The implementation and operation of CGMP in the US pharmaceutical analysis laboratory.part2

American pharmaceutical analysis laboratory CGMP implementation and operation lecture content establishment and management of CGMP analysis laboratory CGMP laboratory SOP raw data recording and management of the establishment of standard samples, requirements and management of quality standards set and requirements of test analysis methods Procedures for generating and verifying product stability testing and implementation of analysis and calibration and management of test equipment How to deal with test results of over-standard / low-standard FDA on-site inspection and precautions of CGMP in the laboratory Introduction of FDA and questions and answers Introduction of super-efficient liquid phase analysis Chromatograph with a total of 171 pages of concept interpretation, chart explanation, case analysis

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