Inspection Queries.docx

Dated: 04/09/2018 Point Raised By Inspection Team 1. 2. 3. 4. 5. 6. 7. 8. 9. 10. 11. 12. 13. 14. 15. 16. 17. 18. 19. 20. 21. 22. 23. 24. 25. 26. 27. 28. 29. 30.

Door of washing area must be permanently closed Diagrammatic SOP for Sanitizer (70% IPA must be used without any smell) Provision of Corridor cleaning manager Maintaining Logbook for daily cleaning Door closer are not working properly Vacuum cleaner Standard weights for internal calibration (RMS Balances) Bulb or light should be in a proper place, so dust couldn’t accumulate on it Containers must be of SS Steel. Factory name mentioned outside on main gate Anti microbial paints in FBD area Aluminum foil should be kept in Controlled temperature and in proper packing Stability chamber for QC HPLC for QC Carl Fischer analyzer for QC RMS and Finished Goods store tem/humidity record Capsule shells should be kept in its proper place in capsule filling area Use of cone mixer for final mixing One machine for one product Fans are not allowed in production area Manufacturing in Lots are not allowed Maintaining of QC records Scopes Dispensing Area discrepancy Completion of all relevant documents (QC/Production) Hygrometers must be working properly in all sections HVAC Returns grills should be changed Bay area Raw material must be placed at least 4 inches away from wall Usage of Methylene Chloride should be stopped

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Record provision to inspection team Copy of Receipt of Technical staff documents submitted to DRAP QC equipments and Production machinery list Lay out plan List of Registered products

List of QC Instruments

S.No. 1. 2. 3. 4. 5. 6. 7. 8. 9. 10. 11. 12. 13. 14. 15. 16. 17. 18. 19. 20.

Name UV- Visible spectrophotometer Hot Air oven Moisture analyzer Melting point apparatus Analytical balance pH meter Flame photometer Conductivity meter Stirrer +Heater Sanicator Dissolution test apparatus Disintegration apparatus Water bath Muffle furnace Distillation unit Hardness tester Vernier Caliper screw gauge Polarimeter Friabilator

Made Shimadzu, Japan China China AND, Japan China China China China China Local Local Local China China China China China China Local

List of Production Machinery

S.No. 1. 2. 3. 4. 5. 6. 7. 8. 9. 10. 11. 12. 13. 14. 15. 16. 17. 18. 19. 20. 21.

Name Balance 300 kg max Balance 200 kg max Balance 07 kg max Balance 300Gm max Balance 01 kg max max Horizontal mixer Fluidized Bed Dryer Oscillating granulator Compression machine ZP-17 Compression machine ZP-19 Coating pan Capsule filling machine Cone mixer Blister Machine (Alu-PVC) Blister Machine (Alu-Alu) Strip packing machine Strip packing machine Printer( laser jet) Dehumidifier # 1 Dehumidifier #2 R.O Plant