Application of Control Chart in Quality Trend Analysis and Abnormal Location Management of Pharma-ceutical Production / 中国药房

OBJECTIVE:To introduce the application of control chart in quality trend analysis and abnormal location manage-ment of pharmaceutical production,thus encourage pharmaceutical manufacturing enterprises to more frequently use control chart as a statistical analysis tool in quality control process. METHODS:Taking a pharmaceutical manufacturing enterprise as examples,the way for selection of different kinds of control charts in different conditions(such as stability study,product quality review)was il-lustrated. Based on the given data of quality characteristic analysis and stability study of a certain product in this company,analysis process was demonstrated using control chart. RESULTS & CONCLUSIONS:When the sample capacity for analysis is not less than 25,meeting the minimum requirement for steady state estimation,Hugh Hart control chart (conventional control chart)alone can accurately locate the abnormal data;while under the adverse circumstance of small sample capacity,the modified control chart (such as the regression control chart)is still able to equally reflect the overall trend and out of trend(OOT)ones. As a statistical analysis tool,control chart introduced into quality management activities is an effective technic way for control.

Research on the Classification of Deviations in Drug Production / 中国药房

OBJECTIVE:To study the classification of deviation in drug production. METHODS:From the perspective of dom-inant and hidden deviation,combining with the theory of risk management,risk of deviation was evaluated with different risk man-agement tools to define the severity of the deviation,and it was handled by different methods. RESULTS & CONCLUSIONS:Ac-cording to the identifiability of deviation in actual management,the deviation was divided into dominance and hidden deviation. The dominant deviation can be divided into deep and shallow level. Whether the causes of deviation could be cleared and the conse-quences could be estimates were judged after the shallow level classification,and the deviation was further divided into simple and complex deviation. As for deviation complex,it could be evaluated with the tools of risk management to define the deviation severi-ty. As for hidden deviation,it needed beforehand preventing with the tools of risk management directly to define deviation levels and provide reference for preventive measures. In the process of deviation management,key point is to relay on the scientific meth-od to identify and classify deviation,and divide the influence levels. Combining the theory of risk management to select and use risk tools is the effective way to solve the problem.

Disucussion on the Training Mode of Medical Management Graduates Based on the Combination of School and Enterprise / 中国药房

OBJECTIVE:To explore the training method for the postgraduates majoring in medicine management,and provide reference for the teaching effect of medical management. METHODS:Based on the existing problems in the training mode of post-graduates majoring in medical management,the foundation,feasibility implementation process of the coalition of college and enter-prise were analyzed. RESULTS & CONCLUSIONS:The training mode of coalition of college and enterprise can really make teach-ers,students and enterprises to achieve a win-win situation;at the same time,through the feasibility analysis of the training mode, the performance evaluation method of multi-level evaluation system and fuzzy comprehensive evaluation are put forward to finally achieve the exploration of training management mode of undergraduates from the perspective of operational level. But in the owner-ship of intellectual property rights,technology security,personal safety of graduate and other aspects still exist some problems and need further improvement.

Application Evaluation of Hazard Analysis and Critical Control Point System in Wet Granulation and Tableting Technology / 中国药房

OBJECTIVE:To evaluate the feasibility and effectiveness of Hazard analysis and critical control point (HACCP) system in the process of production of Loratadine tablets. METHODS:Taking wet granulation and tableting technology of Lorata-dine tablets as an example,and through the introduction of the concept of HACCP,the basic theory and method of HACCP were applied for hazard analysis on each production link to find critical control points and set critical limits for production quality man-agement. RESULTS:By HACCP analysis,three links namely drying,granules fitting and mixing,internal and external packaging were finally determined as the critical control points in the process of production of Loratadine tablets,thereby critical control lim-its were set for monitoring. After effective control over the risks in the process was ensured,HACCP work plan was made and veri-fied,and the results showed that HACCP system could effectively control and reduce the risks in the process of production and en-sure quality safety. CONCLUSIONS:Application of HACCP system to wet granulation and tableting technology of Loratadine tab-lets can fully embody its feasibility and effectiveness.