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1

c;npTkfbgcEof;-hL=Pd=kL=_

sf;fwf/0fcawf/gfx?

/o;sf]dxTj

c;npTkfbgcEof;-hL=Pd=kL=_

sf;fwf/0fcawf/gfx?

/o;sf]dxTjhoaL/sdf{rfo{la/u+h,g]kfn

02.10.2010 GPANGMPQSTNEP JBK 1001

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02.10.2010 GPANGMPQSTNEP JBK 1001 2

p4]Zox? (Objectives)

hLPdkLsf cfaZostfx? Aff/]df hfu?ktf Nofpg](Develop awareness on GMP requirements)

hLPdkLsf] k|efasf/L sfo{Gjogdfck]6/x?nfO{ pT;flxt ug]{(Motivate operators for effective implementation of GMP)

hLPdkLsf] k|efasf/L sfo{Gjogu/Lu'0f:t/Lo cf}iflw pTkfbg Ifdtfclea[lw ug]{(Improve capability for manufacturing quality medicine witheffective implementation of GMP)

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u'0f:t/af/] rlr{t kl/efiffx?

cfa:ostf cg'?k ePsf]"conformance to requirements"(Crosby)ahf/sf] dfu adf]lhdsf] ul/Psf] k|efasf/L

pTkfbg efficient production of the quality that the market expects"(Deming)

Kf|of]usf]nflu ldn]sf]M a:t' sfdsf] / v/faLgePsf] "fitness for use"; "product performance and freedom fromdeficiencies" (Juran)

;dfhnfO{ xfgL gug]{"does not impart loss to society"(Taguchi)

cfaZostf cg'?ksf ;du| rl/q ePsf a:t' jf ;]jf"thetotality of features and characteristics of a product or service that bear on its

ability to satisfy a given need" (American Society for Quality Control)

u'0f:t/ (Quality):

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u'0f:t/Lo cf}iflwsf rl/qx?(Characteristics of a drug quality)

;lx ;ls|o tTj ePsf](Identity): correct active ingredient is present xfgLsf/s kbfy{ /lxt ;'4 ePsf] (Purity): not

contaminated with potentially harmful substance.

cfaZos dfqfsf] ;ls|o tTj ePsf] (Potency): correctamount of active ingredient is present (95-110%)

cfaZos u'0fx?df ;dfgtf ePsf] (Uniformity): novariation in consistency, colour, shape and size of dosage form Zfl//leq cfaZos sfd ug]{ u'0f ePsf]

(Bioavailability): consistent to provide predictable therapeutic result

Dofb eP;Dd sfd ug]{ u'0f ePsf] (Stability):ensured expected activity until stated expiry

kmdf{sf]lkof cg'?ksf] :tl/otf ePsf](Pharmacopoeial Standard): meets standards described in a widely acceptedpharmacopoeia

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u'0f:t/ k|Tofe"t [Quality Assurance (QA)]

c;n pTkfbg cEof;[Good Manufacturing Practices (GMP)]

u'0f:t/ lgoGq0f[Quality Control (QC)]

u'0f:t/ Aoa:yfkg [Quality Management (QM)]

The concepts of QA, GMP and QC are interrelatedaspects of Quality Management

u'0f:t/ ;DaGwx? (Quality Relationships)

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c;n pTkfbg cEof; -lhPdkL_ u'0f:t/k|Tofe"ltsf] Tof] c+z xf] h;n] k|of]u ;'xf+pbf] -u'0f:tl/o, c;/o"St,

hg;'/lIft_ / cf}iflw Joj:yf ljefun]tf]s]sf] cfaZostf k'/f ePsf] u'0f:tl/ocf}iflwx?sf] b[9tfsf;fy pTkfbg /

u'0f:tl/otfsf] lgoGq0fsf] k|Tofe"ltub{5 .Good manufacturing practice is that part of quality

assurance which ensures that products are consistently

produced and controlled to the quality standards

c;n pTkfbg cEof;-hLPdkL_(GMP)?

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hLPdkL d'Vo?kdf cf}iflw pTkfbgsf]

bf}/fgdf cfOkg]{ vt/fx?nfO Go"lgs/0fsf]sfo{df nlIft 5 .GMP are aimed primarily at diminishing the risksinherent in any pharmaceutical production.

vt/fx? Ps cf}iflw;+u csf]{ cgfaZos cf}iflwsf]ld;fj6cross-contamination (in particular of unexpected contaminants) Ps cf}iflw csf]{ cf}iflw;+u ldl;g' / Pscf}iflwnfO csf]{ cf}iflwelg n]an ul/g' mix-ups(confusion) caused by, for example, false labels being put on containers and

cfsZos dfqf eGbf clt sd jf clt a9L ;ls|o

tTj eO k|efasf/L pkrf/ gx'g' jf grflxbf] c;/' '

c;n pTkfbg cEof;-hLPdkL_(GMP)?

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hLPdkLsf] ;fwf/g k[i6e"ld(GENERAL BACKGROUND OF GMP)

hLPdkLn] cf}iflwsf] u'0f:tl/otf, sfo{ Ifdtf/ ;'/lIfttfdf 7'nf] e"ldsf v]Nb5 h'g hg:jf:Yodf k|ToIf ;/f]sf/ /fVb5GMPplays vital role in quality,efficacy and safety of drugs - a matter of concern for the public health

hLPdkLn] d'Vo?kdf cf}iflw pTkfbgsf]bf}/fgdf cfOkg]{ vt/fx?nfO Go\lgs/0fsf]sfo{df nlIft ub{5 h'g tof/L a:t'sf]kl/If0faf6 yfxfkfpg ;lsb}g GMP rules - directed todiminishing risk, inherited in drug production, that cannot be prevented by end product

testing

hLPdkLsf] cawf/gf cg'?k cf}iflwsf]u'0f:tl/otf ;'?b]lv agfOPsf] x'g' kb{5 gsL

kl5 yKg ;lsG5 Quality must be built into the product, Quality cannot be

inspected into the product

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hLPdkL]sf] ;fwf/g k[i6e"ld(GENERAL BACKGROUND OF GMP)

hLPdkLn] la/fdLn] u'0f:t/lxg cf}iflwslxNo} gkfcf]; eGg] cawf/gf /fVb5

hLPdkLn] cf}iflw lbg] / pTkfbgug]{ ;+:yfk|lt la/fdLsf] bl/nf] laZjf;sf] lasf;ub{5

hLPdkLsf] cawf/0ffn] cf}iflwsf] hf+rk|ls|ofdf /x]sf l;ldttfaf6 u'0f:t/dfkg{ ;Sg] gsf/fTds k|efasf] Go"lgs/0fdf

dxTjk'g{ e"ldsf v]Nb5

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hLPdkLsf cfwf/e"t cfaZostfx?(BASIC REQUIREMENTS FOR GMP)

!=:ki6?kdf k/Leflift, k|0fflnut?kdfn]lvPsf] pTkfbg lalw Clearly defined, systematicallyreviewed manufacturing processes

@=oGqx?sf] of]Uokg / pTkfbg oGq jfsfo{ lalwsf] pko'Sttf l7s 5 elg ul/g] k|ls|ofQualification and validation

#=;\xfpbf] >f]tx?M dflg;, pTkfbg If]q,oGq, ;fdfg, k|ls|of / lgb]{zgAppropriateresources: personnel, premises, equipment, materials, procedures and

instructions

$=:ki6?kdf lnlvt k|ls|ofClearly written procedures

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hLPdkLsf cfwf/e"t cfaZostfx?(BASIC REQUIREMENTS FOR GMP)

^=k'0f{ clen]v k|0ffnLComplete record system&=pko'St e08f/0f / lat/0f k|0ffnLProper

storage and distribution

*=pTkfbg lkmtf{lng] k|0ffnL Recall system

(=l;sfot ;DxfNg] k|0ffnLSystem for complaint handling

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!=;/;kmfO{ / :j:Yotf(Sanitation and hygiene)pTkfbgsf] x/]s s'/fdf pRr:tl/o

;/;kmfO{ / :j:Yotfsf] cEof;ug'{ kb{5 . ;/;kmfO{ / :j:Yotfsf]cEof;sf] bfo/fleq AolStut ;/;kmfO{,pTkfbg If]q, pTkfbg oGq, pTkfbgdf k|

of]u ul/g] kbfy{x? / at{gx?, ;/;kmfO{ /lhafg'gf;ssf] nflu rflxg] a:t'x? / cgfaZosld;fj6sf] >f]taGg] s'g}klg lrh cflb kb{5 .A high level of sanitation and hygiene should be practiced in every aspect of themanufacture of drug products. The scope of sanitation and hygiene coverspersonnel, premises, equipment and apparatus, production materials andcontainers, products for cleaning and disinfection, and anything that could become asource of contamination to the product. Potential sources of contamination should

hLPdkLsf] d"Vo c+zx?(PRINCIPAL COMPONENTS OF GMP)

hLPdkL dflyNnf] Aoa:yfkg tyf pTkfbg

/ u'0f:t/ lgoGq0f Aoa:yfkg kIfsf] ;+o"St lhDd]jf/Lsf] sfd xf] .Joint responsibilitiesof top management and of production and quality control management)

h dk f] d

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@=of]Uokg / pko'Stkg(Qualification and validation)

hLPdkL cg'?k k|To]s cf}iflw sDklgn]pTkfbg sfo{ k4tLsf] ;+a]bglZfn kIfx?cfaZostf cg';f/ lgolGqt 5 elg l;4

ug{ cfaZoskg]{ of]Uokg / pko'Stkg;DalGw sfo{sf] klxrfg ug'{ kb{5 .sDklgsf] of]Uokg / pko'Stkg ;DalGwsfo{s|dsf d"Vo tTjx? :kI6?kdf kl/eflift

ug{'sf] ;fy} pko'Stkg u'? of]hgfdfclen]lvt ul/Psf] x'g' kb{5 .In accordance with GMP, each pharmaceutical company should identify what

qualification and validation work is required to prove that the critical aspects of their

particular operation are controlled. The key elements of a qualification and validation

programme of a company should be clearly defined and documented in a validationmaster plan

hLPdkLsf] d"Vo c+zx?PRINCIPAL COMPONENTS OF GMP

h dk f] d

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#=l;sfot Aoa:yfkg(Complaint Handling);a} l;sfot / cf}iflwsf] v/flakg;DalGw ;"rgfx?nfO{ lnlvt sfo{lalw cg'?k/fd|f] tl/sfn] 5fglag ul/ ;Rofpg] sfd ug{'

kb{5 .All complaints and other information concerning potentially defective productsshould be carefully reviewed according to written procedures and the corrective

action should be taken.

$=pTkfbg lkmtL{ (Product recalls)u'0f:t/df v/fla5eGg] yfxf ePsf jf ;+vf:kbePsf cf}iflwx?nfO{ ahf/af6 t'?Gt} lkmtf{ lng] Aoa:yf x'g' kb{5 . Thereshould be a system to recall from the market, promptly and effectively, products

known or suspected to be defective.


h dk f] d ?

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%= Zjlg/LIf0f / u'0f:t/cl86 (Self-inspection andquality audits)

Zjlg/LIf0fsf sfo{s|dnfO{ lgoldt ;dosf]cGt/fndf lhPdkL nfu''ug]{s|ddf x'g]sldsdhf]/Lx? kQfnufpg] / cfaZos cg?k;Rofpg] sfo{sf] l;kmfl/; ug]{ ul/ l8hfO{gul/Psf] x'g' kb{5.The purpose of self-inspection is to evaluate the manufacturers compliance with

GMP in all aspects of production and quality control. The self-inspection programme

should be designed to detect any shortcomings in the implementation of GMP and

to recommend the necessary corrective actions with regular interval.

u'0f:t/cl86 eGGffn] u'0f:t/ clea[lw ug]{ x}l;otn] u'0f:t/ k|0ffnLsf k'/f jf cf+lZfsefusf] kl/If0f ul/g] sfo{nfO hgfpb5 .

u'0f:t/

cl86 ;fwf/gtof Aoa:yfkgn] ;+:yfaflx/sf : tG la1x?nfO{ ;dfa]; ul/


hLPdkL f] d"V ?

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^= cfaZos AolStx?(Personnel)

pTkbsn] lhDd]jfl/k'a{s ug{'kg]{;Dk'g{ sfdsf]nflu cfaZosdfqfdf of]UoAolStx?sf] Aoa:yf x'g' kb{5 . k|To]ssf]AolStut sfo{;+Dkfbg lhDd]jf/L{ :ki6?kdf

kl/efliftul/Psf], ;DalGwt AolStn] /fd|/La'em]sf] / lnlvt clec]v /flvPsf] x'g'kb{5.There must be sufficient qualified personnel to carry out all the tasksfor which the manufacturer is responsible. Individual responsibilities should beclearly defined and understood by the persons concerned and recorded as writtendescriptions.

&= k|lzIf0f(Training)pTkfbg sfo{df ;+nUgx'g];Dk'0f{ AolStx?nfO{ cfaZos 1fg / l;kaf/]

pTkfbsn] lnlvt sfo{s|d cg'?k ;do ;dodf k|lzIf0f k bf u '{ kb{5 . The manufacturer should provide


hLPdkL f] d"V ?

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*= AolStut :jf:YoPersonal hygienepTkfbg sfo{df ;+nUgx'g];Dk'0f{ AolStx?nfO{ sfdug{ clw /sfdul//x]sf] ;dodf :jf:Yo kl/If0f u/fpg'kb{5 . cf}iflwsf] b[li6ut k/Lif0f ug]{ AolStx?sf] ;fdlos cfvf+ hf+r u/fpg'kb{5 .All personnel, prior to and during employment, as appropriate, should undergo

health examinations. Personnel conducting visual inspections should also undergo

periodic eye examinations.

(= pTkfbg If]qPremisespTkfbg If]qsf] :Yffg lgwf{/0f, 9f+rfsf]

agfj6, ejg lgdf{0f, dd{t;Def/sf sfo{x?+rfn 'xf bf x' ' kb 5 . Premises must be


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Smooth curvature corners and smooth finished floors

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hLPdkL f] d"V ?

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!)= oGq EquipmentpTkfbg oGqsf] :Yffg lgwf{/0f, :Yffglgwf{/0f, 9f+rfsf] agfj6, ejg lgdf{0fdd{t ;Def/sf sfo{x? ;+rfng ;'xfpbf] x'g'kb{5 . oGqx?sf 9frf+sf] kl/sNkgfUfbf{ vt/fx?sf] Golgs/0f ug]{ / s|;sG6fldg];g x'g glbg k|efazfln ?kdf;kmf / dd{t ;Def/ ug{ ;lsg] x'g' kb{5 .Equipment must be located, designed, constructed, adapted, and maintained tosuit the operations to be carried out. The layout and design of equipment must aimto minimize the risk of errors and permit effective cleaning and maintenance inorder to avoid cross-contamination, build-up of dust or dirt, and, in general, any

adverse effect on the quality of products.

!!= kbfy{x? MaterialspTkfbg If]qsf] :Yffg lgwf{/0f, 9f+rfsf]

agfj6, ejg lgdf{0f, dd{t;Def/sf sfo{x? ;+rfn 'xf bf x' ' kb 5 .


hLPdkL f] d"V ?

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!@= b:tfe]h k|:t'tLs/0fc;n b:tfe]h k|:t'tLs/0f u'0f:t/ k|Tofe"tsf]Ps cltcfazos c+u xf] . b:tfe]h k|:t'tLs/0faf/] lhPdkLsf]] cawf/gf o;lsl;dsf 5,h:t}M

h] ug{ n]lvPsf] 5 Tof] cg';f/ ug'{/

h] ul/Psf] 5 Tof] n]Vg' .Good documentation is an essential part of the quality assurance system and, assuch, should exist for all aspects of GMP. DO WHAT YOU WRITE AND WRITE

WHAT YOU DO


PRINCIPAL COMPONENTS OF GMP

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!#=pTkfbg If]qleqsf] s"zn cEof; Good practices inproductionpTkfbg ;+rfng k|ls|of u'0f:t/oSt cf}iFlw

pTkfbgsf] p4]Zo /flv pTkfbg / lals|lat/0fsf]nflul;kmfl/; ug]{ ;+:yfsf] -h:tM} cf}iflw Aoa:yflaefusf]_ cfaZostf cg';f/ :ki6 ?kdf kl/efliftsfo{lale cg'?k ug{' kb{5 . Production operations must followclearly defined procedures in accordance with manufacturing and marketing authorizations,with the objective of obtaining products of the requisite quality.

!$= u'0f:t/ lgoGq0fdf ul/g] s"zn cEof; Goodpractices in quality controlu'0f:t/ lgoGq0f hLPdkLsf] Ps c+z xf] h'g gd'gf ;+sng, u'0f:t/ laa/0f, kl/If0f sfo{;+u ;DalGwt5 . ;fy} u'0f:t/ lgoGq0f eGgfn] cf}iflw jf cf}iflwpTkfbgdf k|of]uxg] kbfy{sf] cfaZos kl/If0f /clen]iF k|ls|of k'/f ul/ u0f:t/ ;Gtf]zhgs ePkl5 dfqahf/ lals|sf]nflu jf cf}iflw pTkfbgdf k|of]usf]nflukm's'jfug]{ sfdnfO{ hgfp+b5 . Quality control is the part ofGMP concerned with sampling, specifications and testing, and with the organization,

documentation and release procedures which ensure that the necessary and relevant testsare actually carried out and that materials are not released for use, nor products releasedfor sale or supply, until their quality has been judged to be satisfactory. Quality control is not


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k|To]s cf}iFlw pTkfbg sDklgdf u'0f:t/ lgoGq0flaefu x"g} k5{ . Each holder of a manufacturing authorizationshould have a QC Department

u0f:t/ lgoGq0f laefusf] pTkfbg / cGo laefux?af6 :jfwLg x'g' kb{5 . Independence from production andother departments is considered to be fundamental

u'0f:t/ lgoGq0f laefusf Ps jf al9 lgoGq0f k|of]uzfnfx? Ps pko'St of]Uotf / cg'ea ePsfAolStsf] clwsf/ cGtu{t ;+rfng ug'{ kb{5 .Under the authority of an appropriately qualified and experienced person

with one or several control laboratories at his or her disposal.

u'0f:t/ lgoGq0fQuality Control (QC)u'0f:t/ lgoGq0fQuality Control (QC)

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!%=cGo pkof]lu Aoa:yfx? Utilities

cf}iflw pBf]u ;+rfngsf]nflu cfaZoskg]{ laleGgpkof]lu Aoa:yfx? -h:t}M cfaZos aftfg's'n xfjfsf]Aoa:yf, ;'4 kfgLsf] Aoa:yf, ;+kLl8t xfjfsf]

Aoa:yf / laleGg Uof+;sf] Aoa:yfx?_nfO{ cfaZos :6/ / laa/0f cg';f/ ;+rfng /dd{t;Def/ ug{' kb{5 .Different utilities systems such as heating ventilation and air

conditioning (HVAC) system, purified water system,compressed air system and different gas systems requires

for operation of pharmaceutical industry also needs to be in

operation and maintenance as per required standards and

specifications.

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cf}iflw pTkfbgdf k|of]ux'g] kfgLWater for Pharmaceutical Use (WPU)

cGo kbfy{h:t} kfgL lhPdkLsf] l;4fGt cg'?ksf]x'g' kb{5 .Like any starting material, water must conform to GoodManufacturing Practice norms

pkof]lu Aoa:yfx?Utilities

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Water for Pharmaceutical Use (WPU)

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kfgL k|0ffnL 9f+rfWater system design

kfOknfOgdf kfgL gaUg] 7f+px'g' x'b}g

There should be no dead legsolb kfOksf] Aof;

l8= @% dLdL 5eg] kfgL gaUg]7f+p PS; %)dLdL eGbf a9LePdf Tof] w]/}nfdf] dflgG5 . IfD=25mm & distance X is

greater than 50mm, we

have a dead leg that istoo lon .

kfgL gaUg] 7f+pDeadleg section

kfOknfOgdf

kfgL aUg] lbzflrGxsf] dxTjx'G5 Flow directionarrows on pipes are

important

kfgLsf] eNeSanitary Valve


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#=kfgL an eNeaf6 aUbfb"lift xG5 The water iscontaminated as it passes through the

valve

!=an eNex? :jLsf/of]Uo5}g\g Ball valves areunacceptable

@=an eNe aGb ubf{ z"IdhLaf0f' pTkGg x'g ;S5gBacteria can grow

when the valve is closed


cf}iflw pTkfbgdf k|of]ux'g] kfgL

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pRr rfkdf leqk7fPsf] kfgLFeed water under

pressure

kmfNg] jf k'g k|of]u

ug]{drain or recycle

pN6f] c:df]l;;\ sf] l;4fGtReverse Osmosis (RO) Theory


al9 rfkHigh pressure

sRrfkfgLraw water

lem

NnL

Semi-pe

rmeable

mem

brane

sd rfkLow pressure

;'4kfgL

Purified water

;'4 eP/lg:s]sf] kfgLPermeate Water

kmf]x/kfgL RejectWater

(Concentrate)


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pN6f] c:df]l;;\ ROschematic

Outlets or storage.

Air break to sewer

RO

Return to de-ioniser

Cartridge

filter 5 m

Cartridge

filter 1 m

UV light

Ozone generatorRO column

Drain line

kfgLnfO{3'dfO{

/fVg' k5{Water must be

kept circulating

;km6g/af6cfPsf]kfgL

from water softener

:j:Yos/ kDkHygienic pump

cf}iflw pTkfbgdf k|of]ux g] kfgLWater for Pharmaceutical Use (WPU)


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l8cfof]gfOh/De-ionizer

Anionic column

:j:Yos/ kDkHygienic pump

Outlets or storage.

Pl;8HCl ;f]8fNaOH

Eluates to

neutralization

plant

Air break to sewer

;km6g/af6cfPsf]kfgL

from water softener

kfgLnfO{3'dfO{

/fVg' k5{Water must be

kept circulating

1

2345

6

1

23456

Return to de-ioniser

Cartridge

filter 5 m

Cartridge

filter 1 m

UV light

Ozone generator

Cationic column

Drain line

cf}iflw pTkfbgdf k|of]ux g] kfgLWater for Pharmaceutical Use (WPU)

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WHY HVAC ?Heating, ventilation and air-conditioning

(HVAC) play an important role in ensuring the

manufacture of quality pharmaceuticalproducts. A well designed HVAC system will

also provide comfortable conditions for

operators.

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HVAC ?

HVAC system design influences architectural layouts

with regard to items such as airlock positions,doorways and lobbies. The architectural components

have an effect on room pressure differential

cascades and cross-contamination control. The

prevention of contamination and cross-contamination is an essential design consideration of

the HVAC system.

In view of these critical aspects, the design of theHVAC system should be considered at the concept

design stage of a pharmaceutical manufacturing

plant.

ROLL OF HVAC ?

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ROLL OF HVAC ?

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Definition of Conditions

air

as built

air

at rest

air

in operation

HVAC S t R i t (At R t)

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HVAC System Requirements (At Rest)

Class 100000 for Operation Particle > 0.5: not more than 100000 particles per cu ft

Class 100 for Dispensing & Sampling Particle > 0.5: not more than 100 particles per cu ft

Pressure Cascade

Corridor +ve to operating room with 15 Pascal's difference (> 6 Pascals)

Air change per hour:> 20 /hr = Air supplied to room per hour m3/hr (Grill area in m2x

air velocity in m/hr) / Vol. of room in m3

Temperature and Humidity Control 22+/- 3C and

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cfaZos xfjfsf] Aoa:yfHVAC System Requirements

-d'vn] vfg] rlSs / SofK;'nsf] nflu_

pTkfbg If]qsf] nflu Snf; !))))) (Class100000 for Operation)k|To]s So"=lkm6= cfsf/df )=% dfOs|

f]g eGbf 7"nf] s0f ;+Vof !))))) eGbf sdx'g' k5{(Particle > 0.5: not more than100000 particles per cu ft)

1 ft

1 ft

1 ft

)=%dfOs|

f]g eGbf7"nf]s0fx? !

Nffv eGbf

sd

Snf;!)))))

cfaZos fjfsf] Aoa f

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hf]Vg] / gd'gf ;+sng If]qsf] nflu Snf; !))(Class 100for Dispensing & Sampling)

k|To]s So"=lkm6= cfsf/df )=% dfOs|f]g eGbf

7"nf] s0f ;+Vof !)) eGbf sd x'g' k5{(Particle > 0.5:

not more than 100 particles per cu ft)

1 ft

1 ft

1 ft

Snf;

!))



)=%dfOs|

f]g eGbf7"nf]s0fx? !))eGbf sd

cfaZos xfjfsf] Aoa:yf

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Rffk leGgtfPressure CascadepTkfbg sIf eGbf aflx/L bnfg -sl/8f]/_sf] xfjfsf]rfk !% # kf:sn al9 x'g' k5{ -l;ldttfM ( b]lv @!kf:sn_Corridor +ve to operating room with 153 Pascal's difference (9-21Pascals)

rlSs agfpg]sf]7f SofK;n eg]{ sf]&fsl/*f]/xfjfsf] rfk!% # kf:sn

3l6df !@ kf:snaldf !* kf:sn

xfjfsf] rfk#) # kf:snal9df ## kf

3l6df @& kfrfk leGgtfM

al9df ##!@= @!kf:sn

3l6df @&!*= ( kf:sn

xfjf



xfjfsf] rfk!% # kf:sn

3l6df !@ kf:sn

aldf !* kf:sn

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Regulation of room pressure pressure differentials

concept

Room pressure

gauges

Room pressure indication panel

HVAC


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pTkfbg If]qleq xfjfsf] k|afx k|lt 3G6fAir change/hour:sf]7fdf k|lt 3G6f kmof+lsPsf] xfjf-So"=lkm6=k|lt 3G6f_ nfO{ sf]7fsf] cfotg-So"=lkm6=_ n] efu ubf{ cfpg]

efukmnnfO{ To; sf]7fleqsf] xfjfsf] k|afx k|lt3G6F elgG5 -l;ldttfM@) k|lt 3G6F eGbf al9_ .> 20 /hr = Air supplied to room per hour ft3/hr (Grill area in ft2 x

air velocity in ft/hr) / Vol. of room in ft3

10 ft

10 ft

10 ft

xfjfsf] k|afxM)) So"=lkm6 k|lt 3G6f

sf]7f leq xfjfsf] k|afx

=

xfjfsf] k|afx k|lt3G6fsf]7fsf] cfotg

= @)))) So"=lkm6

k|lt 3G6f"




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tfks|d / ;fk]lIft cfb|tfTemperature and Humidity Control;fwf/gtof pTkfbg If]q leq tfks|d !(@% ;]=u|]8 / ;fk]lIft cfb|tf %)% eGbf sd x'g'k5{ Temperature 19-25C and Relative Humidity

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+

pTkfbg sf]7fProduction Room

sf]7fAflx/kmof

+lsPsf]xfjf

Exhaust air

3'dfPsf] xfjfReturn air (re-circulated)

Aflx/af6 lnPsf]xfjfFresh

air

(make-up air)

pTkfbg sf]7fdfk7fPsf] xfjf

Supply

air

xfjfsf] k|sf/Air types



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xfjf axg] cfbz{ tl/sfIdeal Air Flow Pattern

cfaZos xfjfsf] Aoa:yfHVAC System

A DISPENING BOOTH

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A DISPENING BOOTH

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Materials

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Dispensing area and dispensing materials

Materials

HVAC SYSTEM

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HVAC SYSTEM

Rffk leGgtfM

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N o t e : D i r e c t i o n o f d o o r o p e n i n g r e l a t i v e t o r o

1 5 P a

1 5 P a1 5 P a

E3 0 P a

P a s s a g e

0 P a

A i r

L o c k

R o o m 3R o o m 2R o o m 1

1 5 P a

A i r L o c kA i r L o c k

Rffk leGgtfMs|; sG6fldg]zgaf6 arfpgsf]nflu-d'vn] vfg] rlSs / SofK;'nsf] nflu_

Pressure cascade solid: Protection from cross-contamination

sf]7fsf] 9f]sf xfjfsf] rfkn] aGb x'g] x'g' k5{, h;sf]nflu9f]sf sdrfkaf6 al9rfk If]qdf vf]lng' k5[{ .

al9rfk If]q

sdrfk If]q

h dk l d jk f{

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hLPdkL lsg dxTjk'0f{ 5

GMP NEP JBK01 2

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Transcript of GMP NEP JBK01 2