We just had a very successful site visit to CBI by the FDA! They spent a week with us and we had NO GLP findings!

One area that the FDA appears to be interested in and apparently will be becoming more interested in, is test article manufacturing. Specifically, that preclinical CROs treat test article manufacturing as a MultiSite Site as per the OECD! This is a new concept for the CRO industry and it appears highly impractible that the QAU of a CRO would be expected to audit the sponsor’s manufacturing site to assure that the test article manufacture meets all GLP requirements. Traditionally, in our industry a Certificate of Analysis or similar document has been acceptable to assure that the TA supplied by the Sponsor meets GLP requirements. This needs to be nipped in the bud!