ACHIEVING WORLD ACHIEVING WORLD STANDARDS THROUGH STANDARDS THROUGH QUALITY IN PROCESSQUALITY IN PROCESS

Presented by,Nimish Shroff (Director)M/s. Charak Pharma Pvt. Ltd.

CONTENTSINTRODUCTION

REQUIREMENTS AS PER GMP

• QUALITY MANAGEMENT SYSTEMS• PPERSONNEL• PPREMISES AND EQUIPMENT• DDOCUMENTATION• MMANUFACTURING• QQUALITY CONTROL & ASSURANCE• IINSPECTION

PREMISES AND EQUIPMENT REQUIREMENTS

• CHANGE ROOMS – PRIMARY / SECONDARY• WWAREHOUSE AREA• MMANUFACTURING AREA• QQUALITY ASSURANCE & CONTROL AREA

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REQUIREMENTS AS PER GMP

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PREMISES AND EQUIPMENT REQUIREMENTS

DESIGN

DEDICATED AREAS

SAMPLE OF FACTORY LAYOUT

personnelpackaging materialsraw/bulk materials

FIN

ISH

ED

PR

OD

UC

TS

S

TOR

AG

E A

RE

A

AP

PR

OV

ED

PM

AIR LOCK

WEIGHING

LABELING/PACKAGING

LABELING/PACKAGING

LABELING/PACKAGING

FILLING

FILLING

COMPOUNDING COMPOUNDING

LABELING/PACKAGING

COMPOUNDING/ FILLING

CLEAN EQUIPMENTSTORAGE

WASHINGAREA

QUALITY CONTROL AREA

FEMALE

MALE

FILLING

LOCKERS

LOCKERS

MICRO

BULK STORAGE

BU

LK

ST

OR

AG

E

BU

LK

ST

OR

AG

E

LAB

EL

STO

RA

GE

/C

OD

ING

AR

EA

QU

AR

AN

TIN

E

AR

EA

RE

JEC

T

AR

EA

SA

MP

LING

RM

APPROVEDRM

RE

CE

IVIN

G

Material flow through plastic door

Finished products

LAYOUT

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CHANGE ROOM IN A CONVENTIONAL HERBAL MANUFACTURING UNIT

CHANGE ROOM AS PER GMP

CHANGE ENTRY / EXIT FOR PRIMARY

CHANGE ROOM AS PER GMP

ENTRY / EXIT FOR

SECONDARY CHANGE ROOM AS PER GMP

WAREHOUSE AS PER GMP NORMS

WAREHOUSE IN A CONVENTIONAL HERBAL MANUFACTURING UNIT

RECEIVING OF RAW MATERIAL

LOADING & UNLOADING AS PER GMP

HERB’S STORE

WAREHOUSE IN A CONVENTIONAL HERBAL MANUFACTURING UNIT

SUGAR STORE

WAREHOUSE IN A CONVENTIONAL HERBAL MANUFACTURING UNIT

UNDER TEST AREA REJECTED AREA

WAREHOUSE IN A CONVENTIONAL HERBAL MANUFACTURING UNIT

RECEIVING BAY RM & PM

RECEIPT OF

RAW & PACKING MATERIAL AS PER GMP

MATERIAL ENTRY

SAMPLING AREA

MAN ENTRY

SAMPLING AREA AS PER GMP

CLEANED SAMPLING DEVICES

SAMPLING OF RAW MATERIALS AS PER GMP

SAMPLING BOOTH

STORGE OF RAW MATERIALS AS PER GMP

A.C. STORAGE AREA AS PER GMP

QUARANTINE & REJECTED AREAS AS PER GMP

WEIGHING & DISPENSING

DISPENSING OF RAW MATERIALS IN A CONVENTIONAL HERBAL MANUFACTURING UNIT

WEIGHING & DISPENSING AS PER GMP

STORAGE OF PRIMARY PACKING MATERIALS IN A CONVENTIONAL HERBAL MANUFACTURING UNIT

STORAGE OF PRINTED PACKING MATERIAL AS PER GMP

A.C. STORAGE OF PRIMARY PACKING MATERIAL AS PER GMP

MANUFACTURING & PACKING AREAS

FLOORS

CONSTRUCTION AS PER GMP

WALLS & CEILINGS AS PER GMP

FLOOR

CEILING WITHOUT JOINT

CEILING WITH JOINT

WALLS & CEILINGS AS PER GMP

THE JOINTS OF ALL SURFACES

THE DESIGNS OF WINDOWS AND THE WAY THEY FIT INTO THE FRAMES

JOINTS & FRAMES AS PER GMP

X

VENTILATION AS PER GMP

’

MANUFACTURING AREA AS PER GMP

DISTILLATION ASSEMBLY

EQUIPMENTS IN A CONVENTIONAL HERBAL MANUFACTURING UNIT

LIQUID MANUFACTURING TANKS

EQUIPMENTS IN A CONVENTIONAL HERBAL MANUFACTURING UNIT

MANUFACTURING TANK

EQUIPMENTS IN A CONVENTIONAL HERBAL MANUFACTURING UNIT

TANK WITH STIRRER

EQUIPMENTS IN A CONVENTIONAL HERBAL MANUFACTURING UNIT

EQUIPMENTS IN LIQUID MANUFACTURING AREA AS PER GMP

LIQUID MANUFACTURING VESSELS

EQUIPMENTS IN LIQUID MANUFACTURING AREA AS PER GMP

MULTIMILL

HYDRAULIC LIFTER

SIFTER

DOUBLE E CONBLENDER

EQUIPMENTS IN CAPSULE MANUFACTURING AREA AS PER GMP

CAPSULE FILLING MACHINE

EQUIPMENTS IN CAPSULE MANUFACTURING AREA AS PER GMP

RAPID MIXER GRANULATOR

EQUIPMENTS IN TABLET MANUFACTURING AREA AS PER GMP

FLUIDISED BED DRYER

FBD BOWL TRANSFER TO CONTA BIN

EQUIPMENTS IN TABLET MANUFACTURING AREA AS PER GMP

BLENDER WITH CONTA BIN

EQUIPMENTS IN TABLET MANUFACTURING AREA AS PER GMP

EQUIPMENTS IN TABLET MANUFACTURING AREA AS PER GMP

NEOCOTA – TABLET COATING SYSTEM

EQUIPMENTS IN TABLET MANUFACTURING AREA AS PER GMP

PACKAGING AREA IN A CONVENTIONAL HERBAL MANUFACTURING UNIT

PACKAGING AREA IN A CONVENTIONAL HERBAL MANUFACTURING UNIT

PACKAGING AREA AS PER GMP

BOTTLE WASHING MACHINE

EQUIPMENTS IN LIQUID MANUFACTURING AREA AS PER GMP

BOTTLE FILLING & SEALING MACHINE

EQUIPMENTS IN LIQUID MANUFACTURING AREA AS PER GMP

VISUAL INSPECTION

EQUIPMENTS IN LIQUID MANUFACTURING AREA AS PER GMP

BLISTER PACKING MACHINE

EQUIPMENTS IN CAPSULE MANUFACTURING AREA AS PER GMP

VISUAL INSPECTION AT CONVEYER BELT

EQUIPMENTS IN CAPSULE MANUFACTURING AREA AS PER GMP

QUALITY ASSURANCE &

CONTROL AREAREFERENCE STANDARD

RECORD CUPBOARDREAGENT & SOLVENT

LABORATORY APPARATUS

CONCLUSION

Thank You !