TABLE II
Salient Features of the 2010 Guidance for Industry on Characterization and Qualification of Cell Substrates Used in Viral Vaccines
 Provides guidance to develop comprehensive testing regimens for detection of known and unknown adventitious viruses in novel vaccine cell substrates |
 As guidance, the document does not establish requirements, but provides guidance on how regulatory requirements can be addressed |
 Provides more details of many testing procedures and includes specific tests originally promulgated in 21 CFR part 630 |
 Provides updates of testing procedures |
 Includes more detail and scientific rationale for recommendations to allow manufacturers additional flexibility |
 Fosters early discussions between regulators and manufacturers regarding development of specific assays for novel cell substrates |