GMP Tips - Validation and Three Runs - June 27, 2006

We are often asked about process validation and whether FDA requires three consecutive successful runs or batches. Three consecutive successful runs is the “Usual and Customary” practice in industry. The only written reference from FDA we know of comes from FDA's Human Drug CGMP Notes in 1999.

You can read this reference at www.gmptrainingsystems.com/asp/resources.asp
Click on FDA Resources. (If you know of other written references from FDA, please let us know at info@GMPTrainingSystems.com and we'll pass that along in a future post.)

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