From a regulatory perspective,drug quality consistency evaluation must concern different processes used for the same drug.In this study,an assessment strategy based on quality by design(QbD)was developed for populatio...From a regulatory perspective,drug quality consistency evaluation must concern different processes used for the same drug.In this study,an assessment strategy based on quality by design(QbD)was developed for population pharmaceutical quality evaluation.A descriptive analysis method based on QbD concept was first established to characterize the process by critical evaluation attributes(CEAs).Then quantitative analysis method based on an improved statistical process control(SPC)method was established to investigate the process indicators(PIs)in the process population,such as mean distribution,batch-to-batch difference and abnormal quality probability.After that rules for risk assessment were established based on the SPC limitations and parameters.Both the SPC parameters of the CEAs and the risk of PIs were visualized according to the interaction test results to obtain a better understanding of the population pharmaceutical quality.Finally,an assessment strategy was built and applied to generic drug consistency assessment,process risk assessment and quality trend tracking.The strategy demonstrated in this study could help reveal quality consistency from the perspective of process control and process risk,and further show the recent development status of domestic pharmaceutical production processes.In addition,a process risk assessment and population quality trend tracking provide databased information for approval.Not only can this information serve as a further basis for decisionmaking by the regulatory authority regarding early warnings,but it can also reduce some avoidable adverse reactions.With continuous addition of data,dynamic population pharmaceutical quality is meaningful for emergencies and decision-making regarding drug regulation.展开更多
Achieving Six-Sigma process capability starts with l istening to the Voice of the Customers, and it becomes a reality by combining th e People Power and the Process Power of the organisation. This paper presents a Six...Achieving Six-Sigma process capability starts with l istening to the Voice of the Customers, and it becomes a reality by combining th e People Power and the Process Power of the organisation. This paper presents a Six-Sigma implementation case study carried out in a magnet manufacturing compa ny, which produces bearing magnets to be used in energy meters. If the thickness of the produced bearing magnets is between 2.35 mm and 2.50 mm, they will be ac cepted by the customers. All the time the company could not produce the bearing magnets within the specified thickness range, as their process distribution was flat with 2.20 mm as lower control limit and 2.60 mm as upper control limit. This resulted in a huge loss in the form of non-conformities, loss of time and goodwill. The process capability of the company then was around 0.40. Organisat ion restructuring was carried out to reap the benefit of the People Power of the organisation. Statistically designed experiments (Taguchi Method based Design o f Experiments), Online quality control tools (Statistical Process Control To ols) were effectively used to complete the DMAIC (Define, Measure, Analyse, Impr ove and Control) cycle to reap the benefit of the Process Power of the organisat ion. Presently the company enjoys a process capability of 1.75, a way towards Si x-Sigma Process Capability.展开更多
The method of designing industrial processes of quench cooling, in particular, the speed of the conveyor movement with regard to shape and sizes of parts to be quenched, thermal and physical properties of material and...The method of designing industrial processes of quench cooling, in particular, the speed of the conveyor movement with regard to shape and sizes of parts to be quenched, thermal and physical properties of material and cooling capacity of quenchants has been developed. The suggested designing method and databases are the basis for the complete automation of industrial processes of quench cooling, especially for continuous conveyor lines, with the purpose of making high-strength materials. The process is controlled by infrared technique.展开更多
基金The National Major Scientific and Technological Special Project for‘Significant New Drugs Development’(Grant No.:2017ZX0901001-007)provides support for this study.
文摘From a regulatory perspective,drug quality consistency evaluation must concern different processes used for the same drug.In this study,an assessment strategy based on quality by design(QbD)was developed for population pharmaceutical quality evaluation.A descriptive analysis method based on QbD concept was first established to characterize the process by critical evaluation attributes(CEAs).Then quantitative analysis method based on an improved statistical process control(SPC)method was established to investigate the process indicators(PIs)in the process population,such as mean distribution,batch-to-batch difference and abnormal quality probability.After that rules for risk assessment were established based on the SPC limitations and parameters.Both the SPC parameters of the CEAs and the risk of PIs were visualized according to the interaction test results to obtain a better understanding of the population pharmaceutical quality.Finally,an assessment strategy was built and applied to generic drug consistency assessment,process risk assessment and quality trend tracking.The strategy demonstrated in this study could help reveal quality consistency from the perspective of process control and process risk,and further show the recent development status of domestic pharmaceutical production processes.In addition,a process risk assessment and population quality trend tracking provide databased information for approval.Not only can this information serve as a further basis for decisionmaking by the regulatory authority regarding early warnings,but it can also reduce some avoidable adverse reactions.With continuous addition of data,dynamic population pharmaceutical quality is meaningful for emergencies and decision-making regarding drug regulation.
文摘Achieving Six-Sigma process capability starts with l istening to the Voice of the Customers, and it becomes a reality by combining th e People Power and the Process Power of the organisation. This paper presents a Six-Sigma implementation case study carried out in a magnet manufacturing compa ny, which produces bearing magnets to be used in energy meters. If the thickness of the produced bearing magnets is between 2.35 mm and 2.50 mm, they will be ac cepted by the customers. All the time the company could not produce the bearing magnets within the specified thickness range, as their process distribution was flat with 2.20 mm as lower control limit and 2.60 mm as upper control limit. This resulted in a huge loss in the form of non-conformities, loss of time and goodwill. The process capability of the company then was around 0.40. Organisat ion restructuring was carried out to reap the benefit of the People Power of the organisation. Statistically designed experiments (Taguchi Method based Design o f Experiments), Online quality control tools (Statistical Process Control To ols) were effectively used to complete the DMAIC (Define, Measure, Analyse, Impr ove and Control) cycle to reap the benefit of the Process Power of the organisat ion. Presently the company enjoys a process capability of 1.75, a way towards Si x-Sigma Process Capability.
文摘The method of designing industrial processes of quench cooling, in particular, the speed of the conveyor movement with regard to shape and sizes of parts to be quenched, thermal and physical properties of material and cooling capacity of quenchants has been developed. The suggested designing method and databases are the basis for the complete automation of industrial processes of quench cooling, especially for continuous conveyor lines, with the purpose of making high-strength materials. The process is controlled by infrared technique.
