Dated: 04/09/2018

Point Raised By Inspection Team

1. Door of washing area must be permanently closed

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

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. Name Made

1. UV- Visible spectrophotometer Shimadzu, Japan
2. Hot Air oven
3. Moisture analyzer China
4. Melting point apparatus China
5. Analytical balance AND, Japan
6. pH meter China
7. Flame photometer China
8. Conductivity meter China
9. Stirrer +Heater China
10. Sanicator China
11. Dissolution test apparatus Local
12. Disintegration apparatus Local
13. Water bath Local
14. Muffle furnace China
15. Distillation unit China
16. Hardness tester China
17. Vernier Caliper China
18. screw gauge China
19. Polarimeter China
20. Friabilator Local
 List of Production Machinery

S.No. Name
1. Balance 300 kg max
2. Balance 200 kg max
3. Balance 07 kg max
4. Balance 300Gm max
5. Balance 01 kg max max
6. Horizontal mixer
7. Fluidized Bed Dryer
8. Oscillating granulator
9. Compression machine ZP-17
10. Compression machine ZP-19
11. Coating pan
12. Capsule filling machine
13. Cone mixer
14. Blister Machine (Alu-PVC)
15. Blister Machine (Alu-Alu)
16. Strip packing machine
17. Strip packing machine
18. Printer( laser jet)
19. Dehumidifier # 1
20. Dehumidifier #2
21. R.O Plant