1. International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use, ICH Harmonised Tripartite Guideline, Pharmaceutical Development Q8, Step 4, 10-November-2005.
2. PQLI Key Topics - Criticality, Design Space and Control Strategy DOI 10.1007/s12247-008-9032-4.
3. International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use, ICH Harmonised Tripartite Guideline, Quality Risk Management Q9, Step 4, 9-November-2005.
4. International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use, ICH Harmonised Tripartite Guideline, Pharmaceutical Quality System Q10, Step 2, 9-May-2007.
5. Procedures for Performing a Failure Mode, Effects and Criticality Analysis, United States Military Procedure MIL-P-1629, 9-November-1949.