GMP NEP JBK01 2
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Transcript of GMP NEP JBK01 2
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c;npTkfbgcEof;-hL=Pd=kL=_
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c;npTkfbgcEof;-hL=Pd=kL=_
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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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02.10.2010 GPANGMPQSTNEP JBK 1001 5
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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02.10.2010 GPANGMPQSTNEP JBK 1001 6
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.
hLPdkLsf] d"Vo c+zx?PRINCIPAL COMPONENTS OF GMP
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/
hLPdkLsf] d"Vo c+zx?PRINCIPAL COMPONENTS OF GMP
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
hLPdkLsf] d"Vo c+zx?PRINCIPAL COMPONENTS OF GMP
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
hLPdkLsf] d"Vo c+zx?PRINCIPAL COMPONENTS OF GMP
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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 .
hLPdkLsf] d"Vo c+zx?PRINCIPAL COMPONENTS OF GMP
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
hLPdkLsf] d"Vo c+zx?PRINCIPAL COMPONENTS OF GMP
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
PRINCIPAL COMPONENTS OF GMP
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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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PRINCIPAL COMPONENTS OF GMP
!%=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
cf}iflw pTkfbgdf k|of]ux'g] kfgLWater for Pharmaceutical Use (WPU)
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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] kfgLWater for Pharmaceutical Use (WPU)
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
cf}iflw pTkfbgdf k|of]ux'g] kfgLWater for Pharmaceutical Use (WPU)
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)
cf}iflw pTkfbgdf k|of]ux'g] kfgL
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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)
cf}iflw pTkfbgdf k|of]ux'g] kfgL
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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;
!))
cfaZos xfjfsf] Aoa:yfHVAC System Requirements
-d'vn] vfg] rlSs / SofK;'nsf] nflu_
)=%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
cfaZos xfjfsf] Aoa:yfHVAC System Requirements
-d'vn] vfg] rlSs / SofK;'nsf] nflu_
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
cfaZos xfjfsf] Aoa:yf
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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"
cfaZos xfjfsf] Aoa:yfHVAC System Requirements
-d'vn] vfg] rlSs / SofK;'nsf] nflu_
cfaZos xfjfsf] Aoa:yf
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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
cfaZos xfjfsf] Aoa:yfHVAC System Requirements
cfaZos xfjfsf] Aoa:yf
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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