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.