1. ICH guideline Q8(R2): Pharmaceutical Development. Available at: https://www.ich.org/page/quality-guidelines. Accessed February 16, 2021.
2. ICH guideline Q9: Quality Risk Management. Available at: https://www.ich.org/page/quality-guidelines. Accessed February 16, 2021.
3. ICH guideline Q10: Pharmaceutical Quality System. Available at: https://www.ich.org/page/quality-guidelines. Accessed February 16, 2021.
4. ICH guideline Q11: Development and Manufacture af Drug Substances (Chemical Entities and Biotechnological/Biological Entities). Available at: https://www.ich.org/page/quality-guidelines. Accessed Ferbuary 16, 2021.
5. ICH guideline Q3A(R2): impurities in new drug substances. Available at: https://www.ich.org/page/quality-guidelines. Accessed February 16, 2021.