Parenteral Products Manufacturing Ppt (2)

8/19/2019 Parenteral Products Manufacturing Ppt (2)

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All rights reserved by the Presenter Tuesday, March 8, 20161



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Tuesday, March 8, 20162

All rights reserved by thePresenter

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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All rights reserved by the Presenter


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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!



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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


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


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


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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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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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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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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Tuesday, March 8, 2016 61All rights reserved by the Presenter

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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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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All rights reserved by the Presenter Tuesday, March 8, 2016 65

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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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 8H DETERMINATION OF WATER & OTHER LIQUIDS BY H METER

EFFECTIVE PEST CONTROL IS A REGULATORY " GMP

REQUIREMENT FOR PHARMACEUTICAL FACTORY


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2


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INS ECTION OF FINISHED SOLID RODUCTS DIS ENSING IN RETAIL

HARMACY


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Documents

Parenteral Products Manufacturing Ppt (2)