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Inspection of non-US plants has identified numerous manufacturers involved with deliberate falsification of results and manipulation of data to mask failing results.
Part 210 governs CGMP for manufacturing, processing, and packaging or holding drug products.
The agency found that Sun had serious data-integrity problems and that certain physical records had been discarded.
In particular, Sun’s analysts failed to provide critical data on sampling, including information about the identification of samples tested, maintenance of a complete record of all raw data generated, test methods used, sample preparation, calculations used for analysis, signatures of persons conducting tests, dates of tests, and raw materials.
Data are valid only as long as they are complete and authentic.
Ensuring data integrity means protecting original data from accidental or intentional modification, falsification, and deletion.