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