Breakout Session C Summary: Current Virus Detection Methods

References

1. 1.↵
   Ph. Eur. 2.6.16: Tests for extraneous agents in viral vaccines for human use.
2. 2.↵
   Ph. Eur. 5.2.3: Cell substrates for the production of vaccines for human use.
3. 3.↵
   FDA Guidance for Industry: Characterization and Qualification of Cell Substrates and Other Biological Materials Used in the Production of Viral Vaccines for Infectious Disease Indications (2010) http://www.fda.gov/downloads/BiologicsBloodVaccines/GuidanceComplianceRegulatoryInformation/Guidances/Vaccines/UCM202439.pdf
4. 4.↵
   ICH Q2(R1): Validation of Analytical Procedures: Text and Methodology.
5. 5.↵
   USP 1225: Validation of Compendial Methods.
6. 6.↵
   ISO 17025: Competence of Testing and Calibration Laboratories.