QA 2 Marks Solution Carewell Pharma

Page 1 of 19
Carewell Pharma - A Family of Learning

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SOLUTION S
Qualidy (ontol Qualil-Assurance

a
m
DuHnhM
Ts T is u procAs to
to
and
ensuR
punty
tu
of
ldentity
a OF of
t
r quality
manufachurtd
h
any
pharmacautical produds produc.
Covol
throughouf
managn quallt
Maufadtulug.
l P Chutk AssURu qualsty
l
after is Conmplekq.
e
Obtrcie
petablishad tu AssUd t qualtq of
desitd qualit rau
w
standods which maleual and of
accuptabl to tu fíishad produc
r
Consu
fird e Hlau)s + vauahins

Also Manag CaLP
a
GMP
lfiza
Reponsibls tor day-to-
C
Reyponst
tMsUe propur
wahovsing
Cowtrol of qually
da pochcLa Maufocuring
Responsibls jor andluyticol proAL Qud prou tudk
sting of rou malenalu, Respontibl for mak
making
ing master
pocRaqug Conponurts
el-. plan, Mabilily tuhnq,
shlf
uk evaluahn et
www.carewellpharma.in (free notes)

Visit & Download Notes
Page 2 of 19
Quauly?
Tis definud a produc wih
a
Zo defet oK phoducr
tha uus
"Custonur satisfachion
T refes deqee oF excellen
r m
MP
Good Manufoctuvijng
h aPrachicus
Tis
thu
t pat
pot Of
oF
l P A which ensue thar
l
products ak Consis tont4 producad and Cotrolled
e
quality
Occokding standavd
or heir indendud
u
Tt
followed
e w
is
by
eF prinuplu
Manufactures
fo
and
t
protudUAD which
horapeutic qoods
a r Quali fhudi-/moniloring
C ofa
Tis
qualiy syskem
prous of
Carried Ou
syshemic
hy
examinahion
indcna or exnod audio an

C auduF tcam.
T rs a koy elemont in th ISO qualisystem Std

Page 3 of 19
TAM Total Qualily Manage man
ot of hond liug. t wole to
achieve pyfechon.
a
m
T main fows oF TaM is to Coninuo US
r
quality inmprovemAn in th aHa of produt|
SAvl
businuts
Emplouu-tmployu
elahms
h a latin Cnd wstomt
Ixonahona
l P
Conferan d on
l
tHormontaation.
e
Ts a4
pln asSociadton whh Invdves pvT.
ndushy and govt Hgulaton bodic toguthur a
OF
qua
e wpotr n
toting proudun
Stiedific
whch
ond
Cqufed
tcchal diswss
to ensu
a r t queldq safdt and etia ofmdlcinu
C
purpoSA
th man Purpou to ovqai su TUH is thalhdomeu
bagudy in 196o' In Eorop thus orqanisu
rapid inoeatu u and quudlinu for
evalvohing data on quai,
TA saft efficay

Page 4 of 19
o nw udicinal
Of prodwd.
stprultrgudlriu -h
ASEM
a
m
pon ot TH whidh includ
Tt is quud uw
S
Saf
a r
h
E Eicacu
Mulidiscdplinany
P
M
(
BD
l l
Qualit
e
by Deign
w
prous fov developmu
isa sttareqic
e
manusocing of phamacautical produds
Ond
a r
with
Systtmatic approadn
pkduindobjecives
b
and
develepmunhat bgíns
emphasizs prodve
C cotiol,
proCLs unduanding and pro LAs
ond
basud SOUng scena qualily risk

Managumu.

Page 5 of 19
Jntemodiono dqausotin of Mndardiz4¥m
Tso) qo0o
family OF Standords thol OH
related
t qvalily Managmut sM
a
TO
t
QO00
helbs
Certify
a
t
Conpany
Compay
to SodisFy
s
r m
abouf As qvalm
wstoms
Tt
Conmplek
providu
qurae of
bass lerel
h a
qualit
of qualuhy suystoM, nota
l P
relatd
It
to
Isfamily
t
e l of
Environmbqad
standards ta ae
ManagmntSyshkm.
TPs Man
e w fows
Cleant, Sau
on environm
healthcir
thus
wovld
encoUVag ing
tor all of ys.
a r NABL
C Nationod-Accrdiation
Spe cifiea
Calijbration
Board
laborotori
or cating an
th qoral Hqui-emo for t

Compatonca to Carry
outt and Calibrdhion including
Sampling

Page 6 of 19
Tprovids nationa and intendtional Logisahin.
certifcertify t laboatou..
aas a
m
Steile
a Pumds na cean aRa, desighsd,
r
is
a
Cônstwckd Seviud awd usid olth an lndenin
h
pHent t micobial contaminatn of- produc.
T is also free from altyps of cotaninatim.
l P
£nvironmutl cordol
e l indiodts th edie SuvroUnding .

TF
w
Incdudos biological, physlcal +Socal thingk peLnf on
e
+he eath
r
Phavmacwtic manufactuin plov omoUnt
produds
lar
a
o wast mafeal ha pollue he environmL.
C
TF should toke appropue Atp to redvL aste
marejal, to edvca Consunphion of haud Maltasal
au Col tu polluttm
T Can be tmant by- Phusical ChuCa aud

Brologi
te e

Page 7 of 19
Comunnahn CDvrol
Contamination is t PeCunu any fovelgn
a
Substana n tu produdF SUth a dit, dust,
Pollan sports, bacttala eek
To COvol t COna nahn in steile
r
aa
m s
T
u
Con
pope tool
CArol
duiqnd
ey
h a
Pevtn Cros cotainahin.-
l P
Personne) >
Person
e l who is tesponsibia for
w
Manufactuing, procu[n, pockagung and handing
e
of drug products shovld Provicded with adsguati
r
ex perienu dehinnd as
edvcsion, ainn9 and
a
Purson.
C
Orqcnizotim >
fn oqanjsatiM , is n eti SUch

Copany
Cpany
Instithon o an assoclahon Compvisin4 o or
MOR paopla and navlu a pouticulas purpos
( Corpany, Tuitda TS0 ee.

Page 8 of 19
Mattal Managgmu >
Ttis a siexhifie
tchngu,COnCud
wi
Materfal
planing
fom
, oganaing ad Cool of flow
of
a
m
heiv inihal puvchase destinatin
r
CoMponS /tlomaa
a
.Doyond efimatin
h
Tdeify udud tu
P
Calcuale from th endu in COMJunAptim
duving
l0bt yo
l
2
l
Revitu wih HSOUHA (Constpaícts. "diar
e
w
SouD of impunuties »
r e Ra maeajals, Chonical
instolbili,
a
Keschm with coainu elenws manufatui
72
haanbdu COSS Couqaminatin T;
C
muobial Cataminahon.
Pvimay pockagn
Tt is
t pockaginhas direct
Contac with Usabla o Conumalaklu produc

Page 9 of 19
you ak Cllung
Secondau paagng
tu pockagong tha pulls
a
T is
toquthur all primOAYpatkagimg fom of

a slgla Product
r m
a
Secgudony
pQckagp
h
Paimaay
Pwdu
l P
l
CGlass
Tt is stomg
sthmg vigd chucall4, inu
impuuablu
e
avd possessus protcctive qualitie
ctaseay
e w Typ-I Typl -IL
a r Nutral o borocilicake
qlas (Highly)
Teattd
Glaus
Soda linL
C
KAsnt)
Typs-T Typa -I
Soda Iime Gextal PurporA Soda
glas linu gla

Page 10 of 19
Qvaluty Cbol tkts for 9lass toains

Chuna Reuistaut tet
Powdeed qlat faF-chfaily ?
a
teF
m
Wakt atpck duals ?9
Hydaolyhic
fArsenic tF
Reistanta teut
a r
Thumal hetk t
h
P
GThfomal bustig peux tst
l l
e
Walt Atadk tes
Tha pindipla involved in u tesFis to

delemin
e w whth thu alkali leachud fom t surfau
r
of a Containy s wttAin Speaficd linat or nof.
a n Suwfaa of ompovles chtled .
C
* Contair fused wih Sulphu dioxida funs
noustralizu th Sufad alkalf mal chenially ML

tct
utyl kd indicotor Isued to dutoumiu tu
cd poic

Page 11 of 19
Rubbir losues
Atso Enduwn a Rubhw stoppirs
TThuy providu a baurier bafween ud of

a
m
Vlal vial CouenF thus maiain
r
Stoil PHe CoNtN notin
ta
a
SAd
U
(clore) Ctano SUch vials.
h
GLP Giood
l P
LalboratoyProctfca
Tt
p'ovidus a
a
e
frama
l qualil
wOvR
Managg muW_Susttm,
wiin which t
tha
w
laboratony
e
sfudyes plannud puformud
r
MOnitod and kpoutcd
a
C Cowtol avticlus TeF adidus)
Thu idetiy steug, puuly ond
Composition othor characestia which wil
appopy latly dufina tufo Corol aticus.

Page 12 of 19
determinud for edh bafch
chal bt ad
ghall b docwmeq.
Test Systems
a
m
includus Chenica ond blological
Tt Physical,
r
yston
Re cods OF
Coudahions
COUKA
of
doe
tef
h a o
ystons
arivad and arrival
P
Cleaning Saviizatin of Covtainos
l l
e
(Non-clinital) laboratohy stud
study
w
exdudu frdd TnEs aK expeimus in which tst
e
in
ia avtide studied prospuctivdly In
t ystm
Oimals
r
Undur laboraton COnditins deoninn hir
a
voF povids
dirtcr
C
duoasis, butmot o
Phanmacuial Coplants
is tu stake mant to u

Page 13 of 19
Sonmathing9 wron
wrong Or nor g00 enovgh whjch Shows
dis-satwactin abou u Company and
a
prodwds.
clacsery
m
P Complaints
(rtio
Coplaiut
Maor
a r dufects
h
CoMplaials
anaoobial Contanination
laalli Readily visiblu
P
misinfovmahon
ofr a Sfviu podue- clgu fault..
l l
e
Plcouticol phodwds b mav
Can klurd fom
w
for varlous FEakons qualuty Aoblumu, aridevtal
e
davnag of qodu.
r
fAffe Reom
a
- Physicolly examins th Condihn of tefum good 4
alto uk th dowm
C fHso
t
&c
good
depatmont
+oa a
examna
decision
u quality of
fny acion Jaken Skould b4

RCOds.

Page 14 of 19
Handling ofF Recalling
mans fivms
a
Kecall enoval or (onechim
of a Mavkekcd produc food and druq
m
Adrmi nistrhion COMsidekd p be in viol atijn of t
would itae
adistrs
legal
taqainsF
a actiuities
wwch
r tu 0gnay
h
P
Chsuky (Recall)
l
Class T Serious advese health concuqueneus
/ Dealh
Clas
e l
Hemporan
advea
or udially
halh
evexjbll
conceguenw
e w
Clas L»
toutan Oorcets tha poru a physicol hazads.
28)
a rDowmutation
C is
Coutrol,toMinl mizA
a System
visk of
of information
s-jntupieldtin
ad
and ro IMn in Ord Or Casually wwiten

dotwmaation

Page 15 of 19
-Obfechue
provids necusary Jovkjg detals
Keduas thu risk of mistake
Hetps in deceasing botch to batth variations
a
Ratth ormula Retord
r m
dotumans
is
h a wiHth Htord
mayfactuvinqj phoUL
tha
a t defluSuch
l P as prodvdts nama,
l
SIzl , no. OFF batth, ek
Mastr for mula

eRttovd MER)
e w TF is a Masyer dowmoy for ay
r
pharma poduds
catial
a
Tt indudu al nfovmahim
abou u
C
Maufaculng produ phoU fo t produt-.
PAupaud R4 D
dpau

Page 16 of 19
Sop Stondard opaoiug pro udunt
a
of Ovittcn procuduUe
Tt is
exploynng how od SAfdly work wih ha2ardovs
cucals.
o acee
r m
a
main oim eHiciency qualily,
T
of pfomana
h
and uifor mali
Dfis
l P
l
O Calibrahion Tt is t pvocus of detrining
e
tu acwray of instrumat/
equipmo
w
appanafuy ee-
r
MAOUV e frvolves obtaininga
with Standavds.
Hadng, aud
a
C
Validation
T Is HudoCUMUTny evidenca
for determning tu oncistnc of

anolytical muthod and Mau-acujug poc
- perfovmd for watr susten, analytical
ukod-

Page 17 of 19
Scop OF
Validahan
Selection of raw Mafejals

procels
COnsistent
Maleua
yidd of
aMd equipmon to_prove
produ of a
equidualut
r m
Qvalifiation
h a
Contim
tu wwovking
P
Capabdities /ohilt of equipmbt tha t wil
l
pvform routindy adeHcetivey
Qvalufiahn
Cquipman.
e lshall
inatrumufaciki
e Puformad
aud
Or elattd
bufou
to
w
Analtial
e w Muthsd
a r Vali datiom)
T Is proc ot dutermining
C for
Suutabldy
PLoviding
C
Usefu
a given (rmuthodolo9
analuytical
auaduia
data
piLL
-
Resuls from Analufical nukhod validahon Can b
tonsrspncy
usdto Tudg t qualu, kliabl

Page 18 of 19
of analytical eul-
Validahiom Maste plan (vmP)
T is a high -levwel do cum
a
m
an Umbrella validatim plan
tha essaldlishu
r
fov ti_phofc.c and SUmmaujzus
o
Mavufaduv@'s overal
h a philosophy + appuoack
P
Outliu A Punúplu Involved in qualifiatin
o
l
facili ditining thu aras and system tod
for
validattd,
achieving
e
and l and (providu) a
maitaining a
writtn p-Oqvam
qualified facdd
e w
Cali baatiom of pH tty »
imp-7 (s
a r oLv
dh-T
C
Page 19 of 19
wakhouslg
Whon yo purdAas 9ods tom
Manufa ctuuK and stoe hun bufox y
th
a
m
Shipptd anotur locahion for fulfillman
a
r
Malnly laAg plah building
in indu striad aa--
h a
P
CGwP)
God wakhousiaq procicus
l
F Lans stovig Auppliesso tha
producs
aud
a
e l
Qcod
always
Codahm
available, arcossibl
e w
a r A Cut a dots not follow tu tod
C
basud On data alad Colleched with t
Samu COmpomds.
Ondof SPecfiaHon -
A esults -o dots natr omply with
Statd acupted ileia


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Page 1 of 19

Carewell Pharma - A Family of Learning

Qualidy (ontol Qualil-Assurance

l P Chutk AssURu qualsty

fird e Hlau)s + vauahins

www.carewellpharma.in (free notes)

T refes deqee oF excellen

l P A which ensue thar

indcna or exnod audio an

www.carewellpharma.in (free notes)

TAM Total Qualily Manage man

ot of hond liug. t wole to

a r t queldq safdt and etia ofmdlcinu

www.carewellpharma.in (free notes)

basud SOUng scena qualily risk

www.carewellpharma.in (free notes)

tor all of ys.

th qoral Hqui-emo for t

www.carewellpharma.in (free notes)

Tprovids nationa and intendtional Logisahin.

T is also free from altyps of cotaninatim.

e l indiodts th edie SuvroUnding .

T Can be tmant by- Phusical ChuCa aud

www.carewellpharma.in (free notes)

Contamination is t PeCunu any fovelgn

fn oqanjsatiM , is n eti SUch

MOR paopla and navlu a pouticulas purpos

( Corpany, Tuitda TS0 ee.

www.carewellpharma.in (free notes)

Mattal Managgmu >

www.carewellpharma.in (free notes)

toquthur all primOAYpatkagimg fom of

e w Typ-I Typl -IL

glas linu gla

www.carewellpharma.in (free notes)

Qvaluty Cbol tkts for 9lass toains

Tha pindipla involved in u tesFis to

e w whth thu alkali leachud fom t surfau

a n Suwfaa of ompovles chtled .

noustralizu th Sufad alkalf mal chenially ML

www.carewellpharma.in (free notes)

TThuy providu a baurier bafween ud of

Composition othor characestia which wil

appopy latly dufina tufo Corol aticus.

www.carewellpharma.in (free notes)

www.carewellpharma.in (free notes)

dis-satwactin abou u Company and

fny acion Jaken Skould b4

www.carewellpharma.in (free notes)

Handling ofF Recalling

of a Mavkekcd produc food and druq

and ro IMn in Ord Or Casually wwiten

www.carewellpharma.in (free notes)

Mastr for mula

e w TF is a Masyer dowmoy for ay

www.carewellpharma.in (free notes)

Sop Stondard opaoiug pro udunt

exploynng how od SAfdly work wih ha2ardovs

for determning tu oncistnc of

www.carewellpharma.in (free notes)

Selection of raw Mafejals

www.carewellpharma.in (free notes)

T is a high -levwel do cum