the contract data, and extracts the provision from the identified contract data based on a predetermined character string set in advance.
The distribution quality control system according to claim 1 . The supply chain distribution product quality control system includes:
A terminal that accepts input from a user of the distribution product quality control system in the supply chain is connected in a data communicable manner,
acquiring, from the terminal, a request for providing recorded data desired by the user from among at least a part or all of the contract data, the distribution management data, and the matching results recorded by the tracking and recording unit;
transmitting to the terminal the record data desired by the user, the record data being specified based on the acquired provision request;
The distribution quality control system according to claim 1 . A computer-implemented distribution quality management method for managing distribution quality in a pharmaceutical supply chain, comprising :
A step of acquiring contract data for each business agreed upon between legitimate distribution parties in the pharmaceutical supply chain ;
A step of extracting regulations regarding transportation and storage from the acquired contract data;
acquiring distribution management data related to the transportation and storage of the medicine during each of the operations together with identification information of the medicine;
A step of matching the extracted rule with the acquired distribution management data;
recording the matching result together with the identification information of the medicine;
a step of applying a chronological sorting based on the sorting of the order of tasks and the sorting of the dates and times of each task to at least one of the contract data, the distribution management data, and the collation results, and recording the result of the application;
A method for controlling distribution quality in a supply chain . A computer that manages the distribution quality of pharmaceutical supply chains
A step of acquiring contract data for each business agreed upon between legitimate distribution parties in the pharmaceutical supply chain ;
A step of extracting regulations regarding transportation and storage from the acquired contract data;
acquiring distribution management data related to the transportation and storage of the medicine during each of the operations together with identification information of the medicine;
A step of matching the extracted rule with the acquired distribution management data;
recording the matching result together with the identification information of the medicine;
a step of applying a chronological sorting based on the sorting of the order of tasks and the sorting of the dates and times of each task to at least one of the contract data, the distribution management data, and the collation results, and recording the results of the application;
A computer readable supply chain program for executing the supply chain control program.