Final PIC/S Data Integrity Guidance Encourages Foolproof Approaches To Drug Manufacturing Data
Association of inspectorates provides most detailed blueprint yet of how to assure pharmaceutical data integrity.
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The US FDA always encourages sponsors to ensure their suppliers and contractors are following the law, but agency inspectors may have been the only ones who could have discovered the data integrity problems that forced the downgrading of more than 100 generic drug applications.
Pharmaceutical Inspection Cooperation Scheme member inspectorates are trying out the most comprehensive manufacturing data integrity guidance yet developed. Issued amid a flurry of guidance from various authorities, it could play a key role in harmonizing regulatory approaches.
FlexBiosys wins award; others to follow. New capacity may also benefit manufacture of monoclonal antibodies and cell and gene therapies.