Study On 5S In Application Of The Rectification Of Defects In Drug GMP

"Good Manufacturing Practice" regulation has been enforced in China for 14 years.Although its theory has become much more mature,the situation of the operation in Chinese pharmaceutical industrial is not satisfactory.Some serious problems present in the on-site inspection of important aspects such as personnel,equipment,materials,methods,environment,etc..Examples of them include defects on material labels,lack of traceable production records and defects of field operation regulation.These defects could bring high risk to the on-site GMP management as they have a high rate of occurrence and acceptability.The weak foundation in GMP management and short-time enforcement are the external causes of the problem.In addition to this,the lack of the on-site management methods,professional personnel and the pressure of high cost are also one of the important reasons.Therefore,finding an effective management method to rationalize the management and to reduce the incidence of GMP deficiencies become a challenge for many enterprises.So this thesis started from the rectification of defects,in the aspect of personnel,equipment,materials,methods and environment which were found in daily supervision between 2013 and 2014.The current quality management status was analyzed to find out the existing problems of pharmaceutical production enterprises and their causes.After that,the application of 5S management,in which its core concept is "loyal to the scene",was used in PDCA cycle of the rectification of GMP deficiencies to help enterprises to form a set of mature defect improvement mode and establish the standardized process.These practices of rectification cultivated the way of thinking as a field worker and enhanced the management ability as well as regulated the production behavior.These actions realized the effective correction and long-term prevention of the CAPA and reduced the incidence of GMP deficiencies.