Fremland GLP-GMP.pptVIP

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2016-07-29 发布于江西
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Fremland GLP-GMP.ppt

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Fremland GLP-GMP.ppt

All You Never Wanted to Know AboutGLP and GMP;Research;Development;Manufacturing;What is the intent of regulations?;What is Quality?;GLP and GMP;Current Good Manufacturing Practices (GMP or cGMP);Good Laboratory Practices (GLP);Good Laboratory Practices;Part 58: Non-Clinical Laboratory Studies;Organization and Personnel;Organization and Personnel;Organization and Personnel;Organization and Personnel;Facilities;Equipment;Testing Facilities Operation;Test and Control Articles;Protocol for Conduct of a Nonclinical Laboratory Study;Records and Reports;Current Good Manufacturing Practices;Part 210: General Provisions;Part 210: General Provisions;Part 211: Finished Pharmaceuticals;Organization and Personnel;Buildings and Facilities;Buildings and Facilities;Equipment;Equipment;Control of Components and Drug Product Containers and Closures;Control of Components and Drug Product Containers and Closures;Control of Components and Drug Product Containers and Closures;Production and Process Controls;Production and Process Controls;Production and Process Controls;Packaging and Labeling Control;Packaging and Labeling Control;Holding and Distribution;Laboratory Controls;Laboratory Controls;Laboratory Controls;Laboratory Controls;Laboratory Controls;Records and Reports;Records and Reports;Records and Reports;Records and Reports;Records and Reports;Records and Reports;Records and Reports;Returned and Salvaged Drug Products;What Does It All Mean ;Important Documents;Bottom Line