Preapproval inspections regulation

Until recently, CBER was the only center doing postlicensure inspections and remains the only center engaged in preapproval inspections. CBER surveillance of licensed products was described in 1998 as the inspection of manufacturing facilities for compliance with regulations, verification that product lots conform to preapproval standards and product consistency prior to their release into distribution, and evaluation of surveillance reports, such as adverse experience reports and blood fatality reports (Sensabaugh, 1998, p. 1012). 

As described in FDA s regulation, the following are the criteria to be used by FDA and the EU to access equivalence for post- and preapproval cGMP-type inspections ... 

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