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