Pharmaceutical production quality management method and system based on industrial data processing

Abstract

The present invention provides a drug production quality management method and system based on industrial data processing, which relates to the technical field of drug quality management. The method includes: obtaining sample drug raw materials; determining organic impurity content, inorganic impurity content, residual solvent content and raw material active ingredient content; determining drug raw material quality score; determining environmental data of drug production area; determining working parameters of production equipment; determining drug production working environment score; obtaining finished drug products to be tested, determining active ingredient content, microbial quantity and impurity content of the finished drug products to be tested; obtaining drug active ingredient content and degradation product content of the finished drug products to be tested; determining drug finished product quality score according to active ingredient content, microbial quantity, impurity content, drug active ingredient content and degradation product content; generating drug production quality management report. According to the present invention, the comprehensiveness and accuracy of drug production quality management can be improved.

Description

Technical Field

[0001] The present invention relates to the technical field of drug quality management, and in particular to a drug production quality management method and system based on industrial data processing. Background Art

[0002] In the related technology, CN113506046B discloses a drug quality control analysis system based on quality management specification data tracking, including a tablet production process statistics module, a production process production monitoring terminal setting module, a production process production operation parameter collection module, a production process production environment parameter collection module, a tablet finished product appearance morphology parameter collection module, a quality modeling analysis module, a production quality database and a quality control processing terminal. During the tablet production process, the tablet production process operation specification quality coefficient, the tablet production environment suitability quality coefficient and the tablet finished product appearance morphology quality coefficient are analyzed and counted respectively to comprehensively judge whether the tablet production quality is qualified. When the judgment result is that the tablet production quality is unqualified, the cause of the unqualified is tracked, which effectively makes up for the shortcomings of the current tablet production quality analysis method.

[0003] CN117726227A discloses a deviation management system and method for drug production quality management, and relates to the technical field of drug quality management. The system includes: a deviation identification module, a deviation analysis and evaluation recording module, a deviation review setting module, a deviation review recording module, a deviation investigation plan formulation module, a deviation investigation plan review recording module, a deviation investigation result recording module, a deviation summary recording module, and a deviation summary review recording module. By setting the above modules, the embodiment of the scheme can intelligently realize the data standard recording and review and approval functions in the drug quality deviation management process, so that the drug quality deviation management activities can be quickly circulated among various departments, and the layer-by-layer review and approval can ensure the accuracy of data records, thereby avoiding the problems of non-standard filling of data records, the problem of personnel violating regulations and supplementing records, the problem of personnel being unable to approve in time on business trips / vacations, and the paper qualification filing and storage consuming a lot of manpower and material resources.

[0004] Based on the above related technologies, the quality of drug production can be judged. However, the related technologies do not take into account the impact of the quality of drug raw materials, the drug production working environment and the quality of drug finished products on drug production quality management, that is, it is impossible to comprehensively manage the drug production quality based on the three aspects of drug raw material quality, drug production working environment and drug finished product quality.

[0005] The information disclosed in the background technology section of this application is only intended to deepen the understanding of the general background technology of this application, and should not be regarded as an admission or any form of suggestion that the information constitutes the prior art already known to those skilled in the art. Summary of the invention

[0006] The present invention provides a drug production quality management method and system based on industrial data processing, which can solve the technical problem that related technologies cannot comprehensively manage drug production quality based on three aspects: drug raw material quality, drug production working environment and drug finished product quality.

[0007] According to a first aspect of the present invention, there is provided a method for managing drug production quality based on industrial data processing, comprising:

[0008] Sampling the drug raw materials to obtain sample drug raw materials;

[0009] Through testing instruments, the sample drug raw materials are tested for impurities and effective ingredients to determine the organic impurity content, inorganic impurity content, residual solvent content and effective ingredient content of the sample drug raw materials;

[0010] Determine the quality score of the pharmaceutical raw material according to the organic impurity content, the inorganic impurity content, the residual solvent content and the active ingredient content of the raw material;

[0011] At multiple moments in the management cycle, multiple sensors are arranged at preset positions in the drug production area to collect environmental data of the drug production area, and determine the environmental data of the drug production area, wherein the environmental data includes: light data, dust concentration data, temperature data and relative humidity data;

[0012] At multiple moments in the management cycle, the operating parameters of the production equipment are determined through the production equipment monitoring system, wherein the operating parameters include: operating temperature, operating pressure, stirring power and operating flow rate;

[0013] Determining a pharmaceutical production work environment score based on the environmental data and the work parameters;

[0014] Sampling finished drugs to obtain finished drugs to be tested, and determining the active ingredient content, microbial count and impurity content of the finished drugs to be tested;

[0015] At multiple times during the experimental cycle, accelerated testing is performed on the finished drug to be tested, and the content of the active ingredient and the content of the degradation product of the finished drug to be tested is obtained;

[0016] Determine the quality score of the finished drug product based on the active ingredient content, the number of microorganisms, the impurity content, the drug effective ingredient content and the degradation product content;

[0017] A drug production quality management report is generated based on the drug raw material quality score, the drug production work environment score and the drug finished product quality score.

[0018] According to a second aspect of the present invention, there is provided a drug production quality management system based on industrial data processing, comprising:

[0019] A raw material sampling module is used to sample pharmaceutical raw materials and obtain sample pharmaceutical raw materials;

[0020] The raw material detection module is used to detect impurities and active ingredients of sample drug raw materials through detection instruments to determine the organic impurity content, inorganic impurity content, residual solvent content and active ingredient content of the sample drug raw materials;

[0021] A raw material quality scoring module, used to determine the quality score of the pharmaceutical raw material according to the organic impurity content, the inorganic impurity content, the residual solvent content and the raw material active ingredient content;

[0022] An environmental data collection module is used to collect environmental data of the drug production area at multiple moments in the management cycle through multiple sensors set at preset positions in the drug production area to determine the environmental data of the drug production area, wherein the environmental data includes: light data, dust concentration data, temperature data and relative humidity data;

[0023] The production equipment monitoring module is used to determine the working parameters of the production equipment through the production equipment monitoring system at multiple moments in the management cycle, wherein the working parameters include: working temperature, working pressure, stirring power and working flow rate;

[0024] A working environment scoring module, used to determine a drug production working environment score based on the environmental data and the working parameters;

[0025] A finished product sampling module is used to sample finished drugs, obtain finished drugs to be tested, and determine the active ingredient content, microbial count, and impurity content of the finished drugs to be tested;

[0026] The accelerated test module is used to perform accelerated tests on the finished drug to be tested at multiple times during the test cycle, and obtain the content of the active ingredient and the content of the degradation product of the finished drug to be tested;

[0027] A finished product quality scoring module, used to determine the finished drug product quality score based on the active ingredient content, the number of microorganisms, the impurity content, the drug effective ingredient content and the degradation product content;

[0028] The quality management report module is used to generate a drug production quality management report based on the drug raw material quality score, the drug production work environment score and the drug finished product quality score.

[0029] Technical effect: According to the present invention, the component content of pharmaceutical raw materials and finished pharmaceutical products can be accurately analyzed, and the environmental data of the pharmaceutical production area and the working parameters of the production equipment can be collected. Further, based on the component content of the pharmaceutical raw materials, the quality of the pharmaceutical raw materials is evaluated to obtain the quality score of the pharmaceutical raw materials. Based on the environmental data of the pharmaceutical production area and the working parameters of the production equipment, the pharmaceutical production working environment is evaluated to obtain the pharmaceutical production working environment score. Based on the component content of the finished pharmaceutical products, the quality of the finished pharmaceutical products is evaluated to determine the quality score of the finished pharmaceutical products. The quality of pharmaceutical production can be managed in a targeted manner according to the quality score of the pharmaceutical raw materials, the score of the pharmaceutical production working environment and the quality score of the finished pharmaceutical products, thereby improving the comprehensiveness and accuracy of the management of pharmaceutical production quality. When determining the quality score of the pharmaceutical raw materials, the quality score of the pharmaceutical raw materials can be determined according to the organic impurity content, the inorganic impurity content, the residual solvent content and the content of the active ingredient of the raw materials. During the calculation process, the quality of the pharmaceutical raw materials can be judged from the quality status of a single sample pharmaceutical raw material and the quality status of all pharmaceutical raw materials, thereby improving the comprehensiveness and accuracy of the quality score of the pharmaceutical raw materials. When determining the score of the pharmaceutical production working environment, the score of the pharmaceutical production working environment can be determined based on the real-time working environment vector, the standard working environment vector, the real-time production equipment vector, the standard production equipment vector and the dust concentration data. During the calculation process, the pharmaceutical production working environment can be evaluated from two aspects: the overall pharmaceutical production environment status and the overall working stability of the production equipment, thereby improving the comprehensiveness and accuracy of the score of the pharmaceutical production working environment. When determining the quality score of the finished drug, the quality score of the finished drug can be determined based on the quantity ratio, active ingredient content, microbial quantity, impurity content, drug effective ingredient content, degradation product content, drug effective ingredient content change rate and degradation product content change rate. During the calculation process, the quality of the finished drug can be evaluated from three aspects: drug packaging quality, drug stability status and overall finished drug quality, thereby improving the comprehensiveness and accuracy of the finished drug quality score.

[0030] It should be understood that the above general description and the following detailed description are exemplary and explanatory only and do not limit the present invention. Other features and aspects of the present invention will become more apparent from the following detailed description of exemplary embodiments with reference to the accompanying drawings. BRIEF DESCRIPTION OF THE DRAWINGS

[0031] In order to more clearly illustrate the embodiments of the present invention or the technical solutions in the prior art, the drawings required for use in the embodiments or the description of the prior art will be briefly introduced below. Obviously, the drawings in the following description are only some embodiments of the present invention. For those of ordinary skill in the art, other embodiments can be obtained based on these drawings without creative work.

[0032] Figure 1 A flowchart of a pharmaceutical production quality management method based on industrial data processing according to an embodiment of the present invention is exemplarily shown;

[0033] Figure 2 A block diagram of a pharmaceutical production quality management system based on industrial data processing according to an embodiment of the present invention is exemplarily shown. DETAILED DESCRIPTION

[0034] In order to make the purpose, technical solution and advantages of the embodiments of the present invention clearer, the technical solution in the embodiments of the present invention will be clearly and completely described below in conjunction with the drawings in the embodiments of the present invention. Obviously, the described embodiments are only part of the embodiments of the present invention, not all of the embodiments. Based on the embodiments of the present invention, all other embodiments obtained by ordinary technicians in this field without creative work are within the scope of protection of the present invention.

[0035] The technical solution of the present invention is described in detail with specific embodiments below. The following specific embodiments can be combined with each other, and the same or similar concepts or processes may not be described in detail in some embodiments.

[0036] Figure 1 A flowchart of a method for managing drug production quality based on industrial data processing according to an embodiment of the present invention is exemplarily shown, wherein the method comprises:

[0037] Step S101, sampling the drug raw materials to obtain sample drug raw materials;

[0038] Step S102, using a detection instrument to perform impurity detection and effective component detection on the sample drug raw material, and determine the organic impurity content, inorganic impurity content, residual solvent content and effective component content of the raw material of the sample drug raw material;

[0039] Step S103, determining a quality score of the pharmaceutical raw material according to the organic impurity content, the inorganic impurity content, the residual solvent content and the raw material active ingredient content;

[0040] Step S104, at multiple moments in the management cycle, collecting environmental data of the drug production area through multiple sensors set at preset positions in the drug production area, and determining the environmental data of the drug production area, wherein the environmental data includes: light data, dust concentration data, temperature data and relative humidity data;

[0041] Step S105, determining the operating parameters of the production equipment through the production equipment monitoring system at multiple moments in the management cycle, wherein the operating parameters include: operating temperature, operating pressure, stirring power and operating flow rate;

[0042] Step S106, determining a drug production working environment score according to the environmental data and the working parameters;

[0043] Step S107, sampling the finished drug to obtain the finished drug to be tested, and determining the active ingredient content, microbial count and impurity content of the finished drug to be tested;

[0044] Step S108, performing an accelerated test on the finished drug to be tested at multiple times during the test cycle, and obtaining the drug active ingredient content and degradation product content of the finished drug to be tested;

[0045] Step S109, determining the quality score of the finished drug according to the active ingredient content, the number of microorganisms, the impurity content, the drug effective ingredient content and the degradation product content;

[0046] Step S110, generating a drug production quality management report based on the drug raw material quality score, the drug production work environment score and the drug finished product quality score.

[0047] According to the pharmaceutical production quality management method based on industrial data processing of an embodiment of the present invention, the component content of pharmaceutical raw materials and pharmaceutical finished products can be accurately analyzed, and environmental data of the pharmaceutical production area and the working parameters of the production equipment can be collected. Furthermore, based on the component content of the pharmaceutical raw materials, the quality of the pharmaceutical raw materials is evaluated to obtain a pharmaceutical raw material quality score. Based on the environmental data of the pharmaceutical production area and the working parameters of the production equipment, the pharmaceutical production working environment is evaluated to obtain a pharmaceutical production working environment score. Based on the component content of the finished pharmaceutical products, the quality of the finished pharmaceutical products is evaluated to determine the finished pharmaceutical product quality score. The pharmaceutical production quality can be managed in a targeted manner based on the pharmaceutical raw material quality score, the pharmaceutical production working environment score and the finished pharmaceutical product quality score, thereby improving the comprehensiveness and accuracy of pharmaceutical production quality management.

[0048] According to one embodiment of the present invention, in step S101, sampling is performed in pharmaceutical raw materials to obtain sample pharmaceutical raw materials.

[0049] For example, random sampling is performed in the current batch of pharmaceutical raw materials to obtain sample pharmaceutical raw materials.

[0050] According to one embodiment of the present invention, in step S102, the sample pharmaceutical raw material is subjected to impurity detection and effective ingredient detection by a detection instrument to determine the organic impurity content, inorganic impurity content, residual solvent content and effective ingredient content of the sample pharmaceutical raw material.

[0051] For example, organic impurities (e.g., residues of synthetic raw materials, reaction by-products), inorganic impurities (e.g., heavy metals and inorganic salts) and organic solvents that may remain in the production process may be detected through chromatography. The control of organic impurities is crucial to ensure the purity and safety of drugs. Inorganic impurities may have toxic effects on the human body, and residual solvents may have adverse effects on human health. Quantitative analysis methods (e.g., titration and chromatography) are used to accurately determine the content of active ingredients in the sample drug raw materials to ensure that the sample drug raw materials meet the specified quality standards.

[0052] According to one embodiment of the present invention, in step S103, the quality score of the pharmaceutical raw material is determined based on the organic impurity content, the inorganic impurity content, the residual solvent content and the raw material active ingredient content.

[0053] According to one embodiment of the present invention, step S103 includes: determining the drug material quality score Prm of all drug materials according to formula (1): o ,

[0054]

[0055] Among them, if is the conditional function, α1, α2, α3 and α4 are preset weights, OC i is the organic impurity content of the i-th sample drug raw material, OC T To preset the organic impurity content threshold, LC i is the inorganic impurity content of the i-th sample drug raw material, LC T To preset the inorganic impurity content threshold, RS i is the residual solvent content of the i-th sample pharmaceutical raw material, RS T is the preset residual solvent content threshold, Er i is the active ingredient content of the raw material of the i-th sample drug raw material, Er T Prm is the preset threshold value of the active ingredient content of the raw material. s,T is the preset quality score threshold for a single pharmaceutical raw material, n is the number of sample pharmaceutical raw materials, i≤n, and both i and n are positive integers.

[0056] According to one embodiment of the present invention, It indicates the relative difference between the preset organic impurity content threshold and the organic impurity content of the i-th sample pharmaceutical raw material. The larger the ratio is, the lower the organic impurity content of the i-th sample pharmaceutical raw material is, and the better the quality of the i-th sample pharmaceutical raw material is. It indicates the relative difference between the active ingredient content of the raw material of the i-th sample drug and the preset active ingredient content threshold of the raw material. The larger the ratio is, the higher the active ingredient content of the raw material of the i-th sample drug is, and the better the quality of the i-th sample drug raw material is. It indicates the relative difference between the preset inorganic impurity content threshold and the inorganic impurity content of the i-th sample pharmaceutical raw material. The larger the ratio is, the lower the inorganic impurity content of the i-th sample pharmaceutical raw material is, and the better the quality of the i-th sample pharmaceutical raw material is. It indicates the relative difference between the preset residual solvent content threshold and the residual solvent content of the i-th sample pharmaceutical raw material. The larger the ratio is, the lower the residual solvent content of the i-th sample pharmaceutical raw material is, and the better the quality of the i-th sample pharmaceutical raw material is. The pharmaceutical raw material quality score of the i-th sample pharmaceutical raw material is represented by the weighted sum of the organic impurity content, the active ingredient content, the inorganic impurity content and the residual solvent content of the i-th sample pharmaceutical raw material.

[0057] According to one embodiment of the present invention, in formula (1), the following two situations can be expressed in the form of conditional functions: When the condition is met, it means that the quality of the drug raw materials of the i-th sample drug raw materials does not meet the standard, and the value of the condition function is 0. When the condition is , it means that the quality of the drug raw materials of the i-th sample drug raw materials meets the standard, and the value of the conditional function is 1. It is the ratio of the number of sample pharmaceutical raw materials that meet the standards to the number of all sample pharmaceutical raw materials. The larger the ratio, the more sample pharmaceutical raw materials that meet the standards, and the higher the pharmaceutical raw material quality score of all pharmaceutical raw materials.

[0058] In this way, the quality score of pharmaceutical raw materials can be determined based on the organic impurity content, inorganic impurity content, residual solvent content and the content of active ingredients in the raw materials. During the calculation process, the quality of pharmaceutical raw materials can be judged from two aspects: the quality status of a single sample pharmaceutical raw material and the quality status of all pharmaceutical raw materials, thereby improving the comprehensiveness and accuracy of the pharmaceutical raw material quality score.

[0059] According to one embodiment of the present invention, in step S104, at multiple times in the management cycle, environmental data of the drug production area is collected by means of multiple sensors set at preset positions in the drug production area to determine the environmental data of the drug production area, wherein the environmental data includes: light data, dust concentration data, temperature data and relative humidity data.

[0060] For example, by setting up light intensity sensors, dust sensors, temperature sensors and humidity sensors at preset positions in the pharmaceutical production area (for example, where pharmaceutical raw materials are placed and stored), the lighting data, dust concentration data, temperature data and relative humidity data of the pharmaceutical production area are collected. The temperature and relative humidity of the production environment need to be controlled within an appropriate range to ensure the stability of the production process and the quality of the product. The pharmaceutical production area should avoid strong direct sunlight to reduce the impact of light on pharmaceutical raw materials and products.

[0061] According to one embodiment of the present invention, in step S105, at multiple moments in the management cycle, the operating parameters of the production equipment are determined by the production equipment monitoring system, wherein the operating parameters include: operating temperature, operating pressure, stirring power and operating flow rate.

[0062] For example, sensors and programmable logic controllers are used to monitor and control the working parameters of production equipment in real time. For equipment that requires specific temperature conditions for production (for example, dryers and reactors), the accuracy and stability of temperature control are crucial. The working temperature of the production equipment directly affects the physical properties and chemical stability of the finished drug. For production processes that require pressure control (filling and sterilization in the production of injections), the stability and accuracy of the working pressure of the production equipment are crucial to ensuring the sterility and integrity of the finished drug. The stirring power and speed of the production equipment directly affect the mixing degree and reaction rate of the reactants, which is particularly important for production processes that require uniform mixing and sufficient reaction. In the production process of liquid preparations (for example, preparation and filling of drug solutions), the control of the working flow of the production equipment directly affects the concentration, filling volume and uniformity of the finished drug. The working temperature, working pressure, stirring power and working flow of the production equipment can be monitored to indirectly judge the quality of drug production.

[0063] According to an embodiment of the present invention, in step S106, a drug production working environment score is determined based on the environmental data and the working parameters.

[0064] According to one embodiment of the present invention, step S106 includes:

[0065] Determining a real-time working environment vector according to the illumination data, the temperature data and the relative humidity data;

[0066] Determine standard illumination data, standard temperature data and standard relative humidity data according to the type of sample pharmaceutical raw materials;

[0067] Determining a standard working environment vector according to the standard illumination data, the standard temperature data and the standard relative humidity data;

[0068] Determining a real-time production equipment vector according to the working temperature, the working pressure, the stirring power and the working flow rate;

[0069] Determine the standard operating temperature, standard operating pressure, standard stirring power and standard operating flow rate according to the type of sample pharmaceutical raw materials;

[0070] Determining a standard production equipment vector according to the standard operating temperature, the standard operating pressure, the standard stirring power and the standard operating flow rate;

[0071] A pharmaceutical production working environment score is determined based on the real-time working environment vector, the standard working environment vector, the real-time production equipment vector, the standard production equipment vector and the dust concentration data.

[0072] For example, according to the illumination data, temperature data and relative humidity data, a real-time working environment vector is combined to represent the real-time environmental conditions in the drug production area; different sample drug raw materials have different requirements for illumination, temperature and relative humidity. According to the types of sample drug raw materials, standard illumination data, standard temperature data and standard relative humidity data are determined; according to the standard illumination data, standard temperature data and standard relative humidity data, a standard working environment vector is combined to represent the working environment conditions under standard conditions; according to the working temperature, working pressure, stirring power and working flow rate, a real-time production equipment vector is combined to represent the real-time working status of the production equipment; different types of sample drug raw materials have different requirements for the working temperature, working pressure, stirring power and working flow rate of the production equipment. According to the types of sample drug raw materials, the standard working temperature, standard working pressure, standard stirring power and standard working flow rate are determined; according to the standard working temperature, standard working pressure, standard stirring power and standard working flow rate, a standard production equipment vector is combined to represent the working status of the production equipment under standard conditions; according to the real-time working environment vector, the standard working environment vector, the real-time production equipment vector, the standard production equipment vector and the dust concentration data, the working environment of drug production is judged and the drug production working environment score is determined.

[0073] According to one embodiment of the present invention, determining the drug production working environment score according to the real-time working environment vector, the standard working environment vector, the real-time production equipment vector, the standard production equipment vector and the dust concentration data includes: determining the drug production working environment score Dwe according to formula (2):

[0074]

[0075] Among them, β1 and β2 are preset weights, if is a conditional function, min is a minimum value function, Ss1 is the first preset similarity, Ss2 is the second preset similarity, Wtj,k is the operating temperature of the kth production equipment at the jth moment in the management cycle, Wp j,k is the working pressure of the kth production equipment at the jth moment of the management cycle, Sp j,k is the stirring power of the kth production equipment at the jth moment of the management cycle, Wf j,k is the workload of the k-th production equipment at the j-th moment of the management cycle, is the real-time production equipment vector of the k-th production equipment at the j-th moment of the management cycle, for The transposed vector, Wt T is the standard operating temperature, Wp T is the standard working pressure, Sp T is the standard stirring power, Wf T is the standard working flow, is the standard working vector, La j is the lighting data of the pharmaceutical production area at the jth moment in the management cycle, Ta j is the temperature data of the pharmaceutical production area at the jth moment in the management cycle, Rh j is the relative humidity data of the pharmaceutical production area at the jth moment of the management cycle, is the real-time working environment vector of the pharmaceutical production area at the jth moment of the management cycle, for The transposed vector of La T is the standard illumination data, Ta T is the standard temperature data, Rh T is the standard relative humidity data, is the standard working environment vector, DC j is the dust concentration data of the pharmaceutical production area at the jth moment of the management cycle, DC T is the preset standard dust concentration threshold, m is the number of moments in the management cycle, K is the number of production equipment, j≤m, k≤K, j, m, k and K are all positive integers.

[0076] According to one embodiment of the present invention, is the cosine similarity between the real-time production equipment vector and the standard working vector of the k-th production equipment at the j-th moment of the management cycle. The larger the cosine similarity, the smaller the difference between the real-time working state and the standard working state of the k-th production equipment at the j-th moment of the management cycle. To find the average value based on the number of production equipment, it represents the average working condition of K production equipment at the jth moment of the management cycle, is the cosine similarity between the real-time working environment vector and the standard working environment vector of the drug production area at the jth moment of the management cycle. The larger the cosine similarity, the smaller the difference between the real-time environmental conditions of the drug production area at the jth moment of the management cycle and the standard environmental conditions. It indicates the relative difference between the preset standard dust concentration threshold and the dust concentration data of the drug production area at the jth moment of the management cycle. The larger the ratio, the lower the dust concentration data of the drug production area at the jth moment of the management cycle, and the better the working environment of drug production. To determine the overall pharmaceutical production environment status at the jth moment of the management cycle based on the average working conditions, real-time environmental conditions, and dust concentration conditions of K production equipment, It indicates the worst overall pharmaceutical production environment condition in the management cycle. The pharmaceutical production environment score is determined based on this, so that the pharmaceutical production environment score can reflect the worst overall pharmaceutical production environment condition in the pharmaceutical production process.

[0077] According to one embodiment of the present invention, in formula (2), the following two situations can be expressed in the form of conditional functions: When the condition is met, it means that the working state of the production equipment is in a stable state, and the value of the condition function is 1. When the condition is met, it means that the working state of the production equipment is unstable, and the value of the condition function is 0. It is the ratio between the number of moments when the working state of the k-th production equipment is relatively stable in the management cycle and the number of moments in the management cycle. The larger the ratio is, the more stable the overall working state of the k-th production equipment is in the management cycle. The average value is calculated based on the number of production equipment, indicating the overall stable working state of K production equipment. The weighted summation is performed based on the average overall working state of K production equipment and the worst overall pharmaceutical production environment condition during the management cycle to determine the pharmaceutical production environment score.

[0078] In this way, the pharmaceutical production working environment score can be determined based on the real-time working environment vector, standard working environment vector, real-time production equipment vector, standard production equipment vector and dust concentration data. During the calculation process, the pharmaceutical production working environment can be judged from two aspects: the overall pharmaceutical production environment status and the overall working stability of the production equipment, thereby improving the comprehensiveness and accuracy of the pharmaceutical production working environment score.

[0079] According to one embodiment of the present invention, in step S107, sampling is performed on the finished drug to obtain the finished drug to be tested, and the active ingredient content, microbial count and impurity content of the finished drug to be tested are determined.

[0080] According to one embodiment of the present invention, step S107 includes:

[0081] Conduct random sampling from the current batch of finished drug products to determine the sample finished drug products;

[0082] Acquiring, by an image acquisition device, images of a plurality of sample finished drug products;

[0083] Determining a packaging damage recognition result and a packaging information recognition result based on the sample finished drug image;

[0084] Screening the sample finished drugs according to the package damage identification result and the package information identification result to determine the finished drugs to be tested;

[0085] Determine the quantity ratio of the finished drug product to be tested and the finished drug product to be sampled;

[0086] Determine the active ingredient content, microbial count and impurity content of the finished drug product to be tested.

[0087] For example, based on the number of finished drugs in the current batch, the finished drugs are randomly sampled to obtain a number of sample finished drugs; the image of the sample finished drugs is collected by a camera, and the image of the sample finished drugs is recognized by an image detection model. If the packaging of the sample finished drugs in the image is damaged, the packaging damage is determined to be "damaged"; if the packaging of the sample finished drugs in the image is not damaged, the packaging damage is determined to be "not damaged"; if the identification information on the packaging of the sample finished drugs in the image (for example, approval number, product batch number, adverse reactions, contraindications, production date, shelf life and active ingredients) is complete, the packaging information recognition result is determined. If the identification information on the packaging of the sample finished drug in the image is incomplete, the packaging information recognition result is determined to be "incomplete"; the sample finished drugs with damaged packaging identified as "not damaged" and the packaging information recognition result as "complete" are screened as the finished drugs to be tested; the quantity ratio is determined according to the ratio of the number of the finished drugs to be tested to the number of the sample finished drugs, and the quantity ratio represents the qualified packaging rate of the finished drugs. The larger the quantity ratio, the higher the qualified packaging rate of the finished drugs; the chemical reaction principle is used to perform qualitative and quantitative analysis on the components in the finished drugs to be tested, and the active ingredient content, microbial quantity and impurity content of the finished drugs to be tested are determined.

[0088] According to one embodiment of the present invention, in step S108, an accelerated test is performed on the finished drug to be tested at multiple times in the test cycle, and the drug active ingredient content and degradation product content of the finished drug to be tested are obtained.

[0089] For example, accelerated experiments are conducted on finished drugs to induce them to react in a short period of time under high temperature, high humidity and strong light conditions, so as to obtain the content of active ingredients and degradation products of the finished drugs at multiple moments in the experimental cycle, and based on this, predict the stability of the finished drugs under normal storage conditions.

[0090] According to one embodiment of the present invention, in step S109, the quality score of the finished drug is determined based on the active ingredient content, the number of microorganisms, the impurity content, the drug effective ingredient content and the degradation product content.

[0091] According to one embodiment of the present invention, step S109 includes:

[0092] Fitting the active ingredient content of the drug and multiple moments in the experimental cycle to obtain a function of the active ingredient content of the drug at multiple moments in the experimental cycle;

[0093] Determining a derivative function of the active ingredient content of the drug according to the active ingredient content function of the drug;

[0094] Determine the change rate of the active ingredient content of the drug at multiple moments in the experimental cycle according to the derivative function of the active ingredient content of the drug;

[0095] Fitting the degradation product content and multiple moments in the experimental cycle to obtain a degradation product content function at multiple moments in the experimental cycle;

[0096] Determining a degradation product content derivative function according to the degradation product content function;

[0097] Determining the degradation product content change rate at multiple moments in the experimental period according to the degradation product content derivative function;

[0098] The quality score of the finished drug is determined based on the quantity ratio, the active ingredient content, the number of microorganisms, the impurity content, the drug effective ingredient content, the degradation product content, the rate of change of the drug effective ingredient content and the rate of change of the degradation product content.

[0099] For example, the content of the active ingredient of the drug and multiple moments in the experimental cycle are fitted to obtain a function of the active ingredient content of the drug that is used to describe the law that the content of the active ingredient of the drug in the experimental cycle decreases over time; the drug active ingredient content function is differentiated to determine the derivative function of the active ingredient content of the drug; the moments in the experimental cycle are substituted into the derivative function of the active ingredient content of the drug to determine the rate of change of the active ingredient content of the drug at multiple moments in the experimental cycle; the degradation product content and multiple moments in the experimental cycle are fitted to obtain a degradation product content function that is used to describe the law that the content of the degradation product in the experimental cycle increases over time; the degradation product content function is differentiated to determine the derivative function of the degradation product content; the moments in the experimental cycle are substituted into the derivative function of the degradation product content to determine the rate of change of the degradation product content at multiple moments in the experimental cycle; according to the quantity ratio, active ingredient content, microbial quantity, impurity content, drug active ingredient content, degradation product content, drug active ingredient content change rate and degradation product content change rate, the quality of the finished drug to be tested is judged to determine the quality score of the finished drug.

[0100] According to one embodiment of the present invention, the finished drug quality score is determined according to the quantity ratio, the active ingredient content, the microorganism quantity, the impurity content, the drug effective ingredient content, the degradation product content, the drug effective ingredient content change rate and the degradation product content change rate, including: determining the finished drug quality score Fpq according to formula (3),

[0101]

[0102] Among them, min is the minimum value function, t r is the rth moment of the experimental period, T e is the experimental temperature, H e is the experimental humidity, L e is the experimental light intensity, T c is the normal storage temperature, H c For normal storage humidity, L c To save the light intensity in general, AE' 1,b (t r ) is the change rate of the active ingredient content of the bth tested drug product at the rth moment of the experimental cycle, AE 1,b is the active ingredient content of the bth drug product to be tested at the initial moment of the experimental cycle, AE t DP' is the preset threshold value of the active ingredient content of the drug. 1,b (t r ) is the rate of change of the degradation product content of the bth drug product to be tested at the rth moment of the experimental cycle, DP 1,bis the degradation product content of the bth drug product to be tested at the initial moment of the experimental cycle, DR t is the preset degradation product content threshold, Qd t is the preset drug expiration date, QR is the quantity ratio of the finished drug to be tested and the finished drug of the sample, mi b is the number of microorganisms in the bth finished drug product to be tested, mi T is the preset microbial quantity threshold, im b is the impurity content of the bth drug product to be tested, im T is the preset impurity content threshold, AC b is the active ingredient content of the bth drug product to be tested, AC T is the preset threshold value of active ingredient content, B is the number of finished drugs to be tested, b≤B, and b and B are both positive integers.

[0103] According to one embodiment of the present invention, QR is the quantity ratio of the finished drug to be tested to the sample finished drug. The larger the quantity ratio is, the better the packaging quality of the current batch of finished drugs is.

[0104] According to one embodiment of the present invention, the accelerated test is usually carried out under high temperature, high humidity and strong light conditions. The decomposition rate of the drug is usually exponentially related to the temperature, humidity and light intensity. Based on this, the decomposition rate of the drug is usually exponentially related to the temperature, humidity and light intensity. Predict the change rate of active ingredient content of drugs under normal storage conditions, including: is the average rate of change of active ingredient content at multiple moments in the experimental cycle, It is the ratio of the experimental temperature to the normal storage temperature, indicating the temperature change. It is the ratio of experimental humidity to normal storage humidity, indicating the change of humidity. It is the ratio of the experimental light intensity to the conventional light intensity, indicating the change of light intensity. t The AE is the preset threshold value of the active ingredient content of the drug. When the active ingredient content of the drug product to be tested drops to the preset threshold value of the active ingredient content of the drug, it means that the drug product to be tested has expired. 1,b -AE t It indicates the decrease in the active ingredient content of the bth tested finished drug product to the failure state. represents the predicted time it takes for the bth tested drug product to become ineffective under normal storage conditions, that is, the drug shelf life predicted based on the content of the drug's active ingredient. DP is the average value calculated based on the number of finished drugs to be tested, indicating the average predicted drug expiration date determined based on the active ingredient content of B finished drugs to be tested. tThe threshold value of the degradation product content is preset. When the degradation product content of the finished drug to be tested rises to the preset degradation product content threshold value, it will cause harm to human health, indicating that the drug cannot be taken and has expired. It represents the average degradation product content change rate of the bth tested drug product during the experimental cycle, It represents the predicted change rate of the degradation product content of the bth drug under normal storage conditions, DP t -DP 1,b It indicates the increase in the degradation product content of the bth tested drug product to the failure state, represents the predicted time it takes for the bth tested drug product to become ineffective under normal storage conditions, that is, the drug shelf life predicted based on the content of degradation products, is the average value calculated based on the number of finished drugs to be tested, indicating the average predicted drug shelf life determined based on the degradation product content of B finished drugs to be tested, It means taking the minimum value of the average predicted drug shelf life determined according to the content of the active ingredient of B tested drug products and the average predicted drug shelf life determined according to the content of the degradation product of B tested drug products. The above processing of taking the minimum value can be used to determine the earliest time when the tested drug product will fail. It is the ratio of the earliest time of expiration of the finished drug to be tested to the preset drug shelf life. The larger the ratio, the better the stability of the finished drug to be tested.

[0105] According to one embodiment of the present invention, It indicates the relative difference between the preset impurity content threshold and the impurity content of the bth tested drug product. The larger the ratio is, the lower the impurity content of the bth tested drug product is, and the better the quality of the bth tested drug product is. It indicates the relative difference between the active ingredient content of the bth tested drug product and the preset active ingredient content threshold. The larger the ratio is, the more active ingredient content the bth tested drug product contains, and the better the quality of the bth tested drug product is. The relative difference between the preset microbial count threshold and the microbial count of the bth tested finished drug product. The larger the ratio, the smaller the microbial count of the bth tested finished drug product, and the better the quality of the bth tested finished drug product. represents the overall finished drug quality of the bth tested finished drug, To find the average value based on the number of tested finished pharmaceutical products, it represents the average overall finished pharmaceutical product quality of B tested finished pharmaceutical products.

[0106] According to one embodiment of the present invention, To determine the quality score of the finished drug based on the packaging quality, drug stability and overall finished drug quality.

[0107] In this way, the quality score of the finished drug can be determined based on the quantity ratio, active ingredient content, microbial count, impurity content, drug effective ingredient content, degradation product content, the rate of change of drug effective ingredient content and the rate of change of degradation product content. During the calculation process, the quality of the finished drug can be evaluated from three aspects: drug packaging quality, drug stability status and overall drug finished product quality, thereby improving the comprehensiveness and accuracy of the finished drug quality score.

[0108] According to one embodiment of the present invention, in step S110, a drug production quality management report is generated based on the drug raw material quality score, the drug production work environment score and the drug finished product quality score.

[0109] For example, when the quality score of drug raw materials is less than the set threshold, the staff is notified to inspect and manage the drug raw materials; when the drug production work environment score is less than the set threshold, the staff is notified to inspect the production equipment and production environment; when the quality score of the finished drug is less than the set threshold, the staff is notified to destroy the finished drugs that do not meet the standards.

[0110] According to the pharmaceutical production quality management method based on industrial data processing of the embodiment of the present invention, the component content of pharmaceutical raw materials and finished pharmaceutical products can be accurately analyzed, and the environmental data of the pharmaceutical production area and the working parameters of the production equipment can be collected. Further, based on the component content of the pharmaceutical raw materials, the quality of the pharmaceutical raw materials is evaluated to obtain the quality score of the pharmaceutical raw materials. Based on the environmental data of the pharmaceutical production area and the working parameters of the production equipment, the pharmaceutical production working environment is evaluated to obtain the score of the pharmaceutical production working environment. Based on the component content of the finished pharmaceutical products, the quality of the finished pharmaceutical products is evaluated to determine the quality score of the finished pharmaceutical products. The quality of pharmaceutical production can be managed in a targeted manner according to the quality score of the pharmaceutical raw materials, the score of the pharmaceutical production working environment and the quality score of the finished pharmaceutical products, thereby improving the comprehensiveness and accuracy of the management of pharmaceutical production quality. When determining the quality score of the pharmaceutical raw materials, the quality score of the pharmaceutical raw materials can be determined according to the organic impurity content, the inorganic impurity content, the residual solvent content and the active ingredient content of the raw materials. During the calculation process, the quality of the pharmaceutical raw materials can be judged from the quality status of a single sample pharmaceutical raw material and the quality status of all pharmaceutical raw materials, thereby improving the comprehensiveness and accuracy of the quality score of the pharmaceutical raw materials. When determining the score of the pharmaceutical production working environment, the score of the pharmaceutical production working environment can be determined based on the real-time working environment vector, the standard working environment vector, the real-time production equipment vector, the standard production equipment vector and the dust concentration data. During the calculation process, the pharmaceutical production working environment can be evaluated from two aspects: the overall pharmaceutical production environment status and the overall working stability of the production equipment, thereby improving the comprehensiveness and accuracy of the score of the pharmaceutical production working environment. When determining the quality score of the finished drug, the quality score of the finished drug can be determined based on the quantity ratio, active ingredient content, microbial quantity, impurity content, drug effective ingredient content, degradation product content, drug effective ingredient content change rate and degradation product content change rate. During the calculation process, the quality of the finished drug can be evaluated from three aspects: drug packaging quality, drug stability status and overall finished drug quality, thereby improving the comprehensiveness and accuracy of the finished drug quality score.

[0111] Figure 2 A block diagram of a drug production quality management system based on industrial data processing according to an embodiment of the present invention is exemplarily shown, and the system includes:

[0112] A raw material sampling module is used to sample pharmaceutical raw materials and obtain sample pharmaceutical raw materials;

[0113] The raw material detection module is used to detect impurities and active ingredients of sample drug raw materials through detection instruments to determine the organic impurity content, inorganic impurity content, residual solvent content and active ingredient content of the sample drug raw materials;

[0114] A raw material quality scoring module, used to determine the quality score of the pharmaceutical raw material according to the organic impurity content, the inorganic impurity content, the residual solvent content and the raw material active ingredient content;

[0115] An environmental data collection module is used to collect environmental data of the drug production area at multiple moments in the management cycle through multiple sensors set at preset positions in the drug production area to determine the environmental data of the drug production area, wherein the environmental data includes: light data, dust concentration data, temperature data and relative humidity data;

[0116] The production equipment monitoring module is used to determine the working parameters of the production equipment through the production equipment monitoring system at multiple moments in the management cycle, wherein the working parameters include: working temperature, working pressure, stirring power and working flow rate;

[0117] A working environment scoring module, used to determine a drug production working environment score based on the environmental data and the working parameters;

[0118] A finished product sampling module is used to sample finished drugs, obtain finished drugs to be tested, and determine the active ingredient content, microbial count, and impurity content of the finished drugs to be tested;

[0119] The accelerated test module is used to perform accelerated tests on the finished drug to be tested at multiple times during the test cycle, and obtain the content of the active ingredient and the content of the degradation product of the finished drug to be tested;

[0120] A finished product quality scoring module, used to determine the finished drug product quality score based on the active ingredient content, the number of microorganisms, the impurity content, the drug effective ingredient content and the degradation product content;

[0121] The quality management report module is used to generate a drug production quality management report based on the drug raw material quality score, the drug production work environment score and the drug finished product quality score.

[0122] The present invention may be a method, an apparatus, a system and / or a computer program product. The computer program product may include a computer-readable storage medium carrying computer-readable program instructions for executing various aspects of the present invention.

[0123] It should be understood by those skilled in the art that the embodiments of the present invention described above and shown in the accompanying drawings are only examples and do not limit the present invention. The purpose of the present invention has been fully and effectively achieved. The functional and structural principles of the present invention have been demonstrated and explained in the embodiments, and the embodiments of the present invention may be deformed or modified in any way without departing from the principles.

Claims

1. A drug production quality management method based on industrial data processing, characterized in that: include: Sampling the drug raw materials to obtain sample drug raw materials; Through testing instruments, the sample drug raw materials are tested for impurities and active ingredients to determine the organic impurity content, inorganic impurity content, residual solvent content and active ingredient content of the sample drug raw materials; Determine the quality score of the pharmaceutical raw material according to the organic impurity content, the inorganic impurity content, the residual solvent content and the active ingredient content of the raw material; At multiple moments in the management cycle, multiple sensors are arranged at preset positions in the drug production area to collect environmental data of the drug production area, and determine the environmental data of the drug production area, wherein the environmental data includes: light data, dust concentration data, temperature data and relative humidity data; At multiple moments in the management cycle, the operating parameters of the production equipment are determined through the production equipment monitoring system, wherein the operating parameters include: operating temperature, operating pressure, stirring power and operating flow rate; Determining a pharmaceutical production work environment score based on the environmental data and the work parameters; Sampling finished drugs to obtain finished drugs to be tested, and determining the active ingredient content, microbial count and impurity content of the finished drugs to be tested; At multiple times during the experimental cycle, the finished drug product to be tested is subjected to accelerated testing, and the content of the active ingredient and the content of the degradation product of the finished drug to be tested are obtained; Determine the quality score of the finished drug product based on the active ingredient content, the number of microorganisms, the impurity content, the drug effective ingredient content and the degradation product content; Generate a drug production quality management report based on the drug raw material quality score, the drug production work environment score and the drug finished product quality score; The quality score of the pharmaceutical raw material is determined based on the organic impurity content, the inorganic impurity content, the residual solvent content and the active ingredient content of the raw material, including: According to the formula Determine the drug material quality score Prm for all drug raw materials o , where if is the conditional function, α1, α2, α3 and α4 are preset weights, OC i is the organic impurity content of the i-th sample drug raw material, OC T To preset the organic impurity content threshold, LC i is the inorganic impurity content of the i-th sample drug raw material, LC T To preset the inorganic impurity content threshold, RS i is the residual solvent content of the i-th sample pharmaceutical raw material, RS T is the preset residual solvent content threshold, Er i is the active ingredient content of the raw material of the i-th sample drug raw material, Er T Prm is the preset threshold value of the active ingredient content of the raw material. s,T is the preset threshold value for the quality score of a single drug raw material, n is the number of sample drug raw materials, i≤n, i and n are both positive integers; Determine the drug production work environment score based on the environmental data and the work parameters, including: Determining a real-time working environment vector according to the illumination data, the temperature data and the relative humidity data; Determine standard illumination data, standard temperature data and standard relative humidity data according to the type of sample pharmaceutical raw materials; Determining a standard working environment vector according to the standard illumination data, the standard temperature data and the standard relative humidity data; Determining a real-time production equipment vector according to the working temperature, the working pressure, the stirring power and the working flow rate; Determine the standard operating temperature, standard operating pressure, standard stirring power and standard operating flow rate according to the type of sample pharmaceutical raw materials; Determining a standard production equipment vector according to the standard working temperature, the standard working pressure, the standard stirring power and the standard working flow rate; Determine a pharmaceutical production work environment score according to the real-time work environment vector, the standard work environment vector, the real-time production equipment vector, the standard production equipment vector and the dust concentration data; Determining a drug production work environment score according to the real-time work environment vector, the standard work environment vector, the real-time production equipment vector, the standard production equipment vector, and the dust concentration data, including: According to the formula Determine the drug production working environment score Dwe, where β1 and β2 are preset weights, if is a conditional function, min is a minimum value function, Ss1 is the first preset similarity, Ss2 is the second preset similarity, and Wt j,k is the operating temperature of the kth production equipment at the jth moment in the management cycle, Wp j,k is the working pressure of the kth production equipment at the jth moment of the management cycle, Sp j,k is the stirring power of the kth production equipment at the jth moment of the management cycle, Wf j,k is the workload of the k-th production equipment at the j-th moment of the management cycle, is the real-time production equipment vector of the k-th production equipment at the j-th moment of the management cycle, for The transposed vector, Wt T is the standard operating temperature, Wp T is the standard working pressure, Sp T is the standard stirring power, Wf T is the standard working flow, is the standard working vector, La j is the lighting data of the pharmaceutical production area at the jth moment in the management cycle, Ta j is the temperature data of the pharmaceutical production area at the jth moment in the management cycle, RH j is the relative humidity data of the pharmaceutical production area at the jth moment of the management cycle, is the real-time working environment vector of the pharmaceutical production area at the jth moment of the management cycle, for The transposed vector of La T is the standard illumination data, Ta T is the standard temperature data, RH T is the standard relative humidity data, is the standard working environment vector, DC j is the dust concentration data of the pharmaceutical production area at the jth moment of the management cycle, DC T is the preset standard dust concentration threshold, m is the number of moments in the management cycle, K is the number of production equipment, j≤m, k≤K, j, m, k and K are all positive integers; Sampling is performed in finished drug products to obtain the finished drug products to be tested, and the active ingredient content, microbial count and impurity content of the finished drug products to be tested are determined, including: Conduct random sampling from the current batch of finished drug products to determine the sample finished drug products; Acquiring, by an image acquisition device, images of a plurality of sample finished drug products; Determining a packaging damage recognition result and a packaging information recognition result based on the sample finished drug image; Screening the sample finished drugs according to the package damage identification result and the package information identification result to determine the finished drugs to be tested; Determine the quantity ratio of the finished drug product to be tested and the finished drug product to be sampled; Determine the active ingredient content, microbial count and impurity content of the finished drug product to be tested; The quality score of the finished drug product is determined based on the active ingredient content, the number of microorganisms, the impurity content, the drug active ingredient content and the degradation product content, including: Fitting the active ingredient content of the drug and multiple moments in the experimental cycle to obtain a function of the active ingredient content of the drug at multiple moments in the experimental cycle; Determining a derivative function of the active ingredient content of the drug according to the active ingredient content function of the drug; Determine the change rate of the active ingredient content of the drug at multiple moments in the experimental cycle according to the derivative function of the active ingredient content of the drug; Fitting the degradation product content and multiple moments in the experimental cycle to obtain a degradation product content function at multiple moments in the experimental cycle; Determining a degradation product content derivative function according to the degradation product content function; Determining the degradation product content change rate at multiple moments in the experimental cycle according to the degradation product content derivative function; Determine the quality score of the finished drug product based on the quantity ratio, the active ingredient content, the number of microorganisms, the impurity content, the drug effective ingredient content, the degradation product content, the rate of change of the drug effective ingredient content and the rate of change of the degradation product content; Determine the quality score of the finished drug according to the quantity ratio, the content of the active ingredient, the number of microorganisms, the impurity content, the content of the active ingredient of the drug, the content of the degradation product, the change rate of the content of the active ingredient of the drug and the change rate of the content of the degradation product, including: According to the formula Determine the finished drug quality score Fpq, where min is the minimum value function, t r is the rth moment of the experimental period, T e is the experimental temperature, H e is the experimental humidity, L e is the experimental light intensity, T c is the normal storage temperature, H c For normal storage humidity, L c To save the light intensity in general, AE' 1,b (t r ) is the change rate of the active ingredient content of the bth tested drug product at the rth moment of the experimental cycle, AE 1,b is the active ingredient content of the bth drug product to be tested at the initial moment of the experimental cycle, AE t DP' is the preset threshold value of the active ingredient content of the drug. 1,b (t r ) is the rate of change of the degradation product content of the bth drug product to be tested at the rth moment of the experimental cycle, DP 1,b is the degradation product content of the bth drug product to be tested at the initial moment of the experimental cycle, DP t is the preset degradation product content threshold, Qd t is the preset drug expiration date, QR is the quantity ratio of the finished drug to be tested and the finished drug of the sample, mi b is the number of microorganisms in the bth finished drug product to be tested, mi T is the preset microbial quantity threshold, im b is the impurity content of the bth drug product to be tested, im T is the preset impurity content threshold, AC b is the active ingredient content of the bth drug product to be tested, AC T is the preset threshold value of active ingredient content, B is the number of finished drugs to be tested, b≤B, and b and B are both positive integers.

2. A pharmaceutical production quality management system based on industrial data processing for executing the method described in claim 1, characterized in that: include: A raw material sampling module is used to sample pharmaceutical raw materials and obtain sample pharmaceutical raw materials; The raw material detection module is used to detect impurities and active ingredients of sample drug raw materials through detection instruments to determine the organic impurity content, inorganic impurity content, residual solvent content and active ingredient content of the sample drug raw materials; A raw material quality scoring module, used to determine the quality score of the pharmaceutical raw material according to the organic impurity content, the inorganic impurity content, the residual solvent content and the raw material active ingredient content; An environmental data collection module is used to collect environmental data of the drug production area at multiple moments in the management cycle through multiple sensors set at preset positions in the drug production area to determine the environmental data of the drug production area, wherein the environmental data includes: light data, dust concentration data, temperature data and relative humidity data; The production equipment monitoring module is used to determine the working parameters of the production equipment through the production equipment monitoring system at multiple moments in the management cycle, wherein the working parameters include: working temperature, working pressure, stirring power and working flow rate; A working environment scoring module, used to determine a drug production working environment score based on the environmental data and the working parameters; A finished product sampling module is used to sample finished drugs, obtain finished drugs to be tested, and determine the active ingredient content, microbial count, and impurity content of the finished drugs to be tested; The accelerated test module is used to perform accelerated tests on the finished drug to be tested at multiple times during the test cycle, and obtain the content of the active ingredient and the content of the degradation product of the finished drug to be tested; A finished product quality scoring module, used to determine the finished drug product quality score based on the active ingredient content, the number of microorganisms, the impurity content, the drug effective ingredient content and the degradation product content; The quality management report module is used to generate a drug production quality management report based on the drug raw material quality score, the drug production work environment score and the drug finished product quality score.

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