Manufacturer of Large Volume Parenterals A-2-44,45 Sector- 15 GIDA Industrial Area Gorakhpur-273209 (U.P.)
Manufacturer of Large Volume Parenterals
A-2-44,45 Sector- 15 GIDA Industrial Area Gorakhpur-273209 (U.P.)
Vision parenteral Pvt. Ltd
GARDEN AREA
Reception Area
OFFICE AREA
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.
CHANGE ROOM
SHOES RACK
LOCKERS
PRIMARY CHANGE ROOM
SECONDRY CHANGE ROOM
Change Room
VISITOR LOBBY
Material Receiving Area
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.
Dedusting Area
Store lobby
MATERIAL SAMPLING ROOM
SAMPLING RLAF
PASS BOX
MATERIAL UNDER TEST AREA
REJECT MATERIAL ROOM
APPROVED MATERIAL ROOM
MATERIAL DISPENSING ROOM
LABEL STORE ROOM
PACKING MATERIAL AREA
STORE LOBBY
MIXING AREA
MIXING AREAMIXING TANK
Manufacturing Facility
PRODUCTION LOBBY
Filling and Sealing Area Glass BottlesFloor, 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.
GLASS FILING MACHINE
CAPING MACHINE
Filling of P.P. BottlesFloor, 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.
FFS MACHINE
STERILIZERDouble Door Autoclaves are used for terminal sterilization of Glass & P.P. Bottles of LVP .
STERILIZER
Visual Checking and Packing Area
Visual Checking and Packing Area
Quality Control Microbiological Testing area Hot Zone area : Incubetor, Stability Chamber etc Documentations :-
Calibration record Stability records Trend analysis report SOP Microbiological monitoring
Q.C. DEPARTMENT
QUALITY CONTROL
CHEMICAL ROOM
CHEMICAL ROOM
INSTRUMENT ROOM-1
INSTRUMENT ROOM-1
INSTRUMENT ROOM-2
INSTRUMENT ROOM-3
INSTRUMENT ROOM-1
Quality Control Microbiology Room
Quality Control Sterility Room
HOT ZONE
HOT ZONE
Quality ControlBOD & INCUBATORS
Quality ControlStability chamber
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
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
Self Inspection System PersonnelPremises including personnel facilities.Maintenance of building & equipments.Storage of starting material & finished products.Equipments .Production & In -process controlsQuality control DocumentationSanitation & 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.
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.
Quality Assurance
Control Sample Sufficient quantity of control samples of raw materials and finished products are retained
for future reference
Finished Goods Finished goods placed on pallets, at controlled
Humidity &Room temperature
Boilers
Water SystemRaw Water Storage Tank
Water SystemComprises 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.
D.M. Water loop line Diagram
D.M. Water Storage Tank
Reverse Osmosis Water Plant
Water SystemMulti-column Distillation Plant
WFI Water loop line Diagram
Pure Steam Generator
WFI Storage S.S. Tanks
HVAC System Separate 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 .
AHU-system
Service Floor Separate service area is maintained for AHU’s
and for other utilities
Service Floor
D.G.SET - 370KVA
UTILITY AREAAIR COMPRSSUR
UTILITY AREAVACCUM PUMP
UTILITY AREAVAM
FIRE SYSTEM
THANK -YOU