Risk-Based Approach for Analytical Comparability and Comparability Protocols

References

1. 1.↵
   International Conference for Harmonisation, Quality Guideline Q5E: Comparability of Biotechnological/Biological Products. ICH Geneva, 2005.
2. 2.↵
   International Conference for Harmonisation, Quality Guideline Q6B: Specifications: Test Procedures and Acceptance Criteria for Biotechnological/Biological Products. ICH Geneva, 1999.
3. 3.↵
   International Conference for Harmonisation, Quality Guideline Q5C: Stability Testing of Biotechnological/Biological Products. ICH Geneva, 1996.
4. 4.↵
   International Conference for Harmonisation, Quality Guideline Q1A(R2): Stability Testing of New Drug Substances and Products. ICH Geneva, 2003.
5. 5.↵
   International Conference for Harmonisation, Quality Guideline Q10: Pharmaceutical Quality System. ICH Geneva, 2008.
6. 6.↵
   International Conference for Harmonisation, Quality Guideline Q11: Development and Manufacture of Drug Substances (Chemical Entities and Biotechnological/Biological Entities). ICH Geneva, 2013.
7. 7.
   International Conference for Harmonisation, Quality Guideline Q9: Quality Risk Management. ICH Geneva, 2006.