ICH Guidelines
Pharmacopoeias Q4B
- 2010. International Conference on Harmonization. Sterility Test General Chapter Q4B Annex 8(R1). Geneva, Switzerland.
- 2012. International Conference on Harmonization. Bacterial Endotoxins Test General Chapter Q4B Annex 14. Geneva, Switzerland.
Quality of Biotechnology Products Q5A – Q5E
- 1999. International Conference on Harmonization. Quality of Biotechnology Products: Viral Safety Evaluation of Biotechnology Products Derived From Cell Lines of Human or Animal Origin Q5A(R1). Geneva, Switzerland.
- 1995. International Conference on Harmonization. Analysis of the Expression Construct Cells Used for Production of r-DNA Derived Protein Products Q5B. Geneva, Switzerland.
- 1995. International Conference on Harmonization. Stability Testing of Biotechnological / Biological Products Q5C. Geneva, Switzerland.
- 1997. International Conference on Harmonization. Derivation and Characterization of Cell Substrates Used for Production of Biotechnological/Biological Products Q5D. Geneva, Switzerland.
- 2004. International Conference on Harmonization. Comparability of Biotechnological / Biological Products Subject to Changes in Their Manufacturing Process. Geneva, Switzerland.
Specifications Q6B
- 1999. International Conference on Harmonization. Specifications: Test Procedures and Acceptance Criteria for Biotechnological / Biological Products Q6B. Geneva, Switzerland.