品研究实验原始记审核技术要求.ppt

案例分析 (4) what is the deficiency of this GLP tox study audited vs regulations? SD 试验报告 Is data acceptable for supporting safety evaluation? NO！！ 案例分析 (5) Findings of inspection at JKL labs Study incomplete when safety summary written recovery group not yet sacrificed histopathologic findings not available memo used to prepare the integrated safety summary not maintained 案例分析 (5) Q: what is the deficiency of this GLP study audited vs regulations? Is data acceptable for supporting safety evaluation? 案例分析 (5) what is the deficiency of this GLP tox study audited vs regulations? 数据完整性 Is data