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Quality Builtby ProcessAnindita Dhamastri

Feb 2016

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Quality?

Quality is the degree to which a

commodity meets the requirements othe customer at the start o its lie! (ISO9000)

Quality must be maintained so that

e#ery $roducts at e#ery batch meets itss$eci%cation &'(()*(+,*

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-(P +nsure that $roducts are consistently

manufactured and controlled to meet

s$eci%ed quality standards'#erall control is essentially carried out

to ensure consumers recei#e highquality $roducts

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Quality in Pharmaceutical)ndustries

-(P regulations enabling com$anies tominimi.e or eliminate instances o

contamination/ miu$s/ and errors!-(P regulations address issues

including recordee$ing/ $ersonnelquali%cations/ sanitation/ cleanliness/

equi$ment #eri%cation/ $rocess#alidation/ and com$laint handling!

ee more at3 htt$344www!is$e!org4gm$5resources4what5is5gm$sthash!D78r9:&l!1q;D(

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Pharmaceutical )ndustry

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8ow to reduce &'*? =ean manuacturing  being e>ecti#e

and ecient in using e#ery as$ect o

sources!

Built Quality Into theProcess

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9hat can we get i we builtquality into the $rocess?

(inimi.ation o 3 Product re:ect @ewor @e$rocess9aste

Product Qualitymaintained

@etain &ustomer-et new customer(aintain

com$anys goodtrac record

Pro%t

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Quality can be maintained byim$lementing3

C@

PD&A Plan Do &hec ActionE

F(+A Failure (ode +>ects AnalysistE

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&onclusion trictly ollows the conce$t o quality

must be built into the products , since )t

is not sucient that %nished $roducts$ass testing only

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@eerences Anonim/ 2012/ Pedoman Cara Pembuatan

Obat Yan !ai" (CPO!), Badan Pengawas 'bat

Dan (aanan/ aarta!-(P -uidelines! 2016!

htt$344www!is$e!org4gm$5resources4gm$5guidelines

)&8 QG/ Quality @is (anagement!

htt$344www!ich!org4%leadmin4PublicH9ebHite4)&8HProducts4-uidelines4Quality4QG4te$I4QGH -uideline!$d 

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 *8A,J K'L