1Pharmaceutical CGMPs for the 21st Century–A Risk-Based Approach Final Report; FDA, Sep. 2004.
2Guidance for Industry; Q 10 Pharmaceutical Quality Systems Q10, FDA, Apr. 2009 ICH.
3Guide to the Inspection of Quality Systems, FDA, Aug. 1999.
4Guidance for Industry: Q9 Quality Risk Management, FDA, Jun. 2006 ICH.
5Title 21 CFR 211.25, FDA, 2015.
6Katz, P., Campbell, C.: FDA 2011 Process Validation Guidance: Process Validation Revisited. J. of GxP Compliance 16(4):18–29, 2012.
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