Risk-Based Thinking in Process Validation

Agalloco, James
February 2011
Pharmaceutical Technology;Feb2011, Vol. 35 Issue 2, p68
Trade Publication
The US Food and Drug Administration's draft process-validation guidance changes regulatory expectations by requiring manufacturers to validate their processes by performing enough tests to achieve statistical significance. The author describes why statistical significance, which industry had rejected, would impose an unreasonable burden on manufacturers and provide little, if any, benefit.


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