Regulatory Expectations of Validation/Qualification of Adventitious Virus Assays

References

1. 1.↵
   Guideline on Virus Safety Evaluation of Biotechnological Investigational Medicinal Products (EMEA/CHMP/BWP/398498/2005).
2. 2.↵
   Validation of Analytical Procedures: Text and Methodology (CPMP/ICH/381/95, ICHQ2[R1]).
3. 3.↵
   The Introduction of Nucleic Acid Amplification Technology (NAT) for the Detection of Hepatitis C Virus RNA in Plasma Pools (CPMP/BWP/390/97).
4. 4.↵
   Addendum to Note for Guidance on Plasma-Derived Medicinal Products (CPMP/BWP/269/95).
5. 5.↵
   Note for Guidance on Plasma-Derived Medicinal Products (CPMP/BWP/269/95 rev. 3).
6. 6.↵
   Chapter 2.6.21. Nucleic Acid Amplification Techniques. European Pharmacopoeia, 6th Ed.; Council of Europe: Strasbourg, 2007.
7. 7.↵
   1. Saldanha J.,
   2. Lelie N.,
   3. Heath A.

   Establishment of the first international standard for nucleic acid amplification technology (NAT) assays for HCV RNA. WHO Collaborative Study Group. Vox Sang 1999, 76 (3), 149–158.

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8. 8.↵
   1. Saldanha J.,
   2. Lelie N.,
   3. Yu M. W.,
   4. Heath A.

   ; B19 Collaborative Study Group. Establishment of the first World Health Organization International Standard for human parvovirus B19 DNA nucleic acid amplification techniques. Vox Sang 2002, 82 (1), 24–31.

   OpenUrlCrossRefPubMed
9. 9.↵
   1. Chudy M.,
   2. Hewlett I.,
   3. Saldanha J.,
   4. Bianco C.,
   5. Conrad A. J.,
   6. Gierman. T.,
   7. Heldebrant C.,
   8. Rautmann G. G.,
   9. Roth W. K.,
   10. Stramer S.,
   11. Weimer T.,
   12. Whitaker B.,
   13. Zerlauth G.

   ; NAT Task Force Group. Technical considerations for the performance of Nucleic acid Amplification Technology (NAT). Biologicals 2003, 31 (3), 153–159.

   OpenUrlCrossRefPubMed
10. 10.↵
    Note for Guidance on Virus Validation Studies: The Design, Contribution and Interpretation of Studies Validating the Inactivation and Removal of Viruses (CPMP/BWP/268/95).
11. 11.↵
    Quality of Biotechnological Products: Viral Safety Evaluation of Biotechnology Products Derived from Cell Lines of Human or Animal Origin (CPMP/ICH/295/95, ICH topic Q5A).