1. International Consortium for Innovation and Quality in Pharmaceutical Development (IQ):
www.iqconsortium
.
2. Food and Drug Administration. Guidance for industry, PAT-a framework for innovative pharmaceutical development, manufacturing, and quality assurance. Rockville: US Department of Health and Human Services Food and Drug Administration Center for Biologics Evaluation and Research; 2004.
3. EuropeanMedicinesAgency;
http://www.ema.europa.eu/docs/en_GB/document_library/Other/2017/04/WC500225533.pdf
.
4. International conference on harmonisation of technical requirements for registration of pharmaceuticals for human use; ICH Q8R2 Pharmaceutical Development, Geneva, Switzerland, 2009.
5. International conference on harmonisation of technical requirements for registration of pharmaceuticals for human use; ICH Q9 Quality Risk Management, Geneva, Switzerland, 2005.