As you prepare for your next FDA inspections, bear in mind some of the key focus areas, which were high priorities for FDA inspectors in the last few years—all driven by patient safety concerns, according to a top pharma executive:

  1. Poor quality investigations of customer complaints, adverse events, significant deviations and out of specification results.
  2. Failure to identify root causes of problems, or to look at other lots that might have been affected by the original issue.
  3. Processes not validated, or cleaning sufficiently validated for multi-product equipment, leading to manufacturing processes that don’t reproduce consistently and may lead to cross-contamination.
  4. Analytical methods which don’t serve their intended purpose and aren’t validated in a way consistent with ICH requirements
  5. Failure to assure data integrity in both written paper records and electronic records, particularly as it related to computer systems
  6. Failure to select appropriate supply chain
  7. Lack of vendor oversight and control, or failure to qualify vendors
  8. Neglecting to audit vendors, as well as test and sample upon receipt