St

eri
l
edosagef
orms

1.Def
ine“
Ster
il
eDosagef
orms”cl
assi
fyt
hem.Whatar
ethei
deal
requi
rement
sfori
t?
2.Out
li
net
hedesi
gnandr
equi
rement
sforpr
oduct
ionar
eaofst
eri
l
epr
oduct
s.
3.Descr
ibef
reezedr
iedpr
oduct
s:i
tspr
oduct
ion&appl
i
cat
ion.
4.St
eri
l
ityi
smai
ntai
nedst
ri
ctl
yinbl
owf
il
l&seal
technol
ogy:
comment
5.“
Wat
erf
orI
nject
ion”
.Pr
epar
ati
on&st
orage,
dist
ri
but
ion,
qual
i
tycont
rol
6.Shor
tnot
eon“
Pre-
fi
ll
edsy
ringes”
7.Wr
it
eabr
iefnot
eonPar
ent
eral
suspensi
ons
8.Whatar
ecleanr
ooms?Di
scusst
hest
andar
dsf
orcl
eanr
ooms.Enumer
atecr
it
eri
aforenv
ironment
al
moni
tor
ingofcl
eanr
ooms.
9.Wr
it
eanot
eoncont
ainer
sandcl
osur
esusedf
orpar
ent
eral
product
s.
10.Expl
ainv
ari
oust
ypesofaddi
ti
veswhi
char
eusedi
npar
ent
eral
prepar
ati
ons.
11.Di
scusst
heev
aluat
ionpar
amet
erofpar
ent
eral
dosagef
orm.
12.Expl
ainsour
cesofcont
ami
nat
ionandmet
hodsofpr
event
ioni
nst
eri
l
epr
oduct
.
13.Descri
beinbri
efwi
thr
efer
encet
ost
eri
l
epr
oduct
ion:
Asept
ict
echni
ques,
sour
cesofcont
ami
nat
ionand
i
tsprevent
ion.
14.Wr
it
eadet
ail
not
eonadv
ancesi
npar
ent
eral
packagi
ng.
15.Descr
ibei
nshor
t:Par
ent
eral
nut
ri
ent
s,Fr
eezedr
iedpar
ent
eral
product
s
16.Di
scussi
nbr
iefaboutocul
ari
nser
tsf
oropht
hal
micuse.
17.Descr
ibequal
i
tycont
rol
test
sofpackagi
ngmat
eri
alsusedi
npar
ent
eral
s.
18.Wr
it
eanot
eonFFSTechnol
ogy

Li
qui
ddosagef
orms

1.Gi
vecl
assi
fi
cat
ionofLi
qui
ddosagef
orm.Enumer
atef
ormul
ati
oncomponent
swi
thi
tsuse.

2.Wr
it
eanot
eon“
Sol
ubi
l
ityEnhancer
s”and“
Vehi
cles”
.

3.Enumer
ateev
aluat
ionpar
amet
ersofsuspensi
onsanddi
scusst
hepr
ocedur
es.

4.Di
scussi
)Mi
cro-
Emul
sions&i
i
)Mul
ti
pleEmul
sions.

5.Wr
it
eadv
ant
agesanddi
sadv
ant
agesofl
i
qui
ddosagef
orms.

6.Wr
it
eimpor
tanceoff
oll
owi
ngi
nli
qui
ddosagef
orm:
stabi
l
izer
,pr
eser
vat
ives&v
ehi
cle/
sol
vent
.

7.Di
scussv
ari
oust
echni
quesf
orsol
ubi
l
ityenhancementi
nli
qui
ddosagef
orms.

8.Wr
it
erequi
rementofi
deal
biphasi
cli
qui
ds.Descr
ibeev
aluat
iont
est
sforsuspensi
on.

9.Expl
aini
nbr
ief
:ext
ract
s,t
inct
ure,
inf
usi
onwi
thexampl
es.

10.Descr
iber
oleofeachcomponenti
nfor
mul
ati
onf
orcl
earl
i
qui
d.
11.Def
ineEmul
sion.Wr
it
eashor
tnot
eon1)Mi
croemul
sion,
2)Ext
ract
.
12.Classi
fyl
i
qui
ddosageforms.Descr
ibei
nbr
ieft
hef
ormul
ati
oncomponent
sofcl
earl
i
qui
dswi
tht
her
ole
ofeachcomponenti
nthefor
mula.

Semi
sol
i
ddosagef
orms

1.Expl
aint
hemechani
sm ofdr
ugpenet
rat
iont
hroughski
n.Wr
it
eashor
tnot
eonper
meat
ionenhancer
s.

2.Classi
fyr
out
esofdr
ugpenet
rat
iont
hroughski
n.Di
scussf
act
orsi
nfl
uenci
ngpenet
rat
ionofdr
ugst
hrough
skin.

3.Di
scussi
nbr
iefsupposi
tor
ybases&cl
assi
fyt
hem.

4.Enumerateideal
char
acter
ist
icsofsupposi
tor
ybases.Descr
ibeanyonemet
hodofmanuf
act
uri
ng
supposi
tori
esindet
ail
.

5.Di
scussi
deal
proper
ti
esofsupposi
tor
ybase.Wr
it
eashor
tnot
eonsupposi
tor
ybases.

6.Expl
ainqual
i
tycont
rol
test
ingofsupposi
tor
y.
 7.Expl
aini
nbr
iefDi
spl
acementv
alue.Enumer
atei
deal
char
act
eri
sti
csofsupposi
tor
ybases.

8.Descr
ibet
ypesofoi
ntmentbases&Howi
tcanst
eri
l
ised?
.

9.Di
scussi
nbr
ieft
heev
aluat
iont
est
sformedi
cat
edoi
ntment
.
10.Expl
ainf
ormul
ati
onandev
aluat
ionoft
oot
hpast
e
11.Wr
it
eabr
iefnot
eongener
alf
ormul
ati
onf
orsemi
sol
i
dpr
epar
ati
ons

Phar
maceut
ical
aer
osol
s

1.Dr
awwel
ll
abel
eddi
agr
am f
oraer
osol
packs.Expl
aint
hedi
ff
erentpar
tsofi
t.

2.Rol
eandpr
oper
ti
esofpr
opel
l
ant
s.Di
scuss.

3.Def
ineAer
osol
s.Gi
veabr
iefaccountofpr
opel
l
ant
s.
4.Di
scussev
aluat
iont
est
sforphar
maceut
ical
aer
osol
product
s.
5.Wr
it
eappl
i
cat
ionsofPhar
maceut
ical
Aer
osol
s
6.Enl
i
stv
ari
ouscont
ainerusesf
orAer
osol
.Expl
ainv
ari
oust
ypesofact
uat
orandv
alv
eusedi
naer
osol
7.Descr
ibei
ndet
ail
qual
i
tycont
rol
forphar
maceut
ical
aer
osol
spr
oduct
s.
8.Classi
fypropel
l
ant
sanddescr
ibel
i
quef
iedgaspr
opel
l
ant
sinbr
ief
.Di
scusst
her
oleofpr
opel
l
ant
sinan
aerosolsy
stem.
9.Dr
awwel
ll
abel
eddi
agr
am f
orpr
essur
izedpacks.Expl
aindi
ff
erentpar
tsofi
t.

Cosmet
icol
ogyandcosmet
icpr
epar
ati
ons

1.Requi
rementandpur
poseofsun-
scr
eenl
oti
ons.Cat
egor
ies&Cl
assi
fi
cat
ion.
2.Enl
i
stpr
oduct
scov
eredundercosmeceut
ical
s.Expl
ainshampooi
ndet
ail
s.

3.Expl
aini
nbr
ieff
orf
oll
owi
ngcosmet
ics:
mani
cur
epr
epar
ati
ons,
hygi
eni
cpr
oduct
s,Makeuppr
epar
ati
ons.
4.Enl
i
stv
ari
oust
ypesofHai
rpr
oduct
s,wr
it
epr
epar
ati
on&ev
aluat
ionofshampooandcondi
ti
oner
s.
5.Cl
assi
fycosmet
ics.Wr
it
eshor
tnot
eont
oot
hpast
e.
6.Di
ff
erent
iat
ebet
weenVani
shi
ngandcol
dcr
eam.
7.Wr
it
ebr
iefnot
eofv
ari
ousbabycar
epr
oduct
s.
8.Wr
it
eabr
iefnot
eonant
idandr
uffshampoo
9.Whatar
esunscr
eenpr
epar
ati
ons?Di
scusst
hei
rfor
mul
ati
onandev
aluat
ioni
nbr
ief

GoodManuf
act
uri
ngPr
act
icef
orPhar
maceut
ical
sandv
ali
dat
ion
1.Whatdoy
ouunder
standbyv
ali
dat
ion?
2.Br
ief
lyout
li
neschedul
e-M.
3.Whati
sthei
mpor
tanceofDocument
ati
oni
nGMP?
4.Wr
it
eanot
eon“
Recov
ery&Repr
ocessi
ng.
”

5.Def
inev
ali
dat
ion.Wr
it
eanot
eonv
ali
dat
ionofst
eam st
eri
l
izat
ion.

6.Descr
ibeschedul
eM r
equi
rementofGMPpl
anti
nphar
maceut
ical
Indust
ri
es.

7.Wr
it
eashor
tnoton:
SOPs,
Dent
if
ri
ce,
Past
e

8.Enumerat
edif
ferentt
ypeofrecor
dmai
ntai
ninPhar
maceut
ical
companyasperGMP.Wr
it
eshor
tnot
ein
batchmanuf
acturi
ngrecor
d.

9.Def
ineSOP.Expl
ainSt
andar
dOper
ati
ngPr
ocedur
ewi
thf
ormat
.

10.Descr
ibet
hepr
emi
sesf
aci
l
ityr
equi
rement
sasperGMP.

11.Whati
sSOP?Descr
ibei
tssi
gni
fi
cance