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Modernconcept of
Pharmaceutical Factory
SterileDivision
O erations
Presenter: Md Salim Jahangir, B-Pharm( Hons), M-Pharm(DU), MBA, ISO QMS Lead Audior, Pharma!eui!al "onsulan
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STORE
RECEIVING
QUARANTINE
APPROVED MATERIAL
MATERIAL ISSUE
RECEIVING FROM
PRODUCTION
DISTRIBUTION
RECEIVING
QUARANTINE
MATERIAL ISSUE
QUARANTINEFINISHED PRODUCTRAW MATERIAL
PACKAGING
MATERIAL
STORAGE
APPROVED MATERIAL
STORAGE
RECOMMENDED AREAS OF PHARMACEUTICAL FACTORY
RECEIVING
MATERIAL ISSUE
STORAGEENGG. GOODS
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PROCESS
COMPRESSION
COATING
PACKING
PROCESS
FILLING
ENCAPSULATION!
PACKING
FILLING " SEALING
PROCESS
PACKING
FILLING " SEALING
PROCESS
PACKING
FILLING " SEALINGITOPICAL
CREAM "
OINTMENT
STEROID!
PROCESS
PACKING
PRODUCTION UNIT #
GENERAL PRODUCTS
BLISTERING
BLISTERING
TABLET
NON$ANTIBIOTIC!
CAPSULENON$ANTIBIOTIC!
DRY SYRUP
NON$ANTIBIOTIC!
TOPICAL
CREAM "
OINTMENT
NON$STEROID!
RECOMMENDED AREAS OF PHARMACEUTICAL FACTORY
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SAMPLING
TESTING STERILITY "
MICROBIAL
CONTAMINATION!
DOCUMENTATION
QUALITY ASSURANCE
PLANNING
PREPARATION
REPORTING
SAMPLING
TESTING
DOCUMENTATION
DOCUMENTATION
PRODUCT
DEVELOPMENT
Q. C
INSTRUMENTAL
" CHEMICAL! MICROBIOLOGY
RECOMMENDED AREAS OF PHARMACEUTICAL FACTORY
INSPECTION
DATA ANALYSIS
COMPLIANCEVALIDATION
QUALITY
ASSURANCE
IPQC
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POWER
STEAM
HVAC
ENGINEERING " MAINTENANCE
MACHINERY "
EQUIPMENTS
BUILDING% POWER
GENERATION "
DISTRIBUTION
WORKSHOP "
FABRICATION
MACHINE RY "
EQUIPMENTS
MAINTENANCE
WATER
GAS% FUEL "
LUBRICANT
AIR CONDITIONING
" CHILLER
MECHANICAL
ELECTRICAL
UTILITY SERVICES%
BMS% ETP "
CIVIL WORKS
RECOMMENDED AREAS OF PHARMACEUTICAL FACTORY
MACHINERY "
EQUIPMENTS
SECURITY SYSTEM
COMPUTER
NETWORKING% ERP
" COMMUNICATION
COMPUTER%
SOFTWARE "
ELECTRONICS
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HUMAN RESOURCE "
ADMINISTRATION
PRODUCTION MANAGEMENT
QUALITY MANAGEMENT
FINANCE " ACCOUNTING
FACTORY OFFICE
RECOMMENDED AREAS OF PHARMACEUTICAL FACTORY
SECURITY
DISTRIBUTION OF
FINISHED GOODS
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PHARMACEUTICAL
FORMULATION
PRODUCTS
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WASHING & DRESSING FACILITY AT EN FTRY ISMANDATORY FOR PHARMACEUTICAL FACTORY
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CLEAN DRESS IS THE PRIME COMPONENT OF PERSONNEL
PROTECTION IN PHARMACEUTICAL FACTORY
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CLEAN DRESS IS THE PRIME COMPONENT OF PERSONNEL
PROTECTION IN PHARMACEUTICAL FACTORY
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Tuesday, March 8, 201616
All rights reserved by the PresenterERSONNEL ENTRY TO RODUCTION AREA IS UNDER STRICTCONTROL SUBJECT TO CHANGE OF & WEARING OF STERILE DRESSES
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Tuesday, March 8, 2016All rights reserved by the PresenterENTRY TO RODUCTION AREA
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PERSONNEL ENTRYTHROUGH AIRLOCK
SYSTEM
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PHARMACEUTICAL FACTORY CLEANING IS THE INTEGRAL
REQUIREMENTOF &GMP
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PRODUCTION CORRIDOOR OF PHARMACEUTICAL FACTORY
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PHARMA CEUTICAL FACTORY MANUFACTURING AREA
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All rights reserved by the Presenter Tuesday, March 8, 201626PHARMACEUTICAL FACTORY HVAC SYSTEM
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All rights reserved by the PresenterREVERSE OSMOSIS WIT EDI I!"# P$RIFIED W%TER M%&$F%'T$RI&! P"
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ATER FACILITY, MULTI-COLUMN DISTILLATION LANT TO RODUCE HIGHLY URIFIED
WATER
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PURIFIED WATER '( HOURS CIRCULATING LOOP SYSTEM AT )* + C.
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Tuesday, March 8, 201634
All rights reserved by the PresenterHVAC CONTROL SYSTEM IS A PART OF BMS
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AHUs AND DEHUMIDIFIERS ARE THE INTEGRAL PART OF HVAC SYSTEM
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RAW MATERIAL ARE PROCURED FROM WORLD RENOUNED
EUROPEAN SOURCES UNDER THE LEADERSHIP
OF VERY E,PERIENCED HIGHLY QUALIFIED HEAD OF PROCUREMENT
" PLANNING
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FLOW DIAGRAM OF STORAGE FACILITY & ISSUE SYSTEM
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RAW & PACKING MATERIAL
Re&e--n/ 01 R23
M2ter-24
Q52r2nt-ne 01 R23
M2ter-24S2674-n/ 01 R23
M2ter-24
Test-n/ 01 R23 M2ter-24
89 QC De72rt6ent
Re4e2se 01 R23 M2ter-2489 QA De72rt6ent "
St0r2/e -n A77r0e
M2ter-24 Are2
Iss5e 01 R23 M2ter-24 2/2-nst D.A
A77r0e 10r6542t-0n 0rer 5ner
t;e S57er-s-0n 01 7r05&t-0n
7;2r62&-st " &;e&
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De$&2rt0n-n/ 01 B0tt4es L02-n/ 0n 0n4-neW2s;-n/ M2&;-ne
Tr5&e&t-0n WFI!
7re72re 89 654t-$&0456n-st-442t-0n 742nt &06-n/ 1r06 '(
;05rs &-r&542t-n/ 4007 s9ste6 2t
)+?C
Dr9-n/ 01 B0tt4es
2t 7re ;0t =0ne
Ster-4-=2t-0n " De$
79r0/en2t-0n En0t0@-n
1ree-n/! 01 r-e B0tt4es 2t
#+ C 2t H0t 0ne
R27- C004-n/ "
Ster-4-=2t-0n 01 B0tt4est0 '*
C 2t &004-n/ =0ne
C0nt-n505s re&0rs 01 te67er2t5re%
7ress5re% t-6e 01 e2&; =0ne 0n PLC
&0ntr044e 72ne4 3-t; 25t062t-&/r27;-&24 re&0r-n/
Filling#S$aling La$ling & Pa'ing of L)PL *o!!l$
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# A5t062t-& F-44-n/ 01 B0tt4es 3-t; LVPL s045t-0n.
# A5t062t-& St077er-n/ 01 1-44e B0tt4es 3-t; ster-4er588er 85n/s 5ner &42ss #++ LAF s5rr05n-n/ &42ss
#+++%
# C0nt-n505s 60n-t0r-n/ 01 V0456e 2r-2t-0n 2n
en-r0n6ent24 72r26eters te67 '*
C '% RH (* '
2n 2-r 7ress5re *+ 72s&24s -n 1-44-n/ 70-nt 5ner LAF
&42ss$#++! S5rr05ne 89 &42ss$#+++ 2-r 7ress5re +
72s&24s.
S72re 72rts% Dresses " r588er 85n/s 2re
ster-4-=e 2t #'#
%#*7s/ 10r '* 6-n5tes -n 2
25t062t-& 60st$;e2t ster-4-=er A5t0&42e!
C277-n/ 01 St0772r B0tt4es3-t; ster-4e 14-7 01 se24 5ner
LAF% &42ss #++ s5rr05n-n/
&42ss #+++.!
Ins7e&t-0n 01 1-44e$se24e
B0tt4es 5ner 0n4-ne
Ins7e&t-0n H00
On4-ne 428e4-n/ 01 1-44e
se24e B0tt4es 5ner
A5t0 L28e4-n/ M2&;-ne
Ster-4-=2t-0n 01 1-44e$se24e
B0tt4es -n M0-st He2t
Ster-4-=2t-0n
M2&;-neA5t0&42e! 2t #'#+C
2n #* L8 Press5re 10r +
M-n5tes.
F-n24 72&
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PROCEDURE
• The sterili!ed "#P$ s%luti%n &by 'icr%(ltrati%n) are (lled and sealed insterili!ed c%%led A'*%ules under $A+ &class100) %- +illing"ealing 'achine.
The re/uired /uantity %- A'*%ules are received. Then eart%ned theA'*%ules and $%aded %n %nline ashing 'achine. Aut%'atic Trans-erringt% ashing !%ne thr%ugh c%nvey%rs.
Aut%'atic ashing %- A'*%ules ith + *re*ared by 'ultic%lu'ndistillati%n *lant c%'ing -r%' 24 h%urs circulating l%%* syste' at 80.rying %- A'*%ules at *re h%t !%ne. "terili!ati%n ePyr%genati%n&nd%t%in -reeing) %- dried A'*%ules at 310. 9a*id %%ling %- A'*%ulesat 25 at c%%ling !%ne. Trans-erring the ashed s%rted A'*%ules insterili!ed trays.
Transfer required quantity of WFI from loop to the steam-jacketed covered washed and
sterilized processing vessel fitted with stirrer, in and outline nitrogen passing line and
transfer device !dd all weighed ingredients as per formulation sheet and order ofmi"ing Then sampled #y quality control for test release for filling
The ra 'aterials are dis*ensed acc%rding t% ra 'aterialre/uisiti%n sheet.
Then trans-er the s%luti%n -r%' *r%cessing vessel t% (lling vessel thr%ugh a*u'* (tted ith t% stage cartridge (lter &0.4 'icr%n 0.22 'icr%n).
The (lled"ealed A'*%ules are then trans-erred t% M%ist :eat
"terili!er -%r ter'inal sterili!ati%n at te'*erature 1210, 15lb;c'2 -%r 30 'inutes and then unl%ad t% c%%ling !%ne &250).
!fter $% days sterility test approved form micro#iological section,
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PROCEDURE
The sterili!ed $#P$ s%luti%n &by 'icr%(ltrati%n) are (lled and sealed &by9ubber st%**er and >i* %- seal) in sterili!ed c%%led b%ttle under $A+ &class
100) %- +illing"ealing 'achine.
The re/uired /uantity %-
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PHARMACEUTICAL FACTORY WITH EPO,Y PAINTED PASSAGES
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PHARMACEUTICAL PROCESS AREAPHARMACEUTICAL PROCESS AREA
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PHARMACEUTICAL PROCESS AREAPHARMACEUTICAL PROCESS AREA
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CLEAN ROOMS IN
PHARMA FACTORY
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Man $lo%
Maerial $lo%
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STERILITY TEST OF STERILE PRODUCT
OPHTHALMIC SOLUTION FILLING & SEALING MACHINE
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LVPL Bottle Washing Machine LVPL Bottle Sterilizing Tunnel
LVPL Bottle Entr through !e"Cartoning roo# to $ashing roo#
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A#%oule Washing Machine Sterilizing Tunnel
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Tuesday, March 8, 20165
All rights reserved by the Presenter%$TOM%TI' ("ISTER ) '%RTO&I&! M%'I&E
BLISTERING OF TABLET &CAPSULE WITH AUTOMATIC
BLISTER PACKING MACHINE
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All rights reserved by the PresenterRAINING OF HARMACEUTICAL WORK FORCE
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AB C$@"# T9ABBD D#B
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QUALITY CONTROL " QUALITY ASSURANCE
OF PHARMACEUTICAL PRODUCTS ARE
MANDATORY AS PER REGULATIONS
COMPLIANCE
DGDA %DTL% DOE
USFDA '# CFR PART '##
WHO & GMPUK MHRA
TGA AUSTRALIA
ICH% PICs GUIDELINESISO ++#: '++)
ISO #(++#
DGDA: D-re&t0r Gener24 Dr5/ A6-n-str2t-0n
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Tuesday, March 8, 2016 63All rights reserved by the Presenter
DGDA: D-re&t0r Gener24 Dr5/ A6-n-str2t-0n
DTL: Dr5/ Test-n/ L280r2t0r9.
DOE: De72rt6ent 01 En-r0n6ent 5ner M-n-str9 01 En-r0n6ent "
F0restr9 % GOB.
USFDA 21 CFR PART '## : Un-te St2tes F00 " Dr5/s A6-n-str2t-0n '#
C0e 01 Feer24 Re/542t-0ns
WHO c GMP : W0r4 He24t; Or/2n-=2t-0n $ C5rrent G00 M2n512&t5r-n/
Pr2&t-&e.
UK MHRA: Un-te K-n/06 Me-&-nes 2n He24t;&2re Pr05&tsRe/542t0r9 A/en&9.
TGA AUSTRALIA : T;er27e5t-& G00s A6-n-str2t-0n 01 A5str24-2.
ICH G5-e4-nes : Intern2t-0n24 C0n1eren&e 0n H2r60n-=2t-0n G5-e4-nes.
PICs G5-e4-nes : P;2r62&e5t-&24 Ins7e&t-0n C0nent-0n " C007er2t-0n
S&;e6e. G5-e4-nes
ISO 9001: 2008 $ Intern2t-0n24 St2n2r-=2t-0n Or/2n-=2t-0n
ISO 14001$Intern2t-0n24St2n2r-=2t-0n Or/2n-=2t-0n #(++#
En-r0n6ent!
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R54es 2n G5-2n&e
10r P;2r62&e5t-&24
M2n512&t5rers 2n
D-str-85t0rs '++
C067-4e 89 t;e Ins7e&t-0n 2n St2n2rsD--s-0n 01 t;e
Me-&-nes 2n He24t;&2re 7r05&ts
Re/542t0r9 A/en&9
London #
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CFR $ C0e 01 Feer24 Re/542t-0ns T-t4e '#
J%de %- +ederal 9egulati%nsKJTitle 21, #%lu'e 4K
J9evised as %- A*ril 1, 2013KJTL 21+9211K
&I&L' --$OOD A*D D+US
"HAP&'+ I--$OOD A*D D+U ADMI*IS&+A&IO*
D'PA+&M'*& O$ H'AL&H A*D HUMA* S'+I"'S
SUBCHAPTER C--DRUGS: GENERAL
PA+& "U++'*& OODMA*U$A"&U+I* P+A"&I"' $O+
$I*ISH'D PHA+MA"'U&I"ALS
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ISO ++#: '++) CLAUSES
CONTINUALIMPROVEMENTOFTHE InformationFlow
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MODEL OF A PROCESS BASED QUALITY MANAGEMENT SYSTEM
CUST
OMER
INPUT
I N P U
T
Product realization
PRODUCT
S
atisfac
tion
Require
ments
CONTINUAL IMPROVEMENT OF THEQUALITY MANAGEMENT SYSTEM
Managementresponsibility
Resourcemanagement
Measurement,analysis,
improvement
CUST
OMER
Information Flow
Value Adding
Activities
O
U T P
U T
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Tuesday, March 8, 2016 6All rights reserved by the Presenter
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Tuesday, March 8, 2016 71All rights reserved by the PresenterBIOAVAILIBILITY & BIO-EQUIVALENCY TESTING OF DRUGS ON HUMAN & ANIMAL
BLOOD SAM LES IS NEW A ROACH IN BANGLADESH
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Tuesday, March 8, 2016 72All rights reserved by the PresenterENVIRONMENT MONITORING OF MANUFACTURING AREA
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Tuesday, March 8, 2016 73All rights reserved by the PresenterENVIRONMENT MONITORING OF MANUFACTURING AREA ARTICLE COUNTER
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DOP TEST OF HEPA FILTERSDOP TEST OF HEPA FILTERS
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STERILITY TEST OF STERILE PRODUCT
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Non#)ial$ Par!i'l$ Co+n! , Par!i'l$Co+n!$r )ial$ Par!i'l$ Co+n!
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MICRO*IAL COLONY COUNTER FOR COUNTING OF MICRO*IAL COLONIES
GROWN ON MEDIA OF PETRIDISHES
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ENDOTO-IN TEST OF STERILE PRODUCT *Y LAL TEST METHOD
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STERILITY TEST WITH MEM*RANE FILTRATION UNIT
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All rights reserved by the Presenter Tuesday, March 8, 2016 83Accele!"e# S"!$%l%"& Te'"%() *+ P*#,c"'
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Tuesday, March 8, 2016 87All rights reserved by the PresenterATOMIC ABSOR TION S ECTRO HOTOMETER
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All rights reserved by the Presenter Tuesday, March 8, 2016 88ICRO WEIGHING WITH ELECTRONIC BALANCE
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All rights reserved by the Presenter Tuesday, March 8, 2016 8H DETERMINATION OF WATER & OTHER LIQUIDS BY H METER
EFFECTIVE PEST CONTROL IS A REGULATORY " GMP
REQUIREMENT FOR PHARMACEUTICAL FACTORY
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Tuesday, March 8, 2016 0All rights reserved by the Presenter
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2
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INS ECTION OF FINISHED SOLID RODUCTS DIS ENSING IN RETAIL
HARMACY
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