The document describes the facilities and operational areas of Vision Parenteral Pvt. Ltd., located in Gorakhpur, Uttar Pradesh, which manufactures large volume parenterals. It outlines various specialized areas for material handling, quality control, and sterilization processes, emphasizing the importance of contamination control and quality assurance measures in compliance with good manufacturing practices. Additionally, it details the water purification system and HVAC setup to ensure a safe and sterile manufacturing environment.

1. Manufacturer of Large Volume
Parenterals
A-2-44,45 Sector- 15 GIDA Industrial Area Gorakhpur-273209
(U.P.)

3. Vision parenteral Pvt. Ltd

4. GARDEN AREA

5. Reception Area

6. OFFICE AREA

7. The company is situated at A-2-44,45 Sector- 15 GIDA Industrial
Area Gorakhpur-273209 (U.P.)
We have a well furnished office with all
necessary facilities.

8. CHANGE ROOM

9. SHOES RACK

10. LOCKERS

11. PRIMARY CHANGE ROOM

12. SECONDRY CHANGE ROOM

13. Change Room

14. VISITOR LOBBY

15. Material Receiving Area

16. RM STORES
In RM Store we have following Segregated area:-
Dedusting Area: In this area dedusting of the received
material is done by Vacuum cleaner
Sampling Area : Sampling area has RLAF booth under
which sampling is done. The surrounding area is
supported by AHU for this booth we have different
entries for material and Men. SOP displayed.
Dispensing Area : This area is also equipped with RLAF
for dispensing the RM. Background of RLF is supported
by AHU. For this area also we have different entries per
material and men along with the equipment washing
area.

17. Dedusting Area

18. Store lobby

19. MATERIAL SAMPLING ROOM

20. SAMPLING RLAF

21. PASS BOX

22. MATERIAL UNDER TEST AREA

23. REJECT MATERIAL ROOM

24. APPROVED MATERIAL ROOM

25. MATERIAL DISPENSING ROOM

26. LABEL STORE ROOM

27. PACKING MATERIAL AREA

28. STORE LOBBY

29. MIXING AREA

30. MIXING AREA
MIXING TANK

31. Manufacturing Facility

32. PRODUCTION LOBBY

33. Filling and Sealing Area Glass Bottles
Floor, Coving and Epoxy coated. It is controlled by HEPA filter and AHU
having the cooling system. Contamination is controlled by pressure
differentiation in the area.

34. GLASS FILING MACHINE

35. CAPING MACHINE

36. Filling of P.P. Bottles
Floor, Coving and Epoxy coated. It is controlled by HEPA filter
and AHU having the cooling system. Contamination is
controlled by pressure differentiation in the area, activities
carried out under LAF.

37. FFS MACHINE

38. STERILIZER
Double Door Autoclaves are used for terminal sterilization of
Glass & P.P. Bottles of LVP .

39. STERILIZER

40. Visual Checking and Packing Area

41. Visual Checking and Packing Area

42. Quality Control
 Microbiological Testing area
 Hot Zone area : Incubetor, Stability Chamber etc
 Documentations :-
 Calibration record
 Stability records
 Trend analysis report
 SOP
 Microbiological monitoring

43. Q.C. DEPARTMENT

44. QUALITY CONTROL

45. CHEMICAL ROOM

46. CHEMICAL ROOM

47. INSTRUMENT ROOM-1

48. INSTRUMENT ROOM-1

49. INSTRUMENT ROOM-2

50. INSTRUMENT ROOM-3

51. INSTRUMENT ROOM-1

52. Quality Control
Microbiology Room

53. Quality Control
Sterility Room

54. HOT ZONE

55. HOT ZONE

56. Quality Control
BOD & INCUBATORS

57. Quality Control
Stability chamber

58. Quality Assurance
Quality assurance deptt is responsible for in process
control at all critical stages of manufacturing. QA
Department is also responsible for release of finished
batch for distribution, control of documents

59. Self Inspection System
The company has a well-defined Self-Inspection
system through which all manufacturing functions.
Engineering Department, Quality Control
Department and Warehouse are audited by a team of
representative designated by Technical Director. The
Team shall comprise of personnel from Production,
Quality Control , Quality Assurance & Engineering /
Maintenance Department. The team shall observe &
check all processes, documents during self
inspection programme

60. Self Inspection System
Personnel
Premises including personnel facilities.
Maintenance of building & equipments.
Storage of starting material & finished products.
Equipments .
Production & In -process controls
Quality control
Documentation
Sanitation & Hygiene.
Validation & revalidation programme.
Calibration of instruments or measurement system.
Recall Procedure.
Complaint Management.
Labels Controls.
Results of previous self inspection & any corrective steps taken.

61. Self Inspection System
The audit report includes the observations,
recommendations for the improvement and follow up
actions required. The audit report is submitted to the
Technical Director and major action plans are discussed.
Such inspection reports are for internal purpose and are
not shared with any other agency.

62. Quality Assurance

63. Control Sample
Sufficient quantity of control samples of raw
materials and finished products are retained
for future reference

64. Finished Goods
Finished goods placed on pallets, at controlled
Humidity &Room temperature

65. Boilers

66. Water System
Raw Water Storage Tank

67. Water System
Comprises of R.O. Plant, D.M. Water Plant and Multi-column
Distillation units. Water Purification is done by DM Water Plant,
D.M. water stored in SS tank, and WFI from Multi-column
Distillation units are separately supplied to formulation area
through UV lights in loop line system.


68. D.M. Water loop line Diagram

69. D.M. Water Storage Tank

70. Reverse Osmosis Water Plant

71. Water System
Multi-column Distillation Plant

72. WFI Water loop line Diagram

73. Pure Steam Generator

74. WFI Storage S.S. Tanks

75. HVAC SystemSeparate air handling system is provided to eliminate any
possible potential of Cross contamination from one processing
area to another. Each critical process operation has its own air
handling system, with HEPA filter temperature and humidity
control, there are 15 AHUs installed .

76. AHU-system

77. Service Floor
Separate service area is maintained for AHU’s
and for other utilities

78. Service Floor

79. D.G.SET - 370KVA

80. UTILITY AREA
AIR COMPRSSUR

81. UTILITY AREA
VACCUM PUMP

82. UTILITY AREA
VAM

83. FIRE SYSTEM

84. THANK -YOU