AUDIT AGENDA

Following information to be collected or reviewed at audit sites: 1. Collect all documents as per vendor questioner questioner is similar to last audits. 2. Site approval documents from regulatory agencies, GMP certificates etc 3. Site approvals from govt bodies like license etc 4. executed BPRs 5. Master BPRs English version 6. Process flow English version 7. Route of Synthesis English version 8. Name of chemicals using in the process English version 9. COAs of three consecutive batches 10. Stability data 11. List of QC equipments 12. List of manufacturing equipments 13. Details of dedicated block or multi purpose usage 14. Procedures for avoiding cross contamination if multi usage 15. Relevant photographs Directions for audit: 1. Open meeting Introduction Agenda 2. Site tour 3. Review of Process flow vs executed BPRs 4. Review of analytical reports 5. Review of compliance systems like change controls, OOs, market complaints, deviations SOPS vs existed records 6. Material flow Receiving testing - storage dispensing manufacturing testing FP ware house - control samples distribution 7. Documents flow issuance retrieval 8. Training records 9. Solvent dispensing, and 10. Material storage in blocks