Reminder: Two-year post approval inspections

The Coalition would like to share some important reminders with PET Drug manufacturers that may be coming up on their two-year post approval inspection. Below is a list of items FDA inspectors recently asked for in one of the current inspections. This serves as a reminder to make sure you have all of your GMP documentation and reports up to date and ready for your FDA inspection.

  1. Organizational Chart
  2. Position/job description for each personnel in the facility
  3. Bill of lading (interstate shipment document; 18O-H2O)
  4. Table of contents for all SOPs
  5. Out of specification investigations and follow-up for the past 24 months
  6. Floor layout with air specification labeled for each room
  7. SOP-LAFW qualification report (Vendor annual qualifications and reports)
  8. SOP-equipment qualification and maintenance of main instruments involved with production + analytical procedures
  9. SOP- Environmental, Personnel
  10. SOP-Personnel training and aseptic technique training records
  11. SOP-ISO 5 cleaning area
  12. SOP-Media Fill and qualification of personnel records
  13. SOP-Vendor qualification
  14. SOP-Microbiological media qualification
  15. SOP-Manufacture batch/QC records for the past 24 months
  16. SOP-Stability test
  17. SOP-Document Change records
  18. SOP- Out of Specification
  19. SOP- Manufacture and QC methods
  20. SOP- Procedure for actions taken for any sterility failures.
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