1. U.S. FDA, Guide to Inspections validation of Cleaning Processes, 1993.
2. ICH Q7A, Good Manufacturing Practice Guide for Active Pharmaceutical Ingredients, 2000.
3. PIC/S, Guide to Good Manufacturing Practice for Medicinal Products, PE009-9, 2009.
4. PIC/S, Recommendations on validation master plan, installation and operational qualification, non-sterile process validation, cleaning validation, PI 006-2, 2004.
5. APIC, Guidance on aspects of cleaning validation in active pharmaceutical ingredient plants, 2000.