Design And Implementation Of The Validation Scheme Of Cold Storage In Pharmaceutiacal Wholesale Enterprises

The safety and effectiveness of the drug will be affected by the temperature exceeding the standard in the storage and transportation of coldmedicines.The impact is cumulative and irreversibl.The cold storage in pharmaceutical wholesale enterprises is the key equipment to ensure the quality and safety of cold medicinesin the storage process.It needs to be verified before storage to meet therequirements.The research is carried out to meet the requirements of the "Good Supply Practices" and the cold storage.The new cold storage in pharmaceutical wholesale enterprises are verified to confirm whether the cold storage can meet the requirements of being put into use.Chapter 1 introduces the research background,significance and content.The design of the cold storage verification scheme is carried out in Chapter 2.According to the requirements of laws and regulations and the actual use requirements of cold storage,the personnel,object,purpose,project,principle of temperature recorder layout and implementation process of verification should be clearly defined,and the corresponding data statistical table was designed.Finally,a complete set of verification scheme was designed.The verification and implementation of the cold storagehas been carried out in Chapter 3.Within six days,according to the process of verification scheme design,the confirmation of facilities and equipment of the cold storage,the layout of temperature recorder and the specific implementation of the verification project were carried out respectively.The analysis of the verification data of the refrigerator has been completed in Chapter 4.Through the statistical analysis of the temperature distribution characteristics test,open door operation test,thermal insulation performance test,performance test of the standby refrigeration unit and the temperature data obtained from the test point terminal,the verification conclusion is drawn.The full text summary and the prospect have been set forth in Chapter 5.In this thesis,according to the verification scheme,the verification implementation of the refrigerated warehouse is completed.And the results showed that the facilities and equipment of the refrigerated warehouse could meet the requirements of cold medicines,which meets the requirements of being put into use.The verification work provides a guarantee for the quality and safety of refrigerated drug storage.