CN112330343A - Medicine batch archive tracing system based on block chain - Google Patents

Medicine batch archive tracing system based on block chain Download PDF

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CN112330343A
CN112330343A CN202011287830.9A CN202011287830A CN112330343A CN 112330343 A CN112330343 A CN 112330343A CN 202011287830 A CN202011287830 A CN 202011287830A CN 112330343 A CN112330343 A CN 112330343A
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CN112330343B (en
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金震
王兆君
张京日
徐涛
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Beijing SunwayWorld Science and Technology Co Ltd
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Abstract

The invention provides a block chain-based drug batch file tracing system, and belongs to the technical field of production supervision. The system comprises: the template definition module is used for defining and setting the content and the format of the batch file template according to the requirement and generating a batch file template; the batch file generation module is used for generating an electronic batch file in the drug production process according to the record content of the drug production process and the content and format of a batch file template, and issuing the electronic batch file to a block chain; the batch file export module is used for exporting the generated electronic batch files on each node of the block chain; the batch file transfer module is used for transferring the generated electronic batch files on each node of the block chain; and the batch file query module is used for querying the generated electronic batch files on each node of the block chain.

Description

Medicine batch archive tracing system based on block chain
Technical Field
The invention provides a block chain-based drug batch file tracing system, and belongs to the technical field of production supervision.
Background
In recent years, the frequent occurrence of drug safety accidents has attracted great attention in domestic and foreign society, and as a special commodity, the quality safety of drugs is closely related to the health and life of people, so that in order to avoid the frequent occurrence of drug safety accidents, scientifically and effectively monitoring a drug production supply chain is necessary. At present, a special tracing system is lacked in the tracing situation of the production quality information of the medicines, the tracing is completed based on the use of MES (manufacturing execution system) or QMS (quality management system), and the tracing of the production and packaging information of medicine batches can be realized. It has the following problems: the authenticity of information in the tracing system cannot be guaranteed, and the information is tampered; the workload of the information tracing inquiry process is large, and the efficiency is low.
Disclosure of Invention
The invention provides a block chain-based drug batch file tracing system, which is used for solving the problems that the existing drug production tracing system is low in working efficiency and cannot trace the authenticity of information, and adopts the following technical scheme:
the invention provides a block chain-based drug batch file tracing system, which comprises:
the template definition module is used for defining and setting the content and the format of the batch file template according to the requirement and generating a batch file template;
the batch file generation module is used for generating an electronic batch file in the drug production process according to the record content of the drug production process and the content and format of a batch file template, and issuing the electronic batch file to a block chain;
the batch file export module is used for exporting the generated electronic batch files on each node of the block chain;
the batch file transfer module is used for transferring the generated electronic batch files on each node of the block chain;
and the batch file query module is used for querying the generated electronic batch files on each node of the block chain.
Further, the template definition module comprises a production template definition module and a packaging template definition module, and the batch archive template comprises a production template and a packaging template;
the production template definition module is used for defining the content items of the production template and the size and the position of the area where the content items are located;
and the template definition module for packaging is used for defining the content items of the template for packaging and the size and the position of the area where the content items are located.
Further, the production template definition module includes:
the name specification definition module is used for defining the recording areas and positions of the product name, specification and batch number in the production template;
the time definition module is used for defining the start and end dates and specific time points in the drug production process, and the start and end dates and specific time points of each intermediate process in the drug production process in the areas and positions of the production templates;
the environment definition module is used for defining the area and the position of the environment monitoring record of the drug production in the production template;
the signature definition module is used for defining the area and the position of the signature of a person in charge of each production process in the production template; and defining the signature of the operator in the production step, and/or defining the area and the position of the signature of the operator in the production template;
the raw and auxiliary material defining module is used for defining the area and the position of the batch number and the actual weighing quantity of each raw and auxiliary material in the production template; wherein the batch number and the actual weighed quantity of the raw and auxiliary materials comprise the batch number and the quantity of the input recycling or reworking treatment products;
the operation activity definition module is used for defining related production operation or activity, process parameters and control range in the drug production process, and the area and position of the serial number of the used production equipment in the production template; (ii) a
The intermediate result definition module is used for defining the record of an intermediate control result in the drug production process and the area and the position of the signature of an operator in the production template;
the yield and material calculation process result definition module is used for defining the yield obtained by different production processes and the area and the position of the material balance calculation process and result in the production template when necessary;
and the abnormity definition module is used for defining the area and the position of the record of the special problems and/or abnormal events in the production process of the medicine bottles in the production template.
Further, the production template definition process of the production template definition module includes:
defining the recording area and position of the product name, specification and batch number in the production template;
defining the start and end dates and specific time points in the drug production process, and the start and end dates and specific time points of each intermediate process in the drug production process in the area and the position of each intermediate process in the production template;
defining the area and the position of the environment monitoring record of the drug production in the production template;
defining the area and the position of a responsible person signature of each production process in the production template; and defining the signature of the operator in the production step, and/or defining the area and the position of the signature of the operator in the production template;
defining the area and the position of the batch number and the actual weighed quantity of each raw and auxiliary material in the production template; wherein the batch number and the actual weighed quantity of the raw and auxiliary materials comprise the batch number and the quantity of the input recycling or reworking treatment products;
defining related production operation or activity, process parameters and control range in the production process of the medicine, and the area and the position of the serial number of the used production equipment in the production template; (ii) a
Defining the area and the position of the record of the intermediate control result and the signature of an operator in the production template in the drug production process;
defining the yield obtained by different production processes and the area and the position of the material balance calculation process and the result in the production template when necessary;
defining the areas and locations in the production template of records of special problems and/or abnormal events that occur during the production of the vials.
Further, the template definition module for packaging includes:
the product definition module is used for defining the area and the position of the product name, the specification, the packaging form, the batch number, the production date and the validity period in the template for packaging;
the operation time definition module is used for defining the area and the position of the packaging operation date and the specific time point in the template for packaging;
the first signature definition module is used for defining the area and the position of the signature of a person in charge of the packaging operation in the template for packaging;
a second signature definition module for defining the region and the position of the signature of the operator in the packaging procedure in the template;
the packaging material definition module is used for defining the area and the position of the name, the batch number and the actually used quantity of each packaging material in the template for packaging;
the process definition module is used for defining the area and the position of an inspection record carried out according to a process rule in the template for packaging, wherein the inspection record of the process rule comprises an intermediate control result of the process rule;
an operation definition module, which is used for defining the area and the position of the detailed condition of the packaging operation in the template for packaging, wherein the detailed condition comprises the number of the used equipment and the packaging production line;
the printing definition module is used for defining the area and the position of the real sample of the used printing packaging material recorded in the template for packaging, wherein the real sample of the printing packaging material comprises a batch number and a valid period which are printed and other printing contents; the printed packaging material which is not easy to be filed along with batch packaging records can adopt a copy printed with the content;
the abnormal condition definition module is used for defining the area and the position of a record of a special problem and/or an abnormal event which occur in the medicine packaging process in the template for packaging;
and the other content definition module is used for defining the names and codes of all printed packaging materials and products to be packaged, and the areas and positions of the issuing, using, destroying or returning libraries, the actual yield and the material balance check in the template for packaging.
Further, the packaging template definition process of the packaging template definition module includes:
defining the area and the position of the product name, specification, packaging form, batch number, production date and effective period in the template for packaging;
defining the area and the position of the packaging operation date and the specific time point in the template for packaging;
defining the area and the position of the signature of the packing operation responsible person in the template for packing;
defining the area and the position of an operator signature of a packaging process in the template for packaging;
defining the area and position of the name, batch number and actual using quantity of each packaging material in the template for packaging;
defining the area and the position of an inspection record carried out according to a process rule in the template for packaging, wherein the inspection record of the process rule comprises an intermediate control result of the process rule;
defining the area and position of the details of the packaging operation in the template for packaging, wherein the details comprise the number of the used equipment and packaging production line;
defining the area and position of the real sample record of the used printing packaging material in the template for packaging, wherein the real sample of the printing packaging material comprises a batch number and a valid period and other printing contents; the printed packaging material which is not easy to be filed along with batch packaging records can adopt a copy printed with the content;
defining the area and the position of the record of special problems and/or abnormal events occurring in the medicine packaging process in the template for packaging;
the name, code, and number of issues, uses, destroys, or refunds, actual production, and material balance checks of all printed packaging materials and products to be packaged are defined as the area and location in the packaging template.
Further, the batch archive generation module comprises:
the production record importing module is used for importing the production process record into the batch archive template by a user; wherein the production process record comprises production data and quality data of each batch of products in the batch of products recorded in the system from formula generation to approval in the clearing field;
the defining module is used for defining the production data and the quality data imported into the batch archive template according to the format of the batch archive template and generating an electronic batch archive;
and the block generation module is used for forming the generated electronic batch file into blocks and recording the blocks to a block chain.
Further, the electronic batch archive generation process of the batch archive generation module includes:
the user imports the production process record into the batch archive template; wherein the production process record comprises production data and quality data of each batch of products in the batch of products recorded in the system from formula generation to approval in the clearing field;
defining the production data and the quality data imported into the batch archive template according to the format of the batch archive template, and generating an electronic batch archive;
and forming a block by the generated electronic batch file, and recording the block onto a block chain.
Further, the process of exporting the batch archive by the batch archive export module comprises the following steps:
step 1, sending a batch file export request to a batch file export module by a block chain link point;
step 2, after receiving a batch file export request sent by the block chain node, the batch file export module scans whether a mark which does not accord with the file export qualification exists in the block chain node which sends the batch file export request; if the mark which does not conform to the file qualification is not available, executing the step 3;
step 3, scanning batch files to derive historical records, and searching whether batch file historical derivation records of the block chain nodes exist or not; if the batch archive export history records of the block chain nodes exist in the batch archive export history records, executing a batch archive export request; if the batch archive historical export records of the block chain nodes do not exist in the batch archive export historical records, calling unit departments corresponding to the block chain nodes;
step 4, comparing the names of the unit departments and the function attributes of the unit departments with a preset unit department list needing to call batch files, and judging whether the unit departments corresponding to the block chain link points currently sending batch file export requests are departments listed in the unit department list or not; if yes, executing the file export request; if the unit department corresponding to the block link point currently sending the batch file export request does not belong to any unit department of the unit department list, executing the step 5;
step 5, the batch file export module continuously sends verification information to a responsible person of a unit department corresponding to the block link point which currently sends the batch file export request according to a preset time interval, requests the responsible person of the unit department to carry out verification reply within a preset specified time, and provides identity information; the number of times of continuously sending the verification information is 3, and the specified time takes the time point corresponding to the first sending of the verification information as a starting time point; if the responsible person replies to the verification information within the preset specified time, executing the step 6; if the responsible person does not reply to the verification information within the preset specified time, executing step 7;
step 6, recording the verification reply process, recording the identity information replied by the responsible person, and executing a file export request after the batch file export module completes the recording and the identity information recording;
and 7, not executing the file export request, and marking the block chain nodes which do not conform to the file qualification.
Further, the process of exporting the batch archive by the batch archive export module further comprises:
when the batch file exporting module scans the block chain nodes and has marks which do not accord with the file typing qualification, the batch file exporting module adjusts the preset time interval and the preset specified time according to a time interval adjusting model and a specified time adjusting model respectively to obtain the adjusted time interval and the regulated time, wherein the time interval adjusting model is as follows;
Figure BDA0002782953150000051
wherein, TcIndicating the adjusted time interval, Tc0Representing a preset time interval; n represents the number of times that verification is completed and the batch file export module executes file export to the block chain link point in the number of subsequent batch file export requests after the block chain node is marked to meet the file qualification for the first time; t isiRepresenting the time for the responsible person of the department to reply the verification information in the ith verification process in the times of executing file export to the block link point by the batch file export module;
the specified time adjustment model is as follows:
Figure BDA0002782953150000061
wherein, TgIndicates a predetermined time after adjustment, Tg0Representing a preset specified time;
continuously sending verification information to a responsible person of a unit department corresponding to the block link point which currently sends the batch file export request according to the adjusted time interval, requesting the responsible person of the unit department to perform verification reply within the adjusted specified time, and providing identity information; the number of times of continuously sending the verification information is 5, and the regulated specified time takes the time point corresponding to the last time of sending the verification information as a starting time point;
if the responsible person replies the verification information within the regulated specified time, recording the verification reply process, recording the identity information replied by the responsible person, and executing a file export request after the batch file export module finishes recording and identity information recording;
if the person in charge does not reply the verification information within the regulated specified time, the file export request is not executed, and the marking which does not conform to the file qualification is carried out on the block chain node again;
and when the number of marks which do not conform to the file output qualification and appear on the block chain nodes exceeds a specified number threshold, blocking the block chain nodes, wherein the batch file output module does not accept batch file output requests sent by the block chain nodes any more and prompts the department responsible persons to go to relevant departments to carry out manual verification unblocking.
The invention has the beneficial effects that:
the block chain-based drug batch archive tracing system provided by the invention can record batch archives in the drug production process, and information such as people, machines, materials, methods, rings, tests and the like in each batch of drug production process is recorded on the block chain so as to realize tracing. Based on block chain tracing, the system can ensure that all medicine information is not falsified and provide accurate and usable information for quality tracing, thereby effectively improving the authenticity of tracing the medicine batch file information; in addition, the tracing system can inquire information and analyze the information according to multiple dimensions, and tracing efficiency is effectively improved.
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FIG. 1 is a schematic diagram of the system of the present invention;
fig. 2 is a schematic diagram of the system of the present invention.
Detailed Description
The preferred embodiments of the present invention will be described in conjunction with the accompanying drawings, and it will be understood that they are described herein for the purpose of illustration and explanation and not limitation.
The invention provides a block chain-based drug batch file tracing system, which is used for solving the problems that the existing drug production tracing system is low in working efficiency and cannot trace the authenticity of information, and adopts the following technical scheme:
as shown in fig. 1 and 2, the system for tracing a batch file of a medicine based on a block chain according to the present invention includes:
the template definition module is used for defining and setting the content and the format of the batch file template according to the requirement and generating a batch file template; the batch archive template comprises a production template and a packaging template.
The batch file generation module is used for generating an electronic batch file in the drug production process according to the record content of the drug production process and the content and format of a batch file template, and issuing the electronic batch file to a block chain;
the batch file export module is used for exporting the generated electronic batch files on each node of the block chain;
the batch file transfer module is used for transferring the generated electronic batch files on each node of the block chain;
and the batch file query module is used for querying the generated electronic batch files on each node of the block chain.
Wherein the batch archive generation module comprises:
the production record importing module is used for importing the production process record into the batch archive template by a user; wherein the production process record comprises production data and quality data of each batch of products in the batch of products recorded in the system from formula generation to approval in the clearing field;
the defining module is used for defining the production data and the quality data imported into the batch archive template according to the format of the batch archive template and generating an electronic batch archive;
and the block generation module is used for forming the generated electronic batch file into blocks and recording the blocks to a block chain.
And the electronic batch archive generation process of the batch archive generation module comprises the following steps:
firstly, a user imports a production process record into the batch archive template; wherein the production process record comprises production data and quality data of each batch of products in the batch of products recorded in the system from formula generation to approval in the clearing field;
secondly, defining the production data and the quality data imported into the batch archive template according to the format of the batch archive template, and generating an electronic batch archive;
and thirdly, forming a block from the generated electronic batch file and recording the block to a block chain.
The production template and the packaging template comprise the following contents:
1) the contents of the batch production record include: product name, specification, lot number; date and time of production and intermediate process start and end; monitoring and recording the environment; signing by a person in charge of each production process; signature of operators in the production step; if necessary, there should be the signature of the operator (e.g. weighing) and rechecking personnel; the batch number of each raw and auxiliary material and the actual weighed quantity (including the batch number and the quantity of the input recycling or rework processing products); relevant production operations or activities, process parameters and control ranges, and the number of the production equipment used; recording the intermediate control result and signing by an operator; calculating the yield obtained in different production processes and material balance when necessary; recording of special problems or exceptional events.
2) The contents of the batch package record include: product name, specification, packaging form, batch number, production date and expiration date; date and time of the packaging operation; the person in charge of the packaging operation signs; operator signature of the packaging process; the name, lot number and actual quantity used of each packaging material; checking records according to the process rules, including intermediate control results; details of the packaging operations, including the equipment used and the numbering of the packaging lines; the used printing packaging material is a real sample, and is printed with batch numbers, validity periods and other printing contents; the printed packaging material which is not easy to be filed along with batch packaging records can adopt a copy printed with the content; recording of special problems or abnormal events; the name, code of all printed packaging materials and products to be packaged, and the number of dispenses, uses, destroys or refunds, actual production and material balance checks.
The working principle of the technical scheme is as follows: the block chain-based drug batch archive tracing system firstly utilizes a template definition module to define and set the content and format of a batch archive template according to the requirement and generates a batch archive template; the batch archive template comprises a production template and a packaging template. Then, generating an electronic batch file in the drug production process by using a batch file generation module according to the record content of the drug production process and the content and format of a batch file template, and publishing the electronic batch file to a block chain; finally, in the later tracing system operation process, a user can export the generated electronic batch files on each node of the block chain through a batch file export module of the system according to requirements; or, the generated electronic batch files are transferred on each node of the block chain through a batch file transfer module; or, the generated electronic batch file is inquired on each node of the block chain through the batch file inquiry module. The blockchain node may be a network device on each node corresponding to the blockchain network.
The effect of the above technical scheme is as follows: batch files in the drug production process can be recorded, and information such as people, machines, materials, methods, rings, tests and the like in each batch of drug production process is recorded on the block chain so as to realize tracing. Based on block chain tracing, the system can ensure that all medicine information is not falsified and provide accurate and usable information for quality tracing, thereby effectively improving the authenticity of tracing the medicine batch file information; in addition, the tracing system can inquire information and analyze the information according to multiple dimensions, and tracing efficiency is effectively improved.
In one embodiment of the invention, the template definition module comprises a production template definition module and a packaging template definition module;
the production template definition module is used for defining the content items of the production template and the size and the position of the area where the content items are located;
and the template definition module for packaging is used for defining the content items of the template for packaging and the size and the position of the area where the content items are located.
Wherein the production template definition module comprises:
the name specification definition module is used for defining the recording areas and positions of the product name, specification and batch number in the production template;
the time definition module is used for defining the start and end dates and specific time points in the drug production process, and the start and end dates and specific time points of each intermediate process in the drug production process in the areas and positions of the production templates;
the environment definition module is used for defining the area and the position of the environment monitoring record of the drug production in the production template;
the signature definition module is used for defining the area and the position of the signature of a person in charge of each production process in the production template; and defining the signature of the operator in the production step, and/or defining the area and the position of the signature of the operator in the production template;
the raw and auxiliary material defining module is used for defining the area and the position of the batch number and the actual weighing quantity of each raw and auxiliary material in the production template; wherein the batch number and the actual weighed quantity of the raw and auxiliary materials comprise the batch number and the quantity of the input recycling or reworking treatment products;
the operation activity definition module is used for defining related production operation or activity, process parameters and control range in the drug production process, and the area and position of the serial number of the used production equipment in the production template; (ii) a
The intermediate result definition module is used for defining the record of an intermediate control result in the drug production process and the area and the position of the signature of an operator in the production template;
the yield and material calculation process result definition module is used for defining the yield obtained by different production processes and the area and the position of the material balance calculation process and result in the production template when necessary;
and the abnormity definition module is used for defining the area and the position of the record of the special problems and/or abnormal events in the production process of the medicine bottles in the production template.
The template definition module for packaging includes:
the product definition module is used for defining the area and the position of the product name, the specification, the packaging form, the batch number, the production date and the validity period in the template for packaging;
the operation time definition module is used for defining the area and the position of the packaging operation date and the specific time point in the template for packaging;
the first signature definition module is used for defining the area and the position of the signature of a person in charge of the packaging operation in the template for packaging;
a second signature definition module for defining the region and the position of the signature of the operator in the packaging procedure in the template;
the packaging material definition module is used for defining the area and the position of the name, the batch number and the actually used quantity of each packaging material in the template for packaging;
the process definition module is used for defining the area and the position of an inspection record carried out according to a process rule in the template for packaging, wherein the inspection record of the process rule comprises an intermediate control result of the process rule;
an operation definition module, which is used for defining the area and the position of the detailed condition of the packaging operation in the template for packaging, wherein the detailed condition comprises the number of the used equipment and the packaging production line;
the printing definition module is used for defining the area and the position of the real sample of the used printing packaging material recorded in the template for packaging, wherein the real sample of the printing packaging material comprises a batch number and a valid period which are printed and other printing contents; the printed packaging material which is not easy to be filed along with batch packaging records can adopt a copy printed with the content;
the abnormal condition definition module is used for defining the area and the position of a record of a special problem and/or an abnormal event which occur in the medicine packaging process in the template for packaging;
and the other content definition module is used for defining the names and codes of all printed packaging materials and products to be packaged, and the areas and positions of the issuing, using, destroying or returning libraries, the actual yield and the material balance check in the template for packaging.
The working principle of the technical scheme is as follows: the template definition module comprises two definition modules, namely a production template definition module and a packaging template definition module, and respectively defines the size and the position of the content item and the area where the content item is located of the production template and the packaging template; the production template definition module defines the recording areas and positions of product names, specifications and batch numbers in the production template through the name specification definition module in the template definition process; defining the start and end dates and specific time points in the drug production process, and the start and end dates and specific time points of each intermediate process in the drug production process in the area and the position of the production template through a time definition module; defining the area and the position of an environment monitoring record of drug production in the production template through an environment definition module; defining the region and the position of the signature of a person in charge of each production process in the production template by adopting a signature definition module; and defining the signature of the operator in the production step, and/or defining the area and the position of the signature of the operator in the production template; defining the area and the position of the batch number and the actual weighed quantity of each raw and auxiliary material in the production template by adopting a raw and auxiliary material definition module; wherein the batch number and the actual weighed quantity of the raw and auxiliary materials comprise the batch number and the quantity of the input recycling or reworking treatment products; defining related production operation or activity, process parameters and control range in the drug production process by using an operation activity definition module, and defining the area and the position of the serial number of the used production equipment in the production template; defining the record of the intermediate control result and the area and the position of the signature of an operator in the production template in the drug production process by adopting an intermediate result definition module; defining the areas and positions of the yield obtained by different production processes and the material balance calculation process and result in the production template as necessary by a yield and material calculation process result definition module; and defining the area and the position of the record of the special problems and/or abnormal events in the production template in the production process of the medicine bottle by using an abnormality definition module.
The packaging template definition module defines the area and the position of the product name, specification, packaging form, batch number, production date and effective period in the packaging template through the product definition module; defining the area and the position of a packaging operation date and a specific time point in the template for packaging by adopting a time definition module; defining the region and the position of the signature of a person in charge of the packaging operation in the template for packaging through a signature definition module; defining the area and the position of the operator signature in the packaging template in the packaging process through a signature definition module II; defining the area and the position of the name, the batch number and the actually used quantity of each packaging material in the template for packaging by using a packaging material definition module; defining areas and positions of inspection records according to a process rule in the template for packaging by using a process definition module, wherein the inspection records of the process rule comprise intermediate control results of the process rule; defining the area and the position of the details of the packaging operation in the template for packaging through an operation definition module, wherein the details comprise the numbers of used equipment and packaging production lines; defining the area and the position of a real sample of the used printing packaging material recorded in the template for packaging by using a printing definition module, wherein the real sample of the printing packaging material comprises a batch number and a valid period which are printed and other printing contents; wherein, the printing packaging material which is not easy to be filed along with batch packaging records can adopt the copy printed with the content; defining the area and the position of a record of a special problem and/or an abnormal event occurring in the medicine packaging process in the template for packaging through an abnormal condition definition module; other content definition modules are used to define the names, codes of all printed packaging materials and products to be packaged, and the number of issuing, using, destroying or returning banks, the actual production and material balance check areas and positions in the packaging templates.
The effect of the above technical scheme is as follows: firstly, the batch file template is divided into a production template and a packaging template, and the production template definition module and the packaging template definition module are arranged to record and retain information of all processes of medicine production and packaging, so that the information content in the medicine production process is increased. Comprehensive medicine information data are provided for follow-up medicine information tracing, and follow-up information tracing efficiency is improved.
In an embodiment of the present invention, the production template definition process of the production template definition module includes:
step A1, defining the recording area and position of the product name, specification and batch number in the production template;
step A2, defining the start and end dates and specific time points in the drug production process, and the start and end dates and specific time points of each intermediate process in the drug production process in the areas and positions of the production templates;
step A3, defining the area and the position of the environment monitoring record of the drug production in the production template;
step A4, defining the area and the position of the responsible person signature of each production process in the production template; and defining the signature of the operator in the production step, and/or defining the area and the position of the signature of the operator in the production template;
step A5, defining the area and the position of the batch number and the actual weighed quantity of each raw and auxiliary material in the production template; wherein the batch number and the actual weighed quantity of the raw and auxiliary materials comprise the batch number and the quantity of the input recycling or reworking treatment products;
step A6, defining relevant production operation or activity, process parameters and control range in the drug production process, and the area and position of the serial number of the used production equipment in the production template; (ii) a
Step A7, defining the area and the position of the record of the intermediate control result and the signature of the operator in the production template in the drug production process;
step A8, defining the areas and positions of the yields and material balance calculation processes and results in the production templates;
step a9 defines the areas and locations in the production template for records of special problems and/or abnormal events that occur during the vial production process.
Wherein, the packaging template definition process of the packaging template definition module comprises the following steps:
step B1, defining the area and the position of the product name, the specification, the packaging form, the batch number, the production date and the valid period in the template for packaging;
step B2, defining the area and the position of the packaging operation date and the specific time point in the template for packaging;
step B3, defining the area and the position of the signature of the person in charge of the packaging operation in the template for packaging;
step B4, defining the area and the position of the operator signature of the packaging process in the template for packaging;
step B5, defining the area and the position of the name, the batch number and the actual using quantity of each packaging material in the template for packaging;
step B6, defining the area and the position of the inspection record in the template for packaging according to the process regulation, wherein the inspection record of the process regulation comprises the intermediate control result of the process regulation;
step B7, defining the area and the position of the details of the packaging operation in the template for packaging, wherein the details comprise the number of the used equipment and the packaging production line;
step B8, defining the area and position of the real sample of the printing packaging material recorded in the template for packaging, wherein the real sample of the printing packaging material comprises a batch number and a valid period and other printing contents; the printed packaging material which is not easy to be filed along with batch packaging records can adopt a copy printed with the content;
step B9, defining the area and the position of the record of the special problems and/or abnormal events in the medicine packaging process in the template for packaging;
step B10, defining the name, code of all printed packaging material and product to be packaged, and the number of issuing, using, destroying or returning banks, actual production and material balance checks the area and location in the packaging template.
The effect of the above technical scheme is as follows: by defining the area size and the area position of the production template and the packaging template in the steps and the sequence, the template generation efficiency can be effectively improved. Meanwhile, the template definition is carried out according to the sequence of the steps generated by the template, the regions and the positions of the contents can be arranged and set in sequence according to the importance degree of the information data, reasonable position arrangement and comprehensive recording of information such as people, machines, materials, methods, rings, measurements and the like in the production process of each batch of medicines are realized, the definition sequence of each content item defined in the production template and the packaging template and the setting of the regions and the positions are matched with the actual programs of the production process and the packaging process, and the efficiency of batch file generation by using the corresponding template in the production and packaging processes of the medicines is improved. Meanwhile, the reasonability of arrangement and setting of the areas and the positions of the contents is improved, and the problems that the file contents are disordered and are not easy to look up due to unreasonable arrangement of the areas and the positions of the content items are avoided.
In an embodiment of the present invention, the process of exporting the batch archive by the batch archive export module includes:
step 1, sending a batch file export request to a batch file export module by a block chain link point;
step 2, after receiving a batch file export request sent by the block chain node, the batch file export module scans whether a mark which does not accord with the file export qualification exists in the block chain node which sends the batch file export request; if the mark which does not conform to the file qualification is not available, executing the step 3;
step 3, scanning batch files to derive historical records, and searching whether batch file historical derivation records of the block chain nodes exist or not; if the batch archive export history records of the block chain nodes exist in the batch archive export history records, executing a batch archive export request; if the batch archive historical export records of the block chain nodes do not exist in the batch archive export historical records, calling unit departments corresponding to the block chain nodes;
step 4, comparing the names of the unit departments and the function attributes of the unit departments with a preset unit department list needing to call batch files, and judging whether the unit departments corresponding to the block chain link points currently sending batch file export requests are departments listed in the unit department list or not; if yes, executing the file export request; if the unit department corresponding to the block link point currently sending the batch file export request does not belong to any unit department of the unit department list, executing the step 5;
step 5, the batch file export module continuously sends verification information to a responsible person of a unit department corresponding to the block link point which currently sends the batch file export request according to a preset time interval, requests the responsible person of the unit department to carry out verification reply within a preset specified time, and provides identity information; the number of times of continuously sending the verification information is 3, and the specified time takes the time point corresponding to the first sending of the verification information as a starting time point; if the responsible person replies to the verification information within the preset specified time, executing the step 6; if the responsible person does not reply to the verification information within the preset specified time, executing step 7; wherein the preset time interval is 30min, and the preset specified time is 3 hours;
step 6, recording the verification reply process, recording the identity information replied by the responsible person, and executing a file export request after the batch file export module completes the recording and the identity information recording;
and 7, not executing the file export request, and marking the block chain nodes which do not conform to the file qualification.
Wherein, the process of exporting the batch archive by the batch archive export module further comprises:
when the batch file exporting module scans the block chain nodes and has marks which do not accord with the file typing qualification, the batch file exporting module adjusts the preset time interval and the preset specified time according to a time interval adjusting model and a specified time adjusting model respectively to obtain the adjusted time interval and the regulated time, wherein the time interval adjusting model is as follows;
Figure BDA0002782953150000131
wherein, TcIndicating the adjusted time interval, Tc0Representing a preset time interval; n represents the number of times that verification is completed and the batch file export module executes file export to the block chain link point in the number of subsequent batch file export requests after the block chain node is marked to meet the file qualification for the first time; t isiRepresenting the time for the responsible person of the department to reply the verification information in the ith verification process in the times of executing file export to the block link point by the batch file export module;
the specified time adjustment model is as follows:
Figure BDA0002782953150000132
wherein, TgIndicates a predetermined time after adjustment, Tg0Representing a preset specified time;
continuously sending verification information to a responsible person of a unit department corresponding to the block link point which currently sends the batch file export request according to the adjusted time interval, requesting the responsible person of the unit department to perform verification reply within the adjusted specified time, and providing identity information; the number of times of continuously sending the verification information is 5, and the regulated specified time takes the time point corresponding to the last time of sending the verification information as a starting time point;
if the responsible person replies the verification information within the regulated specified time, recording the verification reply process, recording the identity information replied by the responsible person, and executing a file export request after the batch file export module finishes recording and identity information recording;
if the person in charge does not reply the verification information within the regulated specified time, the file export request is not executed, and the marking which does not conform to the file qualification is carried out on the block chain node again;
and when the number of marks which do not conform to the file output qualification and appear on the block chain nodes exceeds a specified number threshold, blocking the block chain nodes, wherein the batch file output module does not accept batch file output requests sent by the block chain nodes any more and prompts the department responsible persons to go to relevant departments to carry out manual verification unblocking.
The working principle of the technical scheme is as follows:
firstly, a block chain node sends a batch file export request to the batch file export module; after receiving a batch file export request sent by the block chain node, the batch file export module scans whether a mark which does not accord with file export qualification exists in the block chain node which sends the batch file export request; if the mark which does not conform to the file typing qualification does not exist, scanning batch files to derive historical records, and searching whether the batch file historical derivation record of the block chain node exists or not; if the batch archive export history records of the block chain nodes exist in the batch archive export history records, executing a batch archive export request; if the batch archive historical export records of the block chain nodes do not exist in the batch archive export historical records, calling unit departments corresponding to the block chain nodes;
comparing the name of the unit department and the function attribute of the unit department with a preset unit department list needing to call batch files, and judging whether the unit department corresponding to the block link point currently sending the batch file export request is a department listed in the unit department list; if yes, executing the file export request; if the unit department corresponding to the block link point which sends the batch file export request currently does not belong to any unit department of the unit department list, the batch file export module continuously sends verification information to a responsible person of the unit department corresponding to the block link point which sends the batch file export request currently according to a preset time interval, requests the responsible person of the unit department to carry out verification reply within a preset specified time, and provides identity information; the number of times of continuously sending the verification information is 3, and the specified time takes the time point corresponding to the first sending of the verification information as a starting time point; if the responsible person replies the verification information within the preset specified time, recording the verification reply process, recording the identity information replied by the responsible person, and executing a file export request after the batch file export module finishes recording and identity information recording; if the responsible person does not reply the verification information within the preset specified time, the file export request is not executed, and the block chain node is marked as being not qualified for the file typing; wherein the preset time interval is 30min, and the preset specified time is 3 hours;
when the batch file exporting module scans the mark of the block chain node which does not accord with the file typing qualification, the batch file exporting module adjusts the preset time interval and the preset specified time according to a time interval adjusting model and a specified time adjusting model respectively to obtain the adjusted time interval and the regulated time,
continuously sending verification information to a responsible person of a unit department corresponding to the block link point which currently sends the batch file export request according to the adjusted time interval, requesting the responsible person of the unit department to perform verification reply within the adjusted specified time, and providing identity information; the number of times of continuously sending the verification information is 5, and the regulated specified time takes the time point corresponding to the last time of sending the verification information as a starting time point;
if the responsible person replies the verification information within the regulated specified time, recording the verification reply process, recording the identity information replied by the responsible person, and executing a file export request after the batch file export module finishes recording and identity information recording;
if the person in charge does not reply the verification information within the regulated specified time, the file export request is not executed, and the marking which does not conform to the file qualification is carried out on the block chain node again;
and when the number of marks which do not conform to the file output qualification and appear on the block chain nodes exceeds a specified number threshold, blocking the block chain nodes, wherein the batch file output module does not accept batch file output requests sent by the block chain nodes any more and prompts the department responsible persons to go to relevant departments to carry out manual verification unblocking.
The effect of the above technical scheme is as follows: through the verification process of the block chain link points, the data security of the drug batch archives can be effectively improved, and the drugs batch archives are effectively prevented from being stolen through the nodes in the block chain network. Meanwhile, through the setting of the time interval and the specified time, the efficient safety verification and monitoring of the block chain link points can be guaranteed, the normal operation work of corresponding unit departments can be guaranteed not to be influenced, the interference and the time delay of the normal work flow of the unit departments are reduced, and the work efficiency of all the departments through the traceability system is improved. Meanwhile, the time interval and the regulated time can be adjusted by fully combining the historical records of each unit department in the actual verification process, the work rhythm of the responsible person of each unit department can be indirectly acquired and referred through the time period of the verification reply of the responsible person of each unit department, and the time interval and the regulated time can be adjusted through the actual verification condition, so that the problem of blockage caused by the fact that the responsible person cannot perform verification in time under the busy condition due to the fixed time interval and the regulated time can be prevented. The normal work of corresponding department of unit is avoided being influenced. The verification process of the batch file export module can be matched with the actual operation condition of each unit department, and the efficiency of information tracing and query is further improved.
It will be apparent to those skilled in the art that various changes and modifications may be made in the present invention without departing from the spirit and scope of the invention. Thus, if such modifications and variations of the present invention fall within the scope of the claims of the present invention and their equivalents, the present invention is also intended to include such modifications and variations.

Claims (10)

1. A blockchain-based drug lot profile traceability system, the system comprising:
the template definition module is used for defining and setting the content and the format of the batch file template according to the requirement and generating a batch file template;
the batch file generation module is used for generating an electronic batch file in the drug production process according to the record content of the drug production process and the content and format of a batch file template, and issuing the electronic batch file to a block chain;
the batch file export module is used for exporting the generated electronic batch files on each node of the block chain;
the batch file transfer module is used for transferring the generated electronic batch files on each node of the block chain;
and the batch file query module is used for querying the generated electronic batch files on each node of the block chain.
2. The system of claim 1, wherein the template definition module comprises a production template definition module and a packaging template definition module, and the batch archive template comprises a production template and a packaging template;
the production template definition module is used for defining the content items of the production template and the size and the position of the area where the content items are located;
and the template definition module for packaging is used for defining the content items of the template for packaging and the size and the position of the area where the content items are located.
3. The system of claim 2, wherein the production template definition module comprises:
the name specification definition module is used for defining the recording areas and positions of the product name, specification and batch number in the production template;
the time definition module is used for defining the start and end dates and specific time points in the drug production process, and the start and end dates and specific time points of each intermediate process in the drug production process in the areas and positions of the production templates;
the environment definition module is used for defining the area and the position of the environment monitoring record of the drug production in the production template;
the signature definition module is used for defining the area and the position of the signature of a person in charge of each production process in the production template; and defining the signature of the operator in the production step, and/or defining the area and the position of the signature of the operator in the production template;
the raw and auxiliary material defining module is used for defining the area and the position of the batch number and the actual weighing quantity of each raw and auxiliary material in the production template; wherein the batch number and the actual weighed quantity of the raw and auxiliary materials comprise the batch number and the quantity of the input recycling or reworking treatment products;
the operation activity definition module is used for defining related production operation or activity, process parameters and control range in the drug production process, and the area and position of the serial number of the used production equipment in the production template; (ii) a
The intermediate result definition module is used for defining the record of an intermediate control result in the drug production process and the area and the position of the signature of an operator in the production template;
the yield and material calculation process result definition module is used for defining the yield obtained by different production processes and the area and the position of the material balance calculation process and result in the production template when necessary;
and the abnormity definition module is used for defining the area and the position of the record of the special problems and/or abnormal events in the production process of the medicine bottles in the production template.
4. The system of claim 2, wherein the production template definition process of the production template definition module comprises:
defining the recording area and position of the product name, specification and batch number in the production template;
defining the start and end dates and specific time points in the drug production process, and the start and end dates and specific time points of each intermediate process in the drug production process in the area and the position of each intermediate process in the production template;
defining the area and the position of the environment monitoring record of the drug production in the production template;
defining the area and the position of a responsible person signature of each production process in the production template; and defining the signature of the operator in the production step, and/or defining the area and the position of the signature of the operator in the production template;
defining the area and the position of the batch number and the actual weighed quantity of each raw and auxiliary material in the production template; wherein the batch number and the actual weighed quantity of the raw and auxiliary materials comprise the batch number and the quantity of the input recycling or reworking treatment products;
defining related production operation or activity, process parameters and control range in the production process of the medicine, and the area and the position of the serial number of the used production equipment in the production template; (ii) a
Defining the area and the position of the record of the intermediate control result and the signature of an operator in the production template in the drug production process;
defining the yield obtained by different production processes and the area and the position of the material balance calculation process and the result in the production template when necessary;
defining the areas and locations in the production template of records of special problems and/or abnormal events that occur during the production of the vials.
5. The system of claim 2, wherein the packaging template definition module comprises:
the product definition module is used for defining the area and the position of the product name, the specification, the packaging form, the batch number, the production date and the validity period in the template for packaging;
the operation time definition module is used for defining the area and the position of the packaging operation date and the specific time point in the template for packaging;
the first signature definition module is used for defining the area and the position of the signature of a person in charge of the packaging operation in the template for packaging;
a second signature definition module for defining the region and the position of the signature of the operator in the packaging procedure in the template;
the packaging material definition module is used for defining the area and the position of the name, the batch number and the actually used quantity of each packaging material in the template for packaging;
the process definition module is used for defining the area and the position of an inspection record carried out according to a process rule in the template for packaging, wherein the inspection record of the process rule comprises an intermediate control result of the process rule;
an operation definition module, which is used for defining the area and the position of the detailed condition of the packaging operation in the template for packaging, wherein the detailed condition comprises the number of the used equipment and the packaging production line;
the printing definition module is used for defining the area and the position of a real sample of the used printing packaging material recorded in the template for packaging, wherein the real sample of the printing packaging material comprises a printed batch number and a valid period;
the abnormal condition definition module is used for defining the area and the position of a record of a special problem and/or an abnormal event which occur in the medicine packaging process in the template for packaging;
and the other content definition module is used for defining the names and codes of all printed packaging materials and products to be packaged, and the areas and positions of the issuing, using, destroying or returning libraries, the actual yield and the material balance check in the template for packaging.
6. The system of claim 2, wherein the packaging template definition process of the packaging template definition module comprises:
defining the area and the position of the product name, specification, packaging form, batch number, production date and effective period in the template for packaging;
defining the area and the position of the packaging operation date and the specific time point in the template for packaging;
defining the area and the position of the signature of the packing operation responsible person in the template for packing;
defining the area and the position of an operator signature of a packaging process in the template for packaging;
defining the area and position of the name, batch number and actual using quantity of each packaging material in the template for packaging;
defining the area and the position of an inspection record carried out according to a process rule in the template for packaging, wherein the inspection record of the process rule comprises an intermediate control result of the process rule;
defining the area and position of the details of the packaging operation in the template for packaging, wherein the details comprise the number of the used equipment and packaging production line;
defining the area and position of the real sample record of the used printing packaging material in the template for packaging, wherein the real sample of the printing packaging material comprises a batch number and a valid period and other printing contents; the printed packaging material which is not easy to be filed along with batch packaging records can adopt a copy printed with the content;
defining the area and the position of the record of special problems and/or abnormal events occurring in the medicine packaging process in the template for packaging;
the name, code, and number of issues, uses, destroys, or refunds, actual production, and material balance checks of all printed packaging materials and products to be packaged are defined as the area and location in the packaging template.
7. The system of claim 1, wherein the batch archive generation module comprises:
the production record importing module is used for importing the production process record into the batch archive template by a user; wherein the production process record comprises production data and quality data of each batch of products in the batch of products recorded in the system from formula generation to approval in the clearing field;
the defining module is used for defining the production data and the quality data imported into the batch archive template according to the format of the batch archive template and generating an electronic batch archive;
and the block generation module is used for forming the generated electronic batch file into blocks and recording the blocks to a block chain.
8. A system as recited in claim 1, wherein the electronic batch archive generation process of the batch archive generation module comprises:
the user imports the production process record into the batch archive template; wherein the production process record comprises production data and quality data of each batch of products in the batch of products recorded in the system from formula generation to approval in the clearing field;
defining the production data and the quality data imported into the batch archive template according to the format of the batch archive template, and generating an electronic batch archive;
and forming a block by the generated electronic batch file, and recording the block onto a block chain.
9. The system of claim 1, wherein the batch archive export module performs a batch archive export process comprising:
step 1, sending a batch file export request to a batch file export module by a block chain link point;
step 2, after receiving a batch file export request sent by the block chain node, the batch file export module scans whether a mark which does not accord with the file export qualification exists in the block chain node which sends the batch file export request; if the mark which does not conform to the file qualification is not available, executing the step 3;
step 3, scanning batch files to derive historical records, and searching whether batch file historical derivation records of the block chain nodes exist or not; if the batch archive export history records of the block chain nodes exist in the batch archive export history records, executing a batch archive export request; if the batch archive historical export records of the block chain nodes do not exist in the batch archive export historical records, calling unit departments corresponding to the block chain nodes;
step 4, comparing the names of the unit departments and the function attributes of the unit departments with a preset unit department list needing to call batch files, and judging whether the unit departments corresponding to the block chain link points currently sending batch file export requests are departments listed in the unit department list or not; if yes, executing the file export request; if the unit department corresponding to the block link point currently sending the batch file export request does not belong to any unit department of the unit department list, executing the step 5;
step 5, the batch file export module continuously sends verification information to a responsible person of a unit department corresponding to the block link point which currently sends the batch file export request according to a preset time interval, requests the responsible person of the unit department to carry out verification reply within a preset specified time, and provides identity information; the number of times of continuously sending the verification information is 3, and the specified time takes the time point corresponding to the first sending of the verification information as a starting time point; if the responsible person replies to the verification information within the preset specified time, executing the step 6; if the responsible person does not reply to the verification information within the preset specified time, executing step 7; wherein the preset time interval is 30min, and the preset specified time is 3 hours;
step 6, recording the verification reply process, recording the identity information replied by the responsible person, and executing a file export request after the batch file export module completes the recording and the identity information recording;
and 7, not executing the file export request, and marking the block chain nodes which do not conform to the file qualification.
10. The system of claim 1, wherein the process of batch archive export by the batch archive export module further comprises:
when the batch file exporting module scans the block chain nodes and has marks which do not accord with the file typing qualification, the batch file exporting module adjusts the preset time interval and the preset specified time according to a time interval adjusting model and a specified time adjusting model respectively to obtain the adjusted time interval and the regulated time, wherein the time interval adjusting model is as follows;
Figure FDA0002782953140000051
wherein, TcIndicating the adjusted time interval, Tc0Representing a preset time interval; n represents the number of times that verification is completed and the batch file export module executes file export to the block chain link point in the number of subsequent batch file export requests after the block chain node is marked to meet the file qualification for the first time; t isiRepresenting the time for the responsible person of the department to reply the verification information in the ith verification process in the times of executing file export to the block link point by the batch file export module;
the specified time adjustment model is as follows:
Figure FDA0002782953140000052
wherein, TgIndicates a predetermined time after adjustment, Tg0Representing a preset specified time;
continuously sending verification information to a responsible person of a unit department corresponding to the block link point which currently sends the batch file export request according to the adjusted time interval, requesting the responsible person of the unit department to perform verification reply within the adjusted specified time, and providing identity information; the number of times of continuously sending the verification information is 5, and the regulated specified time takes the time point corresponding to the last time of sending the verification information as a starting time point;
if the responsible person replies the verification information within the regulated specified time, recording the verification reply process, recording the identity information replied by the responsible person, and executing a file export request after the batch file export module finishes recording and identity information recording;
if the person in charge does not reply the verification information within the regulated specified time, the file export request is not executed, and the marking which does not conform to the file qualification is carried out on the block chain node again;
and when the number of marks which do not conform to the file output qualification and appear on the block chain nodes exceeds a specified number threshold, blocking the block chain nodes, wherein the batch file output module does not accept batch file output requests sent by the block chain nodes any more and prompts the department responsible persons to go to relevant departments to carry out manual verification unblocking.
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