Construction of Pharmaceutical Microbial Testing Laboratory with Alignment of Data Integrity Requirements
Objective:To analyze the problems existing in the management mode of pharmaceutical microbial testing laboratories,and put forward the operation mode of pharmaceutical microbial testing laboratories to meet the requirements of data integrity.Methods:The basic management requirements of microbial laboratories in laws and regulations,testing standards,industry norms and laboratory accreditation rules,accreditation standards and related application instructions were sorted out.The multiple problems in microbial testing laboratories in China were summarized.The possible management disadvantages in the existing operation mode were tried to analyze.Results and Conclusion:Under the premise of meeting the basic requirements of laws and regulations,industry standards and accreditation,this article discusses the use of intelligent way to construct pharmaceutical microbial testing laboratories that meets data integrity requirements,and puts forward reasonable suggestions for the construction of industrial laboratory.
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