Methods To carry out specific discussions and analysis focusing on FDA inspection on GMP conformance for the manufacturing of active pharmaceutical ingredients (APIs).
方法针对FDA关于原料药gmp现场检查的重点进行详细论述和分析。
A routine FDA inspection of the practices of the physician who enrolled the most patients - more than 400 - uncovered fraud, including complete fabrication of patient enrollment.
在一次FDA对招募受试者最多(超过400名)的医生的例行检查中发现了医生的造假行为,包括伪造患者的入组。
A routine FDA inspection of the practices of the physician who enrolled the most patients - more than 400 - uncoered fraud, including complete fabrication of patient enrollment.
FDA对登记病人最多的医生进行常规的调查,该医生登记了400多个患者,包括假患者以及构造假的病人登记表。
Results and Conclusion If enterprises have set up effective GMP system, an approval form FDA inspection would be safely assured.
结果与结论企业如果建立了有效的GMP制度,那么企业完全能够通过FDA的认证。