CN102339415A - Risk evaluation system for medicine production and management enterprises - Google Patents
Risk evaluation system for medicine production and management enterprises Download PDFInfo
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Abstract
The invention discloses a risk evaluation system for medicine production and management enterprise; the risk evaluation assessment system comprises a data input terminal, a data processor and an assessment result display terminal. An index input terminal of the risk evaluation system can be directly and manually operated; or risk indexes of the enterprise can be input by adopting a wireless Bluetooth technology and a wireless printing terminal entering method in a one-way entering manner; the data processor processes input data according to a certain procedure to obtain risk evaluation indexes; and finally the display terminal displays an enterprise risk evaluation result. The risk evaluation system is an important decision support system for authentication and inspection, tracking inspection and flight inspection of medicines. The risk evaluation system fully integrates the intellectual resources of experts in all aspects on the basis of National Good Manufacturing Practice (GMP) by means of a modern advanced statistics technology and carries out deep excavation and analysis on first-hand data of on-site inspection and the quality regulation in the whole systematic function so that the risk evaluation system is a modern comprehensive grading early warning system which integrates the product features, enterprise brands, executive conditions of National Good Manufacturing Practice (GMP), external integrated environments, enterprise reformation and the like and is used for enterprise risk rating, risk grading evaluation and combinatory analysis.
Description
Technical field
The present invention relates to a kind of pharmaceutical production distributors risk evaluating system.
Background technology
Drug quality safety is that present stage is in highlighting the phase of drug safety problem when the severe challenge of prodrug prison systems face.In recent years; China has recurred a lot of great medicine infringement incidents, and in April, 2006, Qiqihar second pharmaceutical Co. Ltd is when the production Armillarisin A Injection; Industrial " diglycol " is used as the pharmaceutic adjuvant propylene glycol, and the result causes 13 patients dead because of the injection Armillarisin A Injection; In June, 2006 is to July; The clindamycin phosphate glucose injection that Anhui Huayuan Biological Pharmaceutical Industry Co., Ltd. produces; Do not sterilize, reduce sterilising temp, shorten sterilization time, increase sterilization cabinet charging capacity by the technological parameter of approval; Influenced sterilization effect, caused sterilization not exclusively, the result causes 11 patients dead because of injecting glad not parenteral solution; In January, 2007, Guangdong one hundred is prone to buy the blood plasma that polluted by hepatitis C virus from illegal channels, produces quiet notes human immunoglobulin(HIg), and its product is sold to 13 provinces in the whole nation, city, owing to find in time not cause large-area disastrous accident; In September, 2007; When Hualian Pharmaceutical Factory of Shanghai Pharmaceuticals Holding Co., Ltd. produces methotrexate (MTX), two kinds of injections of cytarabine hydrochloride; Not in strict accordance with GMP production management standard operation; It is not thorough to clear out a gathering place, and production line has polluted micro-vincristine sulphate, causes many areas, the whole nation to amount to serious nervous system of 130 multidigit patients and walking function infringement.
The existing supervision method of China mainly contains: day-to-day supervision inspection, follow-up investigations, flight check and authentication check.Requirement according to relevant laws and regulations: medicine GMP, GSP authentication period are 5 years; Every two years carry out at least follow-up investigations or flight check; And most of flight checks, authentication check are complained according to report or enterprise's application is carried out; Shortage can not be reacted the actual production or the business circumstance of enterprise to the active inspection of enterprise comprehensively.Set up business risk level evaluation system,, confirm the risk factor and the various index amounts of inside modules of different analysis modules according to the characteristics of evaluation object; Set up qualitative analysis pattern layer by layer, set the weighting coefficient of risk factors, the risk class of parameter and module; Finally gather the risk rating of evaluation object, and key indexs such as the probability, calculated risk incidence of poisoning incident take place in output pharmaceutical production distributors, according to the risk class and the alert status of each evaluation object; Utilize modern combination and operational research theory; Set up the Optimization Combination Analysis model, calculate the annual best enterprise accounting of each evaluation object, the enterprise high to risk index in time takes flight check, follow-up investigations; Avoid the generation of poisoning incident, guarantee the safety of medicine.
Nearly 100,000 people of pharmaceutical production and operation field practitioner, family surplus the medicine enterprise quantity 6000 produces and line of business far surpasses 100,000.The authentication check mechanism that present China continues to use is comprehensive inspection that enterprise is carried out, and is accomplished in 2-3 days by 3 overlookers.But because number of the enterprise is huge, supervision and check personnel wretched insufficiency, examination scope are difficult to cover comprehensively, through setting up business risk grading early warning system; Risks and assumptions to enterprise carries out objective, just, analysis of science, confirms excessive risk enterprise, locks high poisoning department; Guarantee homogeneity, outstanding specific aim, inspection combines with the emphasis inspection comprehensively; Reasonable disposition supervision resource reduces supervisor's labour intensity, thereby reaches the maximum effect that improves supervisory efficiency, performance supervision resource.
At present the way of U.S. FDA is based on the article that risk management method is divided CGMP inspection grade model: " limited supervision can't all cover the link of all medicines and production ... " " FDA has a responsibility for to the public effective healthy protect being provided ", mention in the literary composition that " quantity of medicine registered enterprise increases with 400% speed in 25 years in the past.The same period, CGMP inspection quantity reduces by 60%, so FDA can't accomplish the equal CGMP inspection to all registered enterprises ... ".Article has briefly introduced the notion of risk class model etc., and mentions the validity into proof risk class model, and FDA has carried out experimental analysis to enterprise, fact proved the suitably risk of evaluation of enterprises of risk model.
In June, 2006, ICH issued ICHQ9 (quality risk management), had formed three instruments of science TQC jointly with Q8 (quality comes from design), Q10 (quality management).ICH proposes the quality risk management business and government all is suitable for.
(1), the assessment of quality risk should be based upon on the scientific basic and on the influence degree to patient health;
(2), the control degree to the quality risk management should be consistent with the quality risk degree.
Provided the instrument that much carries out venture analysis among the ICHQ9:
Failure?Mode?Effects?Analysis(FMEA?&?FMECA)
Fault?Tree?Analysis(FTA)
Hazard?Analysis?and?Critical?Control?Points(HACCP)
Hazard?Operability?Analysis(HAZOP)
Preliminary?Hazard?Analysis(PHA)
We recognize that all these instruments all have its restriction, are not omnipotent, and the quality risk management will be based on the experience in past and present technical merit, its effect of competence exertion.
Some transnational pharmacy group (as: Bayer A.G) implements based on the inspection on the risk assessment basis.Office investigated to Bayer A.G in 2008, and Beyer Co., Ltd implements TAC inspection targetedly then through various countries subsidiary company is carried out risk assessment.Its risk evaluating system is the tool model just.But do not find pharmaceutical producing enterprise and distributors' risk evaluating system of a cover science.
In order to seek the effective measures that ensure drug safety, for this reason, need pharmaceutical producing enterprise and distributors' risk evaluating system of exploitation one cover science, come to ensure conscientiously drug quality and the public's drug safety of being produced.
The inventor is through moving under water research; Experienced the setting evaluation object, selected risks and assumptions, set weight, screened statistical method, set up initial model, system verification, seven stages of realization mathematical modeling; On this basis; Succeed in developing pharmaceutical producing enterprise and distributors' risk evaluating system of a cover science, accomplished the present invention.
Goal of the invention
The object of the invention just provides the pharmaceutical production distributors risk evaluating system of a cover science.
This system mainly is made up of following three parts: data input pin, data processor and assessment result display end.Like Fig. 1.
The index input end of this system can be directly manual, also can adopt wireless blue tooth technology input method, the risk indicator of input enterprise.Data processor is handled the data of input according to certain program, obtains the risk assessment index, shows the business risk assessment result through display end at last.
This system can realize following operation:
(1) classification of Data and collection
Through above analysis, the factor that produces risk in the pharmaceutical producing enterprise is summed up as following four aspects: product factors, process factors, humane factor and environmental factor.
Product factors refers to the design characteristics of product, is the intrinsic property of product.The science and product method of administration or the medication Properties of Objects that comprise the design space.
Process factors refers to influence in the enterprise production process aspects factor of product quality, comprises seven aspects of facilities and equipment, personnel, material, production, critical process, rules file and quality inspection and facilities and equipment.
Humane factor embodies management mode, theory and the values of enterprise, is the consciousness root that causes business risk, is embodied in aspects such as transition, brand, benefit, scale, sincerity and social resources are in short supply, rare factor.
Environmental factor reflection enterprise is to the contribution index of society.Comprise enterprise institution's reorganization, all previous official (referring to SFDA or BDA etc.) inspection situation, recall, bad reaction or great quality accident.
Risks and assumptions classification chart 2 shows.
The evaluation index system is the basis of business risk level evaluation system, cover the various aspects that influence business risk comprehensively.The evaluation index system specifically resolves above four types of risks and assumptions, and forms collectable data system.
At first, set up one-level, two-level index system according to the principle of classification of risks and assumptions.Find that in operational process the index system content is indeterminate, so assessment result can be different because of evaluator; Think objectifies evaluation index; At utmost the deviation brought of minimizing personnel reflects the value-at-risk of enterprise objectively, and we have set up three grades of evaluation indexes.Three grades of evaluation indexes are taken as the leading factor with GMP, are the working specifications of inspection GMP, are again the working specifications of enterprise being carried out comprehensive risk assessment.Like table 1.
Table 1: evaluation index system
Because product forms is different, its risk assessment index is also had any different, and by above index classification method, has set up the site inspection evaluation form of various formulations.
(2) processing of data
1, three grades index weight system confirms
Evaluation index according to the front is confirmed carries out weight allocation.Because each item risks and assumptions is different to the product quality influence degree, so its weight is also different.Through repeated validation repeatedly, we make three grades weight system.
The one-level weight: the weighted value that pointer is set the one-level evaluation index, the scoring of setting first class index is a centesimal system.The setting point system is a centesimal system.Product factors, process factors, environmental factor and humane factor account for 25%, 55%, 10%, 10% respectively.
The secondary weight: the weighted value that pointer is set the secondary evaluation index, the two-level index weight is divided into five grades of level Four weights according to the percentage contribution of index to product risks, and the one-level weight is decomposed.The scoring of setting two-level index is made as very value.As: environmental factor (first class index)
Three grades of weights: to three grades of evaluation indexes based on and different score value scopes that set different to the influence degree of product risks.In purified water system (two-level index), contain " deionization system " and " storage tank leakproofness " (three grades of indexs), because of its degree of risk is different, the score value scope of setting is respectively " 0-1 " divides with " 0-2 ", and weight proportion is respectively 10% and 20%.
2, the calculating of risk class assessment index
Adopt method of weighted mean as main statistical method.Its basic ideas are: take all factors into consideration the influence degree of all risk factors, and the significance level of each factor of weighted value difference is set, through making up mathematical model, extrapolate the risk class assessment index of inherent risk level then.
Concrete steps are: risks and assumptions is selected in (1), constitutes the risks and assumptions collection; (2) according to the requirement of assessment, divided rank is carried out assessment; (3) each risks and assumptions is carried out independent assessment, set up and estimate matrix; (4), confirm its corresponding flexible strategy according to each risk factors influence degree; (5) utilization weighted mean operational method calculates evaluation result; (6), confirm the risk class assessment index according to result of calculation.
f(x)＝x
1α
1+x
2α
2+Λ+x
n-1α
n-1+x
nα
n
Parameter-definition:
F (x): assessment result value x
n: n risks and assumptions valuation
N: risks and assumptions number α
n: n risks and assumptions weight
Wherein: α
1+ α
2+ α
3+ Λ+α
N-2+ α
N-1+ α
n=1
Attention:
● during the value-at-risk of the calculation risk factor, consider recency effect.When same formulation was repeatedly checked, the inspection number of times draws near, and was ascending with the associated effect of business risk value.
● when calculating the value-at-risk of enterprise, consider the weighted mean of different dosage form value-at-risk
● when analyzing the business risk value, adopt the logarithm method to strengthen the risk identification ability.Be a kind of scientific methods of mathematics manipulation data, risk difference in the time of can reflecting similar business risk close more intuitively.
3, the foundation of colour code thresholding system
In native system, the statistics through risk data draws the value-at-risk of enterprise, gives colour code and shows, can in time, observably point out the rank of its risk, for administrative intervention lays the foundation.So the Munsell system of science, sensitivity can reflect the risk situation of enterprise truely and accurately.
Through with statistics expert's demonstration, in conjunction with our understanding, adopt the ten point system rule, the colour code thresholding system below confirming based on the native system value-at-risk to enterprise's situation.
The green low-risk in value-at-risk≤3
Value-at-risk 3-5 blueness is than low-risk
The yellow potential risk of value-at-risk 5-7
The red excessive risk colour code in value-at-risk >=7
(3) demonstration of assessment result
1. the result of risk rating shows
Risk rating is the core and the basis of native system.The native system grading comprises: four modules such as blood system vaccine, sterile preparation class, ordinary preparation class, prepared slices of Chinese crude drugs class.Characteristics according to evaluation object; Confirm the risk factor and the various index amounts of inside modules of different analysis modules, set up qualitative analysis pattern layer by layer, set the weighting coefficient of risk factors; The risk class of parameter and module; Finally gather the risk rating of evaluation object, and key indexs such as the probability, calculated risk incidence of poisoning incident take place in output pharmaceutical producing enterprise, and lay the foundation for the enforcement of central interior GMP site inspection, follow-up investigations, flight check.
2. the result of combination statistics shows
Risk class and alert status according to each evaluation object; Utilize modern combination and operational research theory; Set up the Optimization Combination Analysis model, calculate the annual best enterprise accounting of each evaluation object, foundation is provided for leaders at different levels confirm supervise policy and site inspection emphasis.
(1). the integrated risk situation of evaluate drugs enterprise, distributors' risk level;
(2). assess the integrated risk situation of specific region enterprise; As: the risk situation of assessment Haidian District pharmaceutical producing enterprise.
(3). the risk situation of assessment different dosage form enterprise.As: the risk situation of assessment sterile preparation enterprise.
(4). assess the risk situation of the specific area of different enterprises.As: the risk situation of the quality inspection of evaluate drugs manufacturing enterprise.
(5). assess the risk situation of a certain risks and assumptions of different enterprises.As: the advanced degree of equipment of assessing non-sterile solid pharmaceutical preparation.
3, deep comprehensively analysis report shows
Generate various analysis and assessment reports, like pharmaceutical producing enterprise's grading report, risk rating report etc., for analysis and decision provides reference.Simultaneously, native system also provides a large amount of risk relevant informations, tentatively sets up the platform that enterprise carries out the venture analysis of GMP situation.
(1). risk assessment
(2). venture analysis
(3). risk transfer.
Native system is through periodic analysis enterprise site inspection data, like supply of material record, issuance records, inspection record, batch inspection record, bath manufacturing records etc., and the file of, operability institutional, record property in conjunction with a large amount of SMP of enterprise, SOP, BPR etc.; Analyze administration detail, production run, working specification, the quality assurance system of enterprise, find out key parameter, particularly mass parameter, technological parameter in the respective file system regulation; Again these data are carried out risk assessment; Compare with the inspection situation at scene, explore parameter drift trend, adopt red, yellow, blue, green four types of colour code early warning; Find out potential safety hazard; Take effectively to intervene administratively means in good time, make the risk of pharmaceutical production, distributors be in slave mode, guarantee the standardized operation of pharmaceutical production, process of operation.
In this system, the enterprise that different colour codes are shown takes different administrative intervention means.As: the shown in red enterprise's (being excessive risk enterprise) of colour code is locked as the emphasis supervised entities.In time carry out flight check, can transfer inspection or regain GMP, GSP certificate if find serious problems.When enterprise carries out GMP, GSP reauthentication, will extend to 4-5 days the supervision time, increase the emphasis scope of examination, carry out comprehensive inspection.
The risk class evaluating system is the important decision back-up system of medicine authentication check, follow-up investigations, flight check.This system is the basis with the standard (GMP) of national pharmaceuticals industry; Statistical technique with current advanced person is means; Fully integrate each side expert's intellectual resources; The site inspection firsthand data is goed deep into mining analysis; Among whole system function, is business risk grading, risk class assessment and the modern composite rating early warning system of combinatory analysis for one such as a product feature of melting pharmaceutical manufacturer, brand names, GMP implementation status, outside integrated environment, the restructuring of enterprise with quality monitoring.The possibility that the prediction accident takes place realizes the contingency management reach.
So far, realized mathematical modeling, and pharmaceutical producing enterprise of family surplus this city 150 has been assessed, systemic-function has been made an explanation one by one below in conjunction with assessment result.
Description of drawings
Fig. 1----risk evaluating system composition diagram.
Fig. 2----risks and assumptions figure.
The non-terminally sterilised sterile preparation risk assessment color chart of Fig. 3----.
The non-terminally sterilised sterile preparation product factors risk ranking figure of Fig. 4----.
The non-terminally sterilised sterile preparation process factors risk ranking figure of Fig. 5----.
The non-terminally sterilised sterile preparation environmental factor risk ranking figure of Fig. 6----.
The humane factor risk ordering chart of the non-terminally sterilised sterile preparation of Fig. 7----.
The non-terminally sterilised sterile preparation factory building facility risk investigation figure of Fig. 8----.
The non-terminally sterilised sterile preparation workshop risk investigation figure of Fig. 9----.
The non-terminally sterilised sterile preparation quality risk risk investigation figure of Figure 10----.
Figure 11--the personnel risk investigation figure of the terminally sterilised sterile preparation of-non-mechanism.
1. pairs of non-terminally sterilised sterile preparations of embodiment carry out risk assessment and analysis
Through the risk assessment Munsell system as can beappreciated from fig. 3, more than non-terminally sterilised sterile preparation enterprise all be in the high risk state, its risk ranking is followed successively by A-B-C-D-E-F-G.
Venture analysis: 3.1 product factors risk ranking, like Fig. 4.
Can find out among Fig. 4 that the formulation factor is all identical, to the equal proportion of the contribution of business risk, promptly the formation to business risk is not the formulation factor
3.2 the process factors risk ranking is like Fig. 5.
By finding out process factors risk ranking: B-A-C-D-E-F-G among Fig. 5.
3.3 the environmental factor risk ranking is seen Fig. 6.
By finding out environmental factor risk ranking: A-C-B-D-E-G-F among Fig. 6.
3.4 Fig. 7 is seen in humane factor risk ordering.
By finding out environmental factor risk ranking: F-A-G-B-E-C-D among Fig. 7.
| Enterprise's ordering | Business risk | Product factors | Process factors | Environmental factor | |
| A | |||||
| 1 | 1 | 2 | 1 | 2 | |
| |
2 | 1 | 1 | 3 | 4 |
| |
3 | 1 | 3 | 2 | 6 |
| |
4 | 1 | 4 | 4 | 7 |
| |
5 | 1 | 5 | 5 | 5 |
| |
6 | 1 | 6 | 7 | 1 |
| |
7 | 1 | 7 | 6 | 3 |
Go up according to this and analyze:
Can find out the weakness that these three GMP of enterprise carry out through above Fig. 8-11.
B: factory building facility, workshop, quality management, the personnel of mechanism equivalent risk are all higher
A, B, C environmental factor risk occupy first three, and customer complaint, bad reaction situation are more;
A, F, the humane factor of G occupy first three, investigate through system:
A: the performance of enterprises and business manager sincerity are the main causes that causes humane factor high
Through the statistics and analysis of native system to manufacturing enterprise's risk situation, we can carry out science, effectively administrative intervention, make the risk of pharmaceutical producing enterprise be in slave mode, keep the comparatively safe of pharmaceutical production link.
To the shown in red enterprise of colour code, promptly excessive risk enterprise differs bigger enterprise with the security risk value, is locked as the emphasis supervised entities.Can implement flight check, can transfer inspection or regain the GMP certificate as finding serious problems.The GMP of enterprise will check during reauthentication comprehensively, prolongs the supervision time, increases the scope of examination (4-5 days).
Colour code is shown as yellow enterprise, potential risk enterprise is promptly arranged, classify the follow-up investigations object as, can carry out flight check in good time, also can guide enterprise, remove a hidden danger, reduce risk.
Colour code is shown as blue enterprise,, implements conventional GMP authentication check promptly than low-risk enterprise.This type of enterprise should strengthen day-to-day supervision, prevents that it from squinting to the excessive risk direction.
To the shown in green enterprise of colour code, i.e. low-risk enterprise, in the frequency that reduces follow-up investigations, emphasis can be checked main critical item during reauthentication, shortens the supervision time (2 days).
Claims (2)
1. pharmaceutical production distributors risk evaluating system, it is made up of following three parts: data input pin, data processor and assessment result display end;
The data input pin of this system is directly manually imported the risk indicator of enterprise; Data processor can be handled the data of input according to certain program, obtains the risk assessment index, can demonstrate the business risk assessment result with diagrammatic form through the assessment result display end at last;
This system can realize following assessment operation:
(1) classification of Data and collection
The data that data input pin is imported are the factors that produce risk in the pharmaceutical production distributors, are mainly following four aspects: product factors, process factors, humane factor and environmental factor;
Product factors refers to the design characteristics of product, is the intrinsic property of product.The science and product method of administration or the medication Properties of Objects that comprise the design space;
Process factors refers to influence in the enterprise production process aspects factor of product quality, comprises seven aspects of facilities and equipment, personnel, material, production, critical process, rules file and quality inspection and facilities and equipment;
Humane factor embodies management mode, theory and the values of enterprise, is the consciousness root that causes business risk, is embodied in transition, brand, benefit, scale, sincerity and social resources factor in short supply, rare aspect;
Environmental factor reflection enterprise is to the contribution index of society.Comprise enterprise institution reorganization, all previous SFDA or BDA the inspection situation, recall, bad reaction or great quality accident;
(2) processing of data
1), three grades index weight system confirms
Evaluation index according to the front is confirmed carries out three grades of weight allocation;
The one-level weight: the weighted value that pointer is set the one-level evaluation index, the scoring of setting first class index is a centesimal system; The setting point system is a centesimal system; Product factors, process factors, environmental factor and humane factor account for 25%, 55%, 10%, 10% respectively;
The secondary weight: the weighted value that pointer is set the secondary evaluation index, the two-level index weight is divided into five grades of level Four weights according to the percentage contribution of index to product risks, and the one-level weight is decomposed; The scoring of setting two-level index is made as very value;
Three grades of weights: to three grades of evaluation indexes based on and different score value scopes that set different to the influence degree of product risks;
2), the calculating of risk class assessment index
Adopt method of weighted mean as statistical method, take all factors into consideration the influence degree of all risk factors, and the significance level of each factor of weighted value difference is set, through making up mathematical model, extrapolate the risk class assessment index of inherent risk level then;
Concrete steps are: risks and assumptions is selected in (1), constitutes the risks and assumptions collection; (2) according to the requirement of assessment, divided rank is carried out assessment; (3) each risks and assumptions is carried out independent assessment, set up and estimate matrix; (4), confirm its corresponding flexible strategy according to each risk factors influence degree; (5) utilization weighted mean operational method calculates evaluation result; (6), confirm the risk class assessment index according to result of calculation.
f(x)＝x
1α
1+x
2α
2+Λ+x
n-1α
n-1+x
nα
n
Parameter-definition:
F (x): assessment result value x
n: n risks and assumptions valuation
N: risks and assumptions number α
n: n risks and assumptions weight
Wherein: α
1+ α
2+ α
3+ Λ+α
N-2+ α
N-1+ α
n=1
3), the foundation of colour code thresholding system
In native system, the statistics through risk data draws the value-at-risk of enterprise, gives colour code and shows, can in time, observably point out the rank of its risk; Science, sensitive Munsell system can reflect the risk situation of enterprise truely and accurately;
Adopt the ten point system rule based on the native system value-at-risk, the colour code thresholding system below confirming;
The green low-risk in value-at-risk≤3
Value-at-risk 3-5 blueness is than low-risk
The yellow potential risk of value-at-risk 5-7
The red excessive risk colour code in value-at-risk >=7;
(3) demonstration of assessment result
The display end of assessment result can show following assessment result:
1). the result of risk rating
The native system grading comprises: four modules such as blood system vaccine, sterile preparation class, ordinary preparation class, prepared slices of Chinese crude drugs class; Characteristics according to evaluation object; Confirm the risk factor and the various index amounts of inside modules of different analysis modules; Set up qualitative analysis pattern layer by layer, set the weighting coefficient of risk factors, the risk class of parameter and module; Finally gather the risk rating of evaluation object, and key indexs such as the probability, calculated risk incidence of poisoning incident take place in output pharmaceutical producing enterprise;
2). the result of combination statistics
Based on the risk class and the alert status of each evaluation object, utilize modern combination and operational research theory, set up the Optimization Combination Analysis model, calculate the annual best enterprise accounting of each evaluation object;
(1). the integrated risk situation of evaluate drugs enterprise, distributors' risk level;
(2). assess the integrated risk situation of specific region enterprise;
(3). the risk situation of assessment different dosage form enterprise;
(4). assess the risk situation of the specific area of different enterprises;
(5). assess the risk situation of a certain risks and assumptions of different enterprises;
3) comprehensive deep analysis report
Generate pharmaceutical producing enterprise's grading and risk rating analysis and assessment report, native system also provides a large amount of risk relevant informations, sets up the platform that enterprise carries out the venture analysis of GMP situation;
(1). risk assessment
(2). venture analysis
(3). risk transfer.
2. based on the described pharmaceutical production of claim 1 distributors risk evaluating system, data input pin wherein replaces manually directly input with the blue tooth wireless technology input.
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| CN111951105A (en) * | 2020-08-24 | 2020-11-17 | 上海银行股份有限公司 | Intelligent credit wind control system based on multidimensional big data analysis |
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