The draft guidance defines key terms, such as “backup” and “audit trail,” and discusses methods for restricting unauthorized access to computer IT systems.
There’s an explanation for why “testing into compliance” is an inappropriate way to achieve desired test results, a practice that is cited increasingly in inspection reports.
A scathing letter was sent in April to Mumbai-based API producer Polidrug Laboratories, following an in-depth inspection in March 2015 (2).
FDA cited the firm for failing to record or investigate quality-related customer complaints and for production deviations and inadequate controls on computerized systems to prevent unauthorized access or changes to manufacturing data.
Today’s computerized systems require audit trails for every operation, which make discrepancies easier to detect—by both manufacturers and by FDA investigators. FDA banned all imports from this site in September 2015, as has Health Canada and other regulatory authorities (3, 4).Another warning letter to contract manufacturer Sri Krishna Pharmaceuticals highlights data integrity violations involving incomplete laboratory records, inappropriate controls on computer systems, a lack of written procedures, plus a failure to follow those procedures that are in place (5).At the same time, FDA seeks to avoid adding onerous requirements or to complicate efficient drug production.The regulators are all too aware that a hard slap on a large producer could lead to production delays that create drug shortages or reduce competition that helps maintain lower drug prices.
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There are reports of records found in trash bins, data that do not match test results, data manipulation, sample retesting to achieve desired results, and deletion of undesirable results.