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The Joint IPEC–PQG Good Manufacturing PracticesAudit Guide
FORPHARMACEUTICAL EXCIPIENTS
Copyright© 2007 The International Pharmaceutical Excipients Council and Copyright© 2007 Pharmaceutical Quality Group
THE JOINT INTERNATIONAL PHARMACEUTICAL EXCIPIENTS COUNCILPHARMACEUTICAL QUALITY GROUP
GOOD MANUFACTURING PRACTICESAUDIT GUIDE
FORPHARMACEUTICAL EXCIPIENTS
Copyright© 2007 The International Pharmaceutical Excipients Council and Copyright© 2007 Pharmaceutical Quality Group
i
ACKNOWLEDGEMENTS
This Guide was prepared by a team from the International Pharmaceutical Excipients Council (IPEC) and the ChartedQuality Institute (CQI) Pharmaceutical Quality Group (PQG).
IPECIPEC is an international industry association formed in 1991 by manufacturers and end-users of excipients. It is an associ-ation comprising three regional pharmaceutical excipient industry associations covering the United States, Europe andJapan (which are known respectively as IPEC-Americas, IPEC Europe and JPEC). IPEC’s objective is to contribute to thedevelopment and harmonization of international excipient standards, the introduction of useful new excipients to the mar-ketplace and the development of good manufacturing practices for excipients.
IPEC first published its GMP Audit Guide for Bulk Pharmaceutical Excipients in 1995 and it was revised in 2004 to alignit with the revised 2001 GMP guide.
For further information see www.ipec.org
PQGThe PQG was formed in 1977 to promote development of a consistent approach to pharmaceutical quality and good manufacturing practice. The group has since expanded and is now incorporated within the United Kingdom’s ChartedQuality Institute.
In 1990 the PQG published three codes of practice to cover pharmaceutical raw materials, printed and contact packaging materials. In 1995 the codes were revised and were integrated ISO 9002:1994. The code for raw materials was revised andreissued as PS 9100:2002 Pharmaceutical Excipients, an application standard and GMP guide for pharmaceutical excipients.
For further information see www.pqg.org
IPEC and PQG greatly appreciate and acknowledge the many hours of hard work the following individuals devoted to creating this Guide and the generous support provided by their employers:
IPEC-AMERICASDale Carter, MS, Archer Daniels Midland Arthur J. Falk, Ph.D., IPEC-AmericasSidney A. Goode, RPh, Pharm.D., The Dow Chemical CompanyMaria Guazzaroni Jacobs, Ph.D., Pfizer, Inc.David B. Klug, MS, sanofi-aventis U.S. LLC.Philip Merrell, Ph.D., Jost Chemical CompanyR Christian Moreton, Ph.D., FinnBrit ConsultingKristin Moore, Archer Daniels Midland Frank Murphy, The Dow Chemical CompanyAnn Perry, The Dow Chemical CompanyPatricia Pranke, International Specialty ProductsDavid R. Schoneker, MS, Colorcon, Inc.Irwin B. Silverstein, Ph.D., IBS Consulting in Quality (committee consultant)Jack Tully, Hercules, Inc.Katherine Ulman, Dow Corning CorporationAnn Van Meter, The Dow Chemical CompanyPhyllis Walsh, Schering-Plough CorporationRobert E. Wiens, MS, Eli Lilly and CompanyPriscilla Zawislak, Hercules, IncRobert Zega, Chr Hansen.
Copyright© 2007 The International Pharmaceutical Excipients Council and Copyright© 2007 Pharmaceutical Quality Group
ii
IPEC-EUROPEPatricia Rafidison, RPh, Ph D.,Dow CorningKevin McGlue, CSci, CHEM, MRSC, Colorcon, Ltd.Iain Moore, Ph D, CChem MRSC, MCQI, Croda Chemicals Europe LtdGianluca Minestrini, Ph D., F. Hoffmann –La Roche
PQGSteve Moss Ph D, MBA, CChem FRSC, MCQI, GlaxoSmithKline
Copyright© 2007 The International Pharmaceutical Excipients Council and Copyright© 2007 Pharmaceutical Quality Group
iii
INTRODUCTION
Purpose and ScopeIn the pharmaceutical industry it is the responsibility of the drug product manufacturer to ensure the quality of all startingmaterials and other components contained in or used in the manufacture of the final product dosage form. Throughauditing the producer of pharmaceutical excipients, a user is able to determine whether adequate controls are in place toensure the producer is capable to manufacture a product of suitable quality. The IPEC-PQG GMP Audit Guide, therefore,is designed as a tool to assist in evaluating the manufacturing practices and quality systems of excipient manufacturers. Itis also a helpful reference to assist excipient manufacturers in meeting appropriate cGMP requirements to assure consis-tent product quality.
The Audit Guide is applicable whenever an excipient manufacturer or subcontractor of excipients is audited. It is intendedto have international application, bearing in mind that production of pharmaceutical excipients covers a diverse range ofdifferent industries and processes which often have uses other than pharmaceutical applications. Although the audit mayinclude other areas such as delivery logistics and order processsing, the Audit Guide is intended only to cover aspects ofcurrent Good Manufacturing Practices relating to excipient manufacture. For auditing of repackagers or distributors, seethe IPEC Good Distribution Practices Guide for Pharmaceutical Excipients © 2006.
Content and UsageThe Joint IPEC-PQG “Good Manufacturing Practices Guide for Pharmaceutical Excipients”©2006 was used as the basisto construct the questions or reminder phrases contained in the Audit Guide, and should serve as the primary source forevaluating responses provided by the auditee. The auditors should be familiar with the introduction, definitions, andgeneral guidance that are contained within the IPEC-PQG GMP Guide, and should refer to the guide if further details are needed.
The Audit Guide is intended to address the foundation of the requirements, and not all of the details, necessary to manu-facture excipients in compliance with applicable GMPs. It may not include all of the appropriate questions / reminderphrases for a specific audit, nor may all of the points be appropriate to every audit. As an international document, it alsocannot specify all national legal requirements, nor cover in detail the particular characteristics of every excipient. How-ever, its use is intended for individuals experienced and competent in the area of auditing who should be diligent inselecting which areas of Good Manufacturing Practice are relevant to a specific particular audit and in determining the ap-propriateness of questions (and the answers provided) based on the characteristics of the excipient manufactured, theprocesses employed, and specific requirements of the excipient user.
FormatThis Audit Guide is provided in two formats, either of which may be used by the auditor based on personal preference:
• Detailed questions arranged in the same sequence as in the GMP Guide. This format is frequently useful as a trainingtool for personnel of both the auditing company and one being audited.
• Short “reminder” phrases arranged in the same sequence as in the GMP Guide, a format which generally is more usefulduring an audit.
Copyright© 2007 The International Pharmaceutical Excipients Council and Copyright© 2007 Pharmaceutical Quality Group
iv
Cop
yrig
ht©
200
7 T
he In
tern
atio
nal P
harm
aceu
tical
Exc
ipie
nts
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ncil
and
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7 P
harm
aceu
tical
Qua
lity
Gro
up
TH
E IN
TE
RN
AT
ION
AL
PH
AR
MA
CE
UT
ICA
L E
XC
IPIE
NT
S C
OU
NC
ILP
HA
RM
AC
EU
TIC
AL
QU
AL
ITY
GR
OU
P
GM
P A
UD
IT G
UID
EFO
R
PH
AR
MA
CEU
TIC
AL
EXC
IPIE
NTS
FO
RM
AT:
DE
TAIL
ED
QU
ES
TIO
NS
IN S
EQ
UE
NC
E
OF
TH
E J
OIN
T G
MP
GU
IDE
IPE
C-P
QG
GM
P A
UD
IT G
UID
E F
OR
PH
AR
MA
CE
UT
ICA
L E
XC
IPIE
NT
S
Cop
yrig
ht©
200
7 T
he In
tern
atio
nal P
harm
aceu
tical
Exc
ipie
nts
Cou
ncil
and
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yrig
ht©
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7 P
harm
aceu
tical
Qua
lity
Gro
up1
4Q
UA
LIT
Y M
AN
AG
EM
EN
T S
YS
TE
M-E
XC
IPIE
NT
QU
AL
ITY
SY
ST
EM
S
4.1
Gen
eral
Req
uir
emen
ts
4.2
Do
cum
enta
tio
n R
equ
irem
ents
4.2.
1G
ener
al
4.2.
2Q
ual
ity
Man
ual
Is th
ere
a Q
ualit
y M
anua
l and
if s
o, w
hat i
s th
e cu
rren
t ver
sion
of i
t? If
not
, is
ther
e a
suita
ble
alte
rnat
ive?
Is th
ere
a Q
ualit
y P
olic
y or
a s
imila
r st
atem
ent o
f the
inte
nt to
mee
t exc
ipie
ntG
MP
req
uire
men
ts?
Has
the
man
ufac
ture
r de
fined
the
poin
t at w
hich
GM
P s
houl
d be
app
lied
and
mai
ntai
ned?
How
is a
com
mitm
ent t
o ap
plyi
ng th
e ap
prop
riate
GM
Ps
expr
esse
d?H
ow d
oes
it ex
plai
n w
hat a
ctiv
ities
are
cov
ered
by
the
GM
Ps
and
wha
t are
not
?
4.2.
3C
on
tro
l of
Do
cum
ents
Is th
ere
a lis
t of S
tand
ard
Ope
ratin
g P
roce
dure
s (S
OP
s) fo
r ar
eas
of th
e op
erat
ion
affe
ctin
g qu
ality
?.D
oes
the
docu
men
t con
trol
sys
tem
cov
er th
e co
mpl
ete
writ
ten
man
ufac
turin
g in
stru
ctio
ns s
uch
as:
•sp
ecify
qua
ntity
and
iden
tity
of r
aw m
ater
ials
, •
equi
pmen
t, •
man
ufac
turin
g flo
w,
•op
erat
ing
para
met
ers,
•
in-p
roce
ss s
ampl
ing,
•
equi
pmen
t cle
anin
g,•
pack
agin
g m
ater
ials
, •
labe
ling,
and
•
docu
men
tatio
n of
eac
h si
gnifi
cant
ste
p?H
ow a
re c
urre
nt S
OP
s m
ade
read
ily a
vaila
ble
to e
mpl
oyee
s? (
oper
atin
g ro
cedu
res,
man
ufac
turin
g in
stru
ctio
ns a
nd te
st m
etho
ds)
Is th
ere
an S
OP
for
writ
ing,
han
dlin
g an
d up
datin
g S
OP
s?W
hat i
s th
e pr
oced
ure
for p
erio
dic
revi
ew o
f SO
Ps?
Doe
s it
incl
ude
upda
te, a
ndap
prov
al b
y re
spon
sibl
e pe
rson
nel a
nd is
trai
ning
per
form
ed a
fter u
pdat
es?
How
is c
onfo
rman
ce to
SO
Ps
verif
ied
and
docu
men
ted?
Wha
t is
the
syst
em to
ass
ure
that
unn
eede
d or
obs
olet
e do
cum
ents
are
re
mov
ed fr
om u
se?
Are
onl
y cu
rren
t ver
sion
s of
the
docu
men
ts b
eing
use
d?
NO
TE
S
Are
doc
umen
ts th
at im
pact
pro
duct
qua
lity
revi
ewed
and
app
rove
d by
the
Qua
lity
Uni
t or
othe
r de
sign
ated
qua
lifie
d pe
rson
nel i
ndep
ende
nt fr
om
prod
uctio
n?H
ow a
re d
ocum
ents
con
trol
led
(ele
ctro
nic
and
pape
r co
pies
)? A
re o
bsol
ete
vers
ions
with
draw
n fr
om u
se?
How
are
they
iden
tifie
d? H
ow a
re o
wne
rs
indi
cate
d?
4.2.
4C
on
tro
l of
Rec
ord
s
Wha
t Is
the
syst
em u
sed
to tr
ack,
con
trol
, and
mai
ntai
n al
l rec
ords
that
rel
ate
to th
e re
quire
men
ts o
f the
Qua
lity
Sys
tem
?H
ow a
re u
npla
nned
pro
cess
cha
nges
(pr
oces
s ex
curs
ions
) do
cum
ente
d?W
here
ele
ctro
nic
sign
atur
es a
re b
eing
use
d, a
re th
ey c
ontr
olle
d to
pro
vide
equi
vale
nt a
ssur
ance
to w
ritte
n si
gnat
ures
?Is
the
reco
rd r
eten
tion
polic
y ju
stifi
ed a
nd w
hat i
s th
e ra
tiona
le?
Is th
is
desc
ribed
in a
writ
ten
reco
rds
rete
ntio
n po
licy?
Is a
cop
y of
the
prod
uct l
abel
ret
aine
d w
ith th
e ba
tch
reco
rd?
Are
the
reco
rds
legi
ble,
inde
lible
, sig
ned,
dat
ed a
nd k
ept i
n a
suita
ble
envi
ronm
ent t
o m
inim
ize
dete
riora
tion
or d
amag
e?
4.3
Ch
ang
e C
on
tro
l
Are
ther
e ad
equa
te w
ritte
n pr
oced
ures
for
a ch
ange
con
trol
sys
tem
for
thos
ech
ange
s th
at m
ay h
ave
an im
pact
on
the
qual
ity o
f the
exc
ipie
nt o
r th
eir
conf
orm
ance
to G
MP
? D
oes
it in
clud
e re
view
and
app
rova
l of c
hang
es to
raw
mat
eria
ls, p
roce
sses
, doc
umen
ts, a
nd e
quip
men
t?D
oes
a un
it in
depe
nden
t fro
m p
rodu
ctio
n (e
.g. t
he Q
ualit
y U
nit o
r R
egul
ator
y A
ffairs
) ha
ve th
e re
spon
sibi
lity
and
auth
ority
for
the
final
app
rova
l of c
hang
es?
If th
e co
mpa
ny p
erfo
rms
qual
ifica
tion
and
valid
atio
n ac
tiviti
es, d
oes
the
chan
ge c
ontr
ol s
yste
m p
ick
up th
e re
quire
men
t to
eval
uate
the
impa
ct o
f ach
ange
on
thes
e re
cord
s?D
oes
the
chan
ge c
ontr
ol s
yste
m r
equi
re c
onsi
dera
tion
for
notif
ying
cus
tom
ers
or r
egul
ator
y au
thor
ities
?H
ow d
oes
the
chan
ge c
ontr
ol s
yste
m li
nk to
any
DM
F o
r C
EP
sub
mis
sion
s?Is
a lo
g m
aint
aine
d of
cha
nges
?
5.M
AN
AG
EM
EN
T R
ES
PO
NS
IBIL
ITY
5.1
Man
agem
ent
Co
mm
itm
ent
How
has
Man
agem
ent d
emon
stra
ted
the
impo
rtan
ce o
f cus
tom
er s
atis
fact
ion
and
com
plia
nce?
Is it
doc
umen
ted
in a
form
al s
tate
men
t suc
h as
a c
orpo
rate
Qua
lity
Pol
icy?
IPE
C-P
QG
GM
P A
UD
IT G
UID
E F
OR
PH
AR
MA
CE
UT
ICA
L E
XC
IPIE
NT
S
NO
TE
S
Cop
yrig
ht©
200
7 T
he In
tern
atio
nal P
harm
aceu
tical
Exc
ipie
nts
Cou
ncil
and
Cop
yrig
ht©
200
7 P
harm
aceu
tical
Qua
lity
Gro
up2
5.2
Cu
sto
mer
Fo
cus
Wha
t is
the
polic
y fo
r ac
com
mod
atin
g cu
stom
er a
udits
of t
he fa
cilit
y?H
ow a
re c
usto
mer
req
uire
men
ts d
eter
min
ed a
nd tr
ansl
ated
into
the
qual
ity
man
agem
ent s
yste
m?
5.3
Qu
alit
y P
olic
y
Wha
t evi
denc
e is
ther
e th
at a
ll pe
rson
nel a
re a
war
e of
the
polic
y?D
oes
the
polic
y su
ppor
t con
tinua
l im
prov
emen
t of t
he q
ualit
y m
anag
emen
t sys
tem
?
5.4
Pla
nn
ing
5.4.
1 Q
ual
ity
Ob
ject
ives
Wha
t mea
sura
ble
obje
ctiv
es h
ave
been
est
ablis
hed
for
conf
orm
ance
to th
e Q
ualit
y S
yste
m a
nd G
MP
req
uire
men
ts?
5.4.
2 Q
ual
ity
Man
agem
ent
Sys
tem
Pla
nn
ing
Wha
t pro
cess
is th
ere
for
iden
tific
atio
n of
ade
quat
e re
sour
ces
need
ed fo
r ad
here
nce
to G
MP
?Is
ther
e an
y ob
serv
able
evi
denc
e th
at a
dequ
ate
reso
urce
s ha
ve n
ot b
een
prov
ided
?
5.5
Res
po
nsi
bili
ty, A
uth
ori
ty a
nd
Co
mm
un
icat
ion
5.5.
1R
esp
on
sib
ility
an
d A
uth
ori
ty
Wha
t mea
ns a
re u
sed
to s
how
the
inde
pend
ent r
epor
ting
rela
tions
hip
betw
een
the
Qua
lity
Uni
t and
Pro
duct
ion?
Are
ther
e or
gani
zatio
n ch
arts
?A
re th
ere
clea
rly w
ritte
n jo
b de
scrip
tions
?W
here
are
the
Qua
lity
Uni
t’s a
utho
rity
and
resp
onsi
bilit
ies
clea
rly d
efin
ed in
w
ritin
g?W
hat d
ocum
enta
tion
supp
orts
the
Qua
lity
Uni
t’s in
depe
nden
t aut
horit
y to
ap
prov
e or
rej
ect p
roce
dure
s, s
peci
ficat
ions
, and
pro
cess
cha
nges
that
po
tent
ially
impa
ct p
rodu
ct q
ualit
y?W
hat d
ocum
enta
tion
show
s th
e Q
ualit
y U
nit h
as in
depe
nden
t aut
horit
y to
re
ject
raw
mat
eria
ls, p
acka
ging
com
pone
nts
and
finis
hed
prod
uct b
atch
es?
Wha
t con
trol
s ar
e in
pla
ce fo
r th
e re
spon
sibi
litie
s of
the
Qua
lity
Uni
t tha
t hav
ebe
en d
eleg
ated
to o
ther
per
sonn
el?
Wha
t rol
e do
es th
e Q
ualit
y U
nit p
lay
in in
vest
igat
ing
devi
atio
ns, f
ailu
res
and
com
plai
nts?
How
doe
s th
e Q
ualit
y U
nit d
ocum
ent t
heir
appr
oval
or
reje
ctio
n of
new
sup
pli-
ers
of q
ualit
y cr
itica
l mat
eria
ls a
nd s
ervi
ces?
IPE
C-P
QG
GM
P A
UD
IT G
UID
E F
OR
PH
AR
MA
CE
UT
ICA
L E
XC
IPIE
NT
S
NO
TE
S
Cop
yrig
ht©
200
7 T
he In
tern
atio
nal P
harm
aceu
tical
Exc
ipie
nts
Cou
ncil
and
Cop
yrig
ht©
200
7 P
harm
aceu
tical
Qua
lity
Gro
up3
How
doe
s th
e Q
ualit
y U
nit a
chie
ve th
eir
resp
onsi
bilit
y fo
r th
e re
view
of
appr
opria
te m
anuf
actu
ring
docu
men
tatio
n an
d ba
tch
disp
ositi
on d
ecis
ions
?
5.5.
2M
anag
emen
t R
epre
sen
tati
ve
How
ofte
n do
es th
e m
anag
emen
t rep
rese
ntat
ive
repo
rt o
n th
e co
nfor
man
ce o
fth
e Q
ualit
y S
yste
m to
top
man
agem
ent?
5.5.
3In
tern
al C
om
mu
nic
atio
n
How
are
GM
P a
nd r
egul
ator
y re
quire
men
ts, q
ualit
y po
licie
s, q
ualit
y ob
ject
ives
and
proc
edur
es c
omm
unic
ated
thro
ugho
ut th
e or
gani
zatio
n?H
ow is
top
man
agem
ent i
nfor
med
of q
ualit
y cr
itica
l situ
atio
ns?
5.6
Man
agem
ent
Rev
iew
5.6.
1G
ener
al
Doe
s to
p m
anag
emen
t hol
d pe
riodi
c re
view
s to
con
firm
con
tinue
d co
nfor
man
ce to
the
Qua
lity
Man
agem
ent S
yste
m?
How
is to
p m
anag
emen
t inv
olve
men
t dem
onst
rate
d?H
ow a
re th
e op
port
uniti
es fo
r im
prov
emen
t and
the
need
for
chan
ges
capt
ured
, rev
iew
ed, i
mpl
emen
ted
and
reco
rded
?”
5.6.
2R
evie
w In
pu
t
Doe
s th
e m
anag
emen
t rev
iew
inpu
t inc
lude
, for
exa
mpl
e, a
udit
resu
lts,
cust
omer
com
plai
nts
and
feed
back
, pro
duct
con
form
ity, p
roce
ss p
erfo
rman
ce,
stat
us o
f cor
rect
ive
and
prev
entiv
e ac
tions
and
rel
evan
t reg
ulat
ory
/ leg
isla
tion
chan
ges?
5.6.
3R
evie
w O
utp
ut
Doe
s th
e re
view
out
put a
ddre
ss r
esou
rces
nee
ded
for
impr
ovem
ent o
f the
qual
ity m
anag
emen
t sys
tem
and
def
ine
actio
ns to
be
take
n?
6 R
ES
OU
RC
E M
AN
AG
EM
EN
T
6.1
Pro
visi
on
of
Res
ou
rces
Doe
s th
ere
appe
ar to
be
adeq
uate
res
ourc
es to
per
form
and
sup
ervi
se th
e op
erat
ions
nec
essa
ry fo
r pr
oduc
ing,
pac
kagi
ng, t
estin
g, s
torin
g an
d re
leas
ing
exci
pien
ts in
com
plia
nce
with
app
licab
le G
MP
req
uire
men
ts?
6.2
Hu
man
Res
ou
rces
6.2.
1G
ener
al
How
are
qua
lific
atio
ns (
trai
ning
, exp
erie
nce,
and
edu
catio
n) d
ocum
ente
d an
dre
late
d to
the
assi
gned
task
s?
IPE
C-P
QG
GM
P A
UD
IT G
UID
E F
OR
PH
AR
MA
CE
UT
ICA
L E
XC
IPIE
NT
S
NO
TE
S
Cop
yrig
ht©
200
7 T
he In
tern
atio
nal P
harm
aceu
tical
Exc
ipie
nts
Cou
ncil
and
Cop
yrig
ht©
200
7 P
harm
aceu
tical
Qua
lity
Gro
up4
If us
ed, w
ho r
evie
ws
the
qual
ifica
tions
of c
onsu
ltant
s to
ass
ure
they
hav
e su
ffici
ent e
duca
tion,
trai
ning
, and
exp
erie
nce
to a
dvis
e on
the
subj
ect f
orw
hich
they
are
ret
aine
d?A
re c
onsu
ltant
s an
d co
ntra
ctor
s ap
prop
riate
ly tr
aine
d be
fore
bei
ng a
llow
edin
to th
e fa
cilit
y?
6.2.
2C
om
pet
ence
, Aw
aren
ess
and
Tra
inin
g
Is th
ere
a S
OP
for
iden
tifyi
ng tr
aini
ng n
eeds
and
pro
vidi
ng th
e ne
cess
ary
trai
ning
on
a re
gula
r ba
sis?
Wha
t are
the
qual
ifica
tions
for
indi
vidu
als
perfo
rmin
g G
MP
trai
ning
?A
re jo
b-sp
ecifi
c tr
aini
ng r
equi
rem
ents
cle
arly
def
ined
?H
ow d
oes
the
train
ing
prog
ram
ens
ure
that
per
sonn
el u
nder
stan
d th
at d
evia
tions
from
pro
cedu
res
may
hav
e an
impa
ct o
n th
e cu
stom
er’s
pro
duct
qua
lity?
Is th
ere
pers
onal
hyg
iene
trai
ning
for
pers
onne
l han
dlin
g pr
oduc
t so
they
un
ders
tand
the
prec
autio
ns n
eces
sary
to p
reve
nt th
e co
ntam
inat
ion
of th
e ex
cipi
ent?
How
is it
doc
umen
ted?
Wha
t rec
ords
are
kep
t to
dem
onst
rate
that
GM
P tr
aini
ng is
con
duct
ed in
atim
ely
man
ner
for
new
and
tem
pora
ry e
mpl
oyee
s as
wel
l as
cons
ulta
nts
and
cont
ract
ors?
Wha
t is
the
freq
uenc
y of
con
tinui
ng G
MP
trai
ning
and
is it
suf
ficie
nt to
ens
ure
that
em
ploy
ees
rem
ain
fam
iliar
with
app
licab
le G
MP
req
uire
men
ts?
How
broa
dly
is th
e tr
aini
ng c
ondu
cted
with
in th
e si
te?
How
are
trai
ning
effe
ctiv
enes
s an
d em
ploy
ee c
ompe
tenc
y as
sess
ed?
H
ow is
trai
ning
and
qua
lific
atio
ns d
ocum
ente
d fo
r ea
ch e
mpl
oyee
?H
ow a
re c
hang
es in
reg
ulat
ory
requ
irem
ents
mon
itore
d, in
terp
rete
d, a
nd
com
mun
icat
ed to
em
ploy
ees?
6.2.
3 P
erso
nn
el H
ygie
ne
How
are
per
sonn
el h
ygie
ne r
equi
rem
ents
and
pro
tect
ive
equi
pmen
t spe
cifie
dan
d co
mm
unic
ated
to e
mpl
oyee
s?A
re p
erso
nnel
obs
erve
d to
com
ply
with
requ
irem
ents
for c
lean
lines
s, s
peci
alcl
othi
ng, p
rote
ctio
n, a
nd h
air c
over
ings
as
requ
ired
in th
e va
rious
man
ufac
turin
g,pa
ckag
ing
and
test
ing
area
s? Is
ther
e ap
prop
riate
sig
nage
for s
uch
requ
irem
ents
?A
re p
erso
nnel
req
uire
d to
rep
ort a
ny h
ealth
con
ditio
ns th
at m
ay h
ave
an
adve
rse
effe
ct o
n th
e pr
oduc
t?
IPE
C-P
QG
GM
P A
UD
IT G
UID
E F
OR
PH
AR
MA
CE
UT
ICA
L E
XC
IPIE
NT
S
NO
TE
S
Cop
yrig
ht©
200
7 T
he In
tern
atio
nal P
harm
aceu
tical
Exc
ipie
nts
Cou
ncil
and
Cop
yrig
ht©
200
7 P
harm
aceu
tical
Qua
lity
Gro
up5
Are
per
sonn
el w
ith il
lnes
s or
ope
n sk
in le
sion
s th
at m
ay c
onta
min
ate
or
othe
rwis
e ad
vers
ely
affe
ct th
e sa
fety
or
qual
ity o
f the
pro
duct
allo
wed
to w
ork
in a
ny o
pera
tion
that
cou
ld c
ause
the
prod
uct t
o be
com
e co
ntam
inat
ed?
Is th
ere
a po
licy
proh
ibiti
ng lo
ose
and/
or u
nsec
ured
jew
elry
or
othe
r ite
ms
inop
erat
ions
whe
re th
ey c
an fa
ll in
to th
e pr
oduc
t? A
re p
erso
nnel
obs
erve
d to
be
in c
ompl
ianc
e?W
here
can
lab
and
oper
atin
g pe
rson
nel s
tore
and
con
sum
e fo
od, b
ever
age,
or to
bacc
o pr
oduc
ts?
Are
thes
e no
n-pr
oduc
tion/
lab
area
s de
sign
ated
?W
hat m
easu
res
with
in th
e fa
cilit
y ha
ve b
een
take
n to
pre
vent
una
utho
rized
and
unes
cort
ed a
cces
s to
crit
ical
pro
cess
ing
oper
atio
ns a
nd o
ther
sen
sitiv
ear
eas?
6.3
Infr
astr
uct
ure
6.3.
1B
uild
ing
s an
d F
acili
ties
Are
ther
e ad
equa
te s
pace
and
env
ironm
enta
l con
trol
s to
ens
ure
prod
uct
inte
grity
and
to p
recl
ude
mix
-ups
or
cros
s-co
ntam
inat
ion,
esp
ecia
lly in
dry
ing,
mill
ing,
ble
ndin
g, p
acka
ging
and
war
ehou
sing
ope
ratio
ns?
Whe
re th
e ex
cipi
ent i
s ex
pose
d, a
re th
ere
adeq
uate
mea
sure
s to
pre
vent
co
ntam
inat
ion,
incl
udin
g m
icro
bial
?W
hat o
ther
mat
eria
ls a
re p
rodu
ced
or s
tore
d in
clo
se p
roxi
mity
to e
xcip
ient
prod
uctio
n or
whe
re it
is e
xpos
ed to
the
envi
ronm
ent?
Doe
s th
e fa
cilit
y us
e or
prod
uce
high
ly s
ensi
tizin
g or
toxi
c su
bsta
nces
? If
so, w
hat c
ontr
ols
are
used
to p
reve
nt c
onta
min
atio
n of
the
exci
pien
t? W
hat e
vide
nce
is th
ere
that
thes
em
easu
res
are
effe
ctiv
e?A
re fa
cilit
ies
mai
ntai
ned
in a
goo
d st
ate
of r
epai
r?A
re th
ere
adeq
uate
labo
rato
ry fa
cilit
ies
to p
erfo
rm r
equi
red
test
ing?
Is th
ere
adeq
uate
spa
ce a
roun
d fin
ishe
d ex
cipi
ent l
ocat
ions
in th
e w
areh
ouse
to fa
cilit
ate
clea
ning
?
6.3.
2E
qu
ipm
ent
How
is e
quip
men
t com
mis
sion
ed p
rior
to in
itial
use
?Is
equ
ipm
ent m
aint
aine
d in
a g
ood
stat
e of
rep
air?
If
proc
essi
ng o
ccur
s ou
tdoo
rs w
hat c
ontr
ols
are
in p
lace
to m
inim
ize
risk
to
exci
pien
t qua
lity?
6.3.
2.1
Eq
uip
men
t Co
nst
ruct
ion
Is e
quip
men
t con
stru
cted
so
that
pro
duct
-con
tact
sur
face
s ar
e no
t rea
c-tiv
e, a
dditi
ve, o
r abs
orpt
ive
and
will
not
adv
erse
ly a
ffect
the
prod
uct?
IPE
C-P
QG
GM
P A
UD
IT G
UID
E F
OR
PH
AR
MA
CE
UT
ICA
L E
XC
IPIE
NT
S
NO
TE
S
Cop
yrig
ht©
200
7 T
he In
tern
atio
nal P
harm
aceu
tical
Exc
ipie
nts
Cou
ncil
and
Cop
yrig
ht©
200
7 P
harm
aceu
tical
Qua
lity
Gro
up6
Is e
quip
men
t des
igne
d an
d us
ed in
a m
anne
r th
at m
inim
izes
the
pote
ntia
l for
con
tam
inat
ion
of p
rodu
ct w
ith lu
bric
ants
, coo
lant
s, m
etal
or s
eal f
ragm
ents
, or
othe
r ex
tran
eous
mat
eria
ls?
If pr
oduc
t exp
osur
e to
, or
cont
amin
atio
n w
ith, l
ubric
ants
or
cool
ants
ispo
ssib
le, a
re th
ese
mat
eria
ls s
uita
ble
for
use
in fo
od a
pplic
atio
ns?
Wha
t pro
visi
ons
are
mad
e fo
r m
onito
ring
the
prod
uct f
or m
etal
co
ntam
inat
ion
whe
re a
ppro
pria
te?
How
is th
e eq
uipm
ent d
esig
ned,
whe
re n
eces
sary
, to
min
imiz
e th
epo
ssib
ility
of c
onta
min
atio
n fr
om o
pera
tor
cont
act i
n op
erat
ions
suc
has
unl
oadi
ng o
f cen
trifu
ge b
ags,
use
of t
rans
fer
hose
s, a
nd o
pera
tion
of d
ryin
g eq
uipm
ent a
nd p
umps
?
6.3.
2.2
Eq
uip
men
t Mai
nte
nan
ce
Is th
ere
a sy
stem
for
clea
ning
, ins
pect
ing
and
appr
ovin
g eq
uipm
ent
for
use
in m
anuf
actu
ring
afte
r m
aint
enan
ce a
nd r
epai
rs h
ave
been
perfo
rmed
?A
re th
ere
SO
Ps
and
appr
opria
te d
ocum
enta
tion
for i
nspe
ctio
n (m
onito
ring
the
cond
ition
) and
mai
nten
ance
of e
quip
men
t and
for
mea
surin
g an
d te
st in
stru
men
ts?
Do
the
SO
Ps
assi
gn re
spon
sibi
litie
s;in
clud
e sc
hedu
les;
des
crib
e m
etho
ds, a
nd e
quip
men
t, an
d m
ater
ials
to
be
used
?A
re r
ecor
ds k
ept o
f pre
vent
ive
mai
nten
ance
, rep
airs
, and
use
?
6.3.
2.3
Co
mp
ute
r S
yste
ms
If co
mpu
teriz
ed s
yste
ms
are
used
in a
man
ner
that
can
impa
ct
exci
pien
t qua
lity,
hav
e th
ey b
een
dem
onst
rate
d to
con
sist
ently
fu
nctio
n as
exp
ecte
d?
Wha
t pro
cess
is u
sed
to c
ontro
l cha
nges
to s
yste
ms
and
prog
ram
s th
atca
n ha
ve a
n ef
fect
on
the
qual
ity o
f the
pro
duct
(see
4.3
), to
ass
ure
that
chan
ges
rece
ive
the
prop
er re
view
and
app
rova
l with
rega
rd to
pot
entia
lef
fect
s be
fore
bei
ng in
stitu
ted
and
that
onl
y au
thor
ized
per
sonn
el c
anm
ake
such
cha
nges
? A
re p
erso
nnel
trai
ned
subs
eque
nt to
cha
nges
?H
ow is
acc
ess
to c
ompu
teriz
ed s
yste
ms
limite
d in
ord
er to
pro
tect
reco
rds
from
tam
perin
g, a
nd p
reve
nt d
ata
alte
ratio
n?If
pass
wor
ds a
re u
sed
as a
sec
urity
mea
sure
, are
ther
e pr
ovis
ions
for
perio
dic
chan
ging
of p
assw
ords
? A
re th
ere
desi
gnee
s fo
r al
l crit
ical
syst
em o
pera
tions
and
em
erge
ncie
s?
IPE
C-P
QG
GM
P A
UD
IT G
UID
E F
OR
PH
AR
MA
CE
UT
ICA
L E
XC
IPIE
NT
S
NO
TE
S
Cop
yrig
ht©
200
7 T
he In
tern
atio
nal P
harm
aceu
tical
Exc
ipie
nts
Cou
ncil
and
Cop
yrig
ht©
200
7 P
harm
aceu
tical
Qua
lity
Gro
up7
Wha
t is
the
proc
edur
e fo
r rev
iew
ing
and
upda
ting
secu
rity
acce
ss w
hen
a pe
rson
leav
es th
e de
part
men
t or c
ompa
ny?
Is th
eir a
cces
s to
the
syst
em o
r the
ir ac
cess
cod
es to
the
syst
em re
voke
d in
a ti
mel
y fa
shio
n?W
hat b
acku
p sy
stem
s ar
e in
pla
ce, s
uch
as c
opie
s of
pro
gram
s an
dfil
es, d
uplic
ate
tape
s, o
r m
icro
film
, and
has
ret
rieva
bilit
y of
info
rmat
ion
from
mas
ter
tape
s an
d ba
ckup
tape
s be
en v
erifi
ed?
Are
ther
e pr
oced
ures
in p
lace
for
disa
ster
rec
over
y, in
the
even
t of a
pow
er
outa
ge, l
oss
of s
erve
r an
d co
mpu
teriz
ed s
yste
ms
etc?
6.3.
3U
tilit
ies
Wha
t util
ities
are
use
d in
the
prod
uctio
n, s
tora
ge o
r tr
ansf
er o
f mat
eria
ls th
atco
uld
impa
ct e
xcip
ient
qua
lity?
How
hav
e th
ese
utili
ties
been
ass
esse
d an
dap
prop
riate
act
ion
take
n to
ass
ure
they
do
not c
onta
min
ate
the
exci
pien
t?
6.3.
4W
ater
If w
ater
is u
sed
in th
e m
anuf
actu
re o
f the
exc
ipie
nt, w
hat i
s its
sou
rce
and
is it
suita
ble
for
its in
tend
ed u
se?
If w
ater
is u
sed
whe
re it
cou
ld c
onta
min
ate
the
exci
pien
t, do
es p
roce
ss w
ater
at a
min
imum
mee
t WH
O g
uide
lines
for
drin
king
(po
tabl
e) w
ater
qua
lity?
Isth
ere
an in
tern
al w
ritte
n sp
ecifi
catio
n fo
r pr
oces
s w
ater
?W
here
wat
er c
an im
pact
exc
ipie
nt q
ualit
y:•
How
is p
roce
ss w
ater
per
iodi
cally
mon
itore
d fo
r ch
emic
al a
nd m
icro
bial
qual
ity?
•Is
the
proc
ess
wat
er s
uppl
ied
unde
r co
ntin
uous
pos
itive
pre
ssur
e or
are
othe
r m
eans
use
d to
pre
vent
bac
k flo
w?
•W
here
the
wat
er is
pur
ified
on-
site
, are
ther
e ch
emic
al a
nd m
icro
bial
qua
lity
stan
dard
s an
d ac
tion
limits
for
such
wat
er, w
ith a
n es
tabl
ishe
d m
onito
ring
prog
ram
?•
Whe
re th
e w
ater
is p
urifi
ed, i
s th
e pu
rific
atio
n sy
stem
per
iodi
cally
san
itize
dan
d ap
prop
riate
ly m
aint
aine
d?•
If ch
emic
al o
r m
icro
bial
act
ion
limits
for
proc
ess
or p
urifi
ed w
ater
are
ex
ceed
ed, h
ow is
the
caus
e in
vest
igat
ed, t
he p
robl
em c
orre
cted
, the
impa
ctof
the
cont
amin
atio
n of
pro
duct
s m
anuf
actu
red
with
the
wat
er a
sses
sed,
and
the
resu
lts o
f the
inve
stig
atio
n do
cum
ente
d?
6.4
Wo
rk E
nvir
on
men
t
Are
exp
osed
mat
eria
ls p
rote
cted
from
ove
rhea
d co
ntam
inat
ion?
A
re p
rodu
ctio
n ar
eas
that
pre
sent
pot
entia
l for
con
tam
inat
ion
prop
erly
con
trol
led
and
equi
pped
with
exh
aust
or
othe
r ap
prop
riate
sys
tem
s?
IPE
C-P
QG
GM
P A
UD
IT G
UID
E F
OR
PH
AR
MA
CE
UT
ICA
L E
XC
IPIE
NT
S
NO
TE
S
Cop
yrig
ht©
200
7 T
he In
tern
atio
nal P
harm
aceu
tical
Exc
ipie
nts
Cou
ncil
and
Cop
yrig
ht©
200
7 P
harm
aceu
tical
Qua
lity
Gro
up8
6.4.
1A
ir H
and
ling
Has
the
effe
ctiv
enes
s of
air
hand
ling
syst
ems
used
to p
rote
ct th
e ex
cipi
ent
been
dem
onst
rate
d to
pro
vide
suc
h pr
otec
tion?
If ai
r is
rec
ircul
ated
to a
reas
whe
re p
rodu
ct is
exp
osed
, is
it fil
tere
d an
d co
ntro
lled
to e
limin
ate
cros
s-co
ntam
inat
ion?
Are
suc
h fil
ters
per
iodi
cally
chec
ked
and
repl
aced
and
whe
re is
this
doc
umen
ted?
6.4.
2C
on
tro
lled
Env
iro
nm
ent
Is th
e m
anuf
actu
ring
envi
ronm
ent a
ppro
pria
tely
con
trol
led
for
the
proc
ess
taki
ng p
lace
to p
rote
ct th
e ex
cipi
ent a
gain
st d
eter
iora
tion
and
cont
amin
atio
n?H
ow is
it m
onito
red?
If a
spec
ial e
nviro
nmen
t is
requ
ired,
is it
con
tinuo
usly
mon
itore
d?In
the
even
t of a
n in
terr
uptio
n to
the
spec
ial e
nviro
nmen
t, is
the
impa
ct u
pon
the
qual
ity o
f the
exc
ipie
nt e
valu
ated
and
doc
umen
ted?
6.4.
3C
lean
ing
an
d S
anit
ary
Co
nd
itio
ns
Are
faci
litie
s m
aint
aine
d in
an
appr
opria
tely
cle
an, s
anita
ry a
nd o
rder
ly
man
ner?
Whe
re e
xcip
ient
qua
lity
can
be a
dver
sely
impa
cted
, are
ther
e ad
equa
tely
de
taile
d S
OP
s fo
r sa
nita
tion
and
clea
ning
? H
ow is
com
plia
nce
mon
itore
d an
d do
cum
ente
d? D
o th
e S
OP
s as
sign
res
pons
ibili
ties;
incl
ude
sche
dule
s;
desc
ribe
met
hods
, equ
ipm
ent,
and
mat
eria
ls to
be
used
; and
req
uire
m
aint
enan
ce o
f rec
ords
?H
ow is
was
te s
egre
gate
d an
d st
orag
e co
ntai
ners
iden
tifie
d? W
hat i
s th
e fr
eque
ncy
of d
ispo
sal?
Has
the
man
ufac
turin
g en
viro
nmen
t bee
n ev
alua
ted
for
the
pote
ntia
l for
co
ntam
inat
ion
by p
hysi
cal o
r ch
emic
al m
ater
ials
or
by m
icro
bes
in th
e ar
ea?
6.4.
4P
est
Co
ntr
ol
Whe
re n
eces
sary
, is
ther
e a
prog
ram
to p
rote
ct q
ualit
y cr
itica
l mat
eria
ls
and
prod
uct f
rom
con
tam
inat
ion
due
to in
sect
s, r
oden
ts, b
irds,
and
oth
er
verm
in (
incl
udin
g do
mes
tic a
nim
als)
? W
hat e
vide
nce
is th
ere
to s
how
that
it
is a
dequ
ate?
Whe
re n
eces
sary
, how
are
win
dow
s, d
oors
, or
othe
r op
enin
gs to
the
outs
ide
adeq
uate
ly p
rote
cted
from
ent
ry b
y pe
sts?
If r
aw m
ater
ials
or
inte
rmed
iate
sar
e st
ored
in s
ilos,
tank
s, o
r ot
her
larg
e co
ntai
ners
, how
are
the
vent
s ad
equa
tely
pro
tect
ed to
pre
vent
ent
ry o
f bird
s an
d in
sect
s?If
used
, are
rod
entic
ides
, her
bici
des
and
pest
icid
es a
ppro
pria
tely
eva
luat
ed?
IPE
C-P
QG
GM
P A
UD
IT G
UID
E F
OR
PH
AR
MA
CE
UT
ICA
L E
XC
IPIE
NT
S
NO
TE
S
Cop
yrig
ht©
200
7 T
he In
tern
atio
nal P
harm
aceu
tical
Exc
ipie
nts
Cou
ncil
and
Cop
yrig
ht©
200
7 P
harm
aceu
tical
Qua
lity
Gro
up9
If an
out
side
par
ty p
erfo
rms
pest
con
trol
, how
is th
at p
arty
’s p
erfo
rman
ce a
ndco
mpl
ianc
e m
onito
red?
Doe
s th
e pa
rty
use
a si
te m
ap a
nd is
sue
a re
port
? Is
the
repo
rt r
evie
wed
by
the
man
ufac
ture
r?A
re p
est c
ontr
ol r
ecor
ds k
ept?
Wha
t cor
rect
ive
and
prev
entiv
e m
easu
res
have
been
take
n?If
the
natu
re o
f raw
mat
eria
l (su
ch a
s bo
tani
cals
) re
sults
in u
navo
idab
le
cont
amin
atio
n, w
hat a
re th
e co
ntro
ls to
pre
vent
the
incr
ease
or
spre
ad in
co
ntam
inat
ion
or in
fest
atio
n?
6.4.
5L
igh
tin
g
Is th
ere
adeq
uate
ligh
ting?
Is th
e lig
htin
g pr
otec
ted
from
sha
tterin
g in
are
as w
here
the
prod
uct m
ay b
e ex
pose
d?
6.4.
6D
rain
age
Whe
re th
e ex
cipi
ent i
s op
en to
the
envi
ronm
ent,
are
drai
ns o
f ade
quat
e si
ze?
Are
they
equ
ippe
d w
ith a
n ai
r br
eak
or o
ther
mec
hani
sm to
pre
vent
bac
k flo
w?
Is th
e pl
umbi
ng s
yste
m fr
ee o
f def
ects
that
cou
ld c
ause
con
tam
inat
ion
of th
eex
cipi
ent?
6.4.
7W
ash
ing
an
d T
oile
t Fa
cilit
ies
Are
ther
e ad
equa
te h
and
was
hing
, dry
ing
and
sani
tizin
g fa
cilit
ies
at a
ppro
pria
telo
catio
ns in
the
plan
t? A
re a
ll in
goo
d re
pair?
Do
they
pro
vide
hot
and
col
dw
ater
, soa
p or
det
erge
nt, a
nd h
ave
air d
ryer
s or
sin
gle
serv
ice
tow
els?
Are
ther
e cl
ean,
rea
dily
acc
essi
ble
toile
t fac
ilitie
s th
at a
re m
aint
aine
d in
go
od r
epai
r?A
re th
ere
faci
litie
s fo
r sh
ower
ing
and/
or c
hang
ing
clot
hes?
7.P
RO
DU
CT
RE
AL
IZA
TIO
N
7.1
Pla
nn
ing
of
Pro
du
ct R
ealiz
atio
n
Is a
pro
cess
flow
dia
gram
or
othe
r su
itabl
e de
scrip
tion
of th
e pr
oces
s st
eps
avai
labl
e fo
r th
e au
dite
d pr
oduc
ts?
Is th
e un
it op
erat
ion
batc
h or
con
tinuo
us o
r so
me
com
bina
tion
of th
e tw
o?Is
the
exci
pien
t pro
duce
d in
equ
ipm
ent d
edic
ated
to it
s m
anuf
actu
re o
r is
the
equi
pmen
t als
o us
ed fo
r ot
her
prod
ucts
?
IPE
C-P
QG
GM
P A
UD
IT G
UID
E F
OR
PH
AR
MA
CE
UT
ICA
L E
XC
IPIE
NT
S
NO
TE
S
Cop
yrig
ht©
200
7 T
he In
tern
atio
nal P
harm
aceu
tical
Exc
ipie
nts
Cou
ncil
and
Cop
yrig
ht©
200
7 P
harm
aceu
tical
Qua
lity
Gro
up10
Has
the
proc
ess
been
fully
des
crib
ed r
egar
ding
:•
reac
tions
, •
purif
icat
ions
, •
criti
cal s
teps
, •
oper
atin
g pa
ram
eter
s,
•pr
oces
s lim
itatio
ns,
•im
purit
ies,
and
•
key
test
s ne
eded
for
proc
ess
cont
rol
•pr
oduc
t spe
cific
atio
ns•
sam
plin
g pl
ans
•te
st a
nd r
elea
se p
roce
dure
s?H
ave
proc
ess
para
met
ers
criti
cal t
o qu
ality
bee
n de
fined
, and
if p
aram
eter
s ar
e ex
ceed
ed, i
s th
e af
fect
on
qual
ity k
now
n?Is
ther
e a
syst
em fo
r id
entif
ying
maj
or e
quip
men
t, in
stru
men
ts, a
nd p
rodu
ctio
nlin
es?
Is th
is in
form
atio
n in
clud
ed in
bat
ch p
rodu
ctio
n an
d co
ntro
l rec
ords
whe
reap
prop
riate
?
7.2
Cu
sto
mer
-Rel
ated
Pro
cess
es
7.2.
1D
eter
min
atio
n o
f R
equ
irem
ents
Rel
ated
to
th
e P
rod
uct
Is th
ere
a sy
stem
to d
eter
min
e cu
stom
er r
equi
rem
ents
rel
ated
to th
e pr
oduc
tan
d su
pply
of t
he p
rodu
ct?
How
doe
s th
e m
anuf
actu
rer
com
mun
icat
e th
e ag
reed
cus
tom
er r
equi
rem
ents
to th
e ap
prop
riate
per
sonn
el?
7.2.
2 R
evie
w o
f R
equ
irem
ents
Rel
ated
to
th
e P
rod
uct
Is th
ere
a pr
oced
ure
in p
lace
to a
ssur
e th
at th
e m
anuf
actu
rer
and
the
cust
omer
hav
e m
utua
lly a
gree
d up
on th
e sp
ecifi
catio
ns a
nd o
ther
re
quire
men
ts?
If no
t, w
hat i
s th
e al
tern
ativ
e pr
oces
s?
7.2.
3 C
ust
om
er C
om
mu
nic
atio
n
Is th
ere
a sy
stem
to a
ssur
e th
at a
ny m
utua
lly a
gree
d cu
stom
er-in
itiat
edch
ange
s ar
e pr
ompt
ly in
corp
orat
ed?
Is th
ere
an a
dequ
ate
syst
em in
pla
ce to
ass
ure
that
sig
nific
ant p
roce
ssch
ange
s, in
clud
ing
the
use
of s
ubco
ntra
ctor
s, a
nd th
eir
effe
ct o
n th
e ex
cipi
ent
are
com
mun
icat
ed to
the
cust
omer
?
7.3
Des
ign
an
d D
evel
op
men
t
How
are
des
ign
and
deve
lopm
ent a
ctiv
ities
tran
slat
ed in
to p
lans
for
man
ufac
turin
g?
IPE
C-P
QG
GM
P A
UD
IT G
UID
E F
OR
PH
AR
MA
CE
UT
ICA
L E
XC
IPIE
NT
S
NO
TE
S
Cop
yrig
ht©
200
7 T
he In
tern
atio
nal P
harm
aceu
tical
Exc
ipie
nts
Cou
ncil
and
Cop
yrig
ht©
200
7 P
harm
aceu
tical
Qua
lity
Gro
up11
7.4
Pu
rch
asin
g
7.4.
1P
urc
has
ing
Pro
cess
Wha
t is
the
prog
ram
to q
ualif
y or
dis
qual
ify s
uppl
iers
of r
aw m
ater
ials
, pa
ckag
ing
com
pone
nts
and
serv
ices
that
mig
ht a
ffect
qua
lity,
and
to v
erify
th
at th
ey h
ave
capa
bilit
y to
con
sist
ently
mee
t agr
eed-
upon
req
uire
men
ts?
Doe
s th
is p
rogr
am in
clud
e pe
riodi
c au
dits
by
qual
ified
aud
itors
(or
oth
er
verif
icat
ion
tech
niqu
es)
of s
uppl
iers
whe
n de
emed
nec
essa
ry?
Wha
t is
the
prog
ram
for
the
eval
uatio
n an
d ap
prov
al o
f sub
cont
ract
ors?
Doe
s th
is p
rogr
am in
clud
e pe
riodi
c au
dits
of s
ubco
ntra
ctor
s?W
hat s
yste
m is
in p
lace
to fo
llow
up
on c
orre
ctiv
e ac
tions
for
audi
t fin
ding
s fo
r su
pplie
rs a
nd s
ubco
ntra
ctor
s?A
re m
ater
ials
pur
chas
ed a
gain
st a
n ag
reed
spe
cific
atio
n? H
ow is
it e
nsur
edth
at m
ater
ials
are
onl
y pu
rcha
sed
from
app
rove
d su
pplie
rs?
Are
mat
eria
ls p
urch
ased
that
mig
ht r
esul
t in
the
exci
pien
t bei
ng a
t ris
k w
ith
rega
rd to
BS
E/T
SE
, alle
rgen
s, G
MO
etc
?
7.4.
2 P
urc
has
ing
Info
rmat
ion
Hav
e th
e sp
ecifi
catio
ns, w
hich
wer
e ap
prov
ed b
y th
e Q
ualit
y U
nit o
r th
eir
desi
gnee
, for
the
raw
mat
eria
l or
pack
agin
g co
mpo
nent
bee
n pr
ovid
ed to
the
supp
lier
for
revi
ew a
nd c
oncu
rren
ce?
Wha
t sys
tem
is in
pla
ce to
ass
ure
that
revi
sion
s to
the
spec
ifica
tions
are
pro
vide
d on
a ti
mel
y ba
sis
to th
e su
pplie
r?W
hat s
yste
m is
in p
lace
to a
ssur
e th
at s
uppl
iers
and
sub
cont
ract
ors
notif
y th
eco
mpa
ny o
f sig
nific
ant c
hang
es?
How
are
rel
evan
t con
trac
t man
ufac
ture
rs a
nd la
bora
torie
s no
tifie
d of
the
requ
irem
ent t
o ad
here
to a
ppro
pria
te s
ectio
ns o
f the
Gui
de?
7.4.
3V
erif
icat
ion
of
Pu
rch
ased
Pro
du
ct
Are
pro
cedu
res
in p
lace
cov
erin
g th
e m
eans
to q
uara
ntin
e qu
ality
crit
ical
m
ater
ials
on
rece
ipt u
ntil
they
hav
e be
en a
ppro
ved?
Is s
ampl
ing
for
rele
ase
perfo
rmed
acc
ordi
ng to
a p
lan
that
ass
ures
that
the
sam
ple
is r
epre
sent
ativ
e of
the
batc
h? A
re m
etho
ds o
f sam
plin
g de
sign
ed to
prev
ent c
onta
min
atio
n an
d cr
oss-
cont
amin
atio
n?D
o bu
lk d
eliv
erie
s ha
ve a
dditi
onal
con
trol
s to
ass
ure
mat
eria
l pur
ity a
nd
free
dom
from
con
tam
inat
ion
(e.g
. ded
icat
ed ta
nker
s, ta
mpe
r-ev
iden
t sea
ls,
cert
ifica
te o
f cle
anin
g, te
stin
g, a
nd/o
r au
dit o
f the
sup
plie
r?A
re th
ere
adeq
uate
writ
ten
and
appr
oved
inst
ruct
ions
and
spe
cific
atio
ns fo
rqu
ality
crit
ical
mat
eria
l sam
plin
g an
d te
stin
g, in
clud
ing
inve
stig
atio
n of
no
ncon
form
ing
resu
lts?
IPE
C-P
QG
GM
P A
UD
IT G
UID
E F
OR
PH
AR
MA
CE
UT
ICA
L E
XC
IPIE
NT
S
NO
TE
S
Cop
yrig
ht©
200
7 T
he In
tern
atio
nal P
harm
aceu
tical
Exc
ipie
nts
Cou
ncil
and
Cop
yrig
ht©
200
7 P
harm
aceu
tical
Qua
lity
Gro
up12
If qu
ality
crit
ical
mat
eria
ls a
re a
ccep
ted
on c
ertif
icat
e of
ana
lysi
s (C
OA
), is
at
leas
t an
iden
tific
atio
n te
st p
erfo
rmed
(w
hen
it is
saf
e) o
n ev
ery
batc
h an
d re
ceip
t?If
qual
ity c
ritic
al m
ater
ials
are
acc
epte
d on
CO
A, h
ave
supp
liers
bee
n ap
prop
riate
ly c
ertif
ied
or q
ualif
ied,
incl
udin
g ve
rific
atio
n an
d pe
riodi
c m
onito
ring
of th
e re
sults
on
the
CO
A?
7.5
Pro
du
ctio
n a
nd
Ser
vice
Pro
visi
on
7.5.
1C
on
tro
l of
Pro
du
ctio
n a
nd
Ser
vice
Pro
visi
on
7.5.
1.1
Pro
du
ctio
n In
stru
ctio
ns
and
Rec
ord
s
How
is th
e ex
ecut
ion
of s
igni
fican
t pro
cess
ing
step
s ve
rifie
d?A
re r
ecor
ds a
vaila
ble
and
read
ily r
etrie
vabl
e fo
r ea
ch b
atch
of
exci
pien
ts p
rodu
ced
and
does
it in
clud
e co
mpl
ete
info
rmat
ion
rela
ting
to th
e pr
oduc
tion
and
cont
rol o
f eac
h ba
tch?
Do
reco
rds
incl
ude
info
rmat
ion
such
as:
•da
te/ti
me
each
ste
p w
as c
ompl
eted
, •
iden
tific
atio
n of
per
sons
per
form
ing
and
chec
king
eac
h si
gnifi
cant
oper
atio
n,
•id
entif
icat
ion
of m
ajor
equ
ipm
ent a
nd li
nes,
•
mat
eria
l inp
uts
to e
nabl
e tr
acea
bilit
y,
•in
-pro
cess
and
labo
rato
ry c
ontr
ol r
esul
ts,
•st
atem
ent o
f yie
ld, u
nles
s no
t qua
ntifi
able
(e.
g. a
s in
som
e co
ntin
uous
pro
cess
es),
•in
spec
tion
of th
e pa
ckag
ing
and
labe
ling
area
bef
ore
and
afte
r us
e,•
labe
ling
cont
rol r
ecor
ds,
•de
scrip
tion
of s
ampl
ing
perfo
rmed
, •
failu
res,
dev
iatio
ns, i
nves
tigat
ions
and
•
resu
lts o
f fin
al p
rodu
ct in
spec
tion?
7.5.
1.2
Eq
uip
men
t Cle
anin
g
If eq
uipm
ent i
s no
t ded
icat
ed, w
hat o
ther
type
s of
mat
eria
ls a
re
man
ufac
ture
d in
the
sam
e eq
uipm
ent?
Wha
t con
trol
s ar
e us
ed to
pr
even
t cro
ss-c
onta
min
atio
n an
d ho
w h
ave
they
bee
n ju
stifi
ed (
e.g.
mod
el p
rodu
ct)?
Are
ther
e w
ritte
n cl
eani
ng p
roce
dure
s an
d do
they
con
tain
suf
ficie
ntde
tail
to a
llow
ope
rato
rs to
cle
an e
ach
type
of e
quip
men
t in
a re
prod
ucib
le a
nd e
ffect
ive
man
ner?
IPE
C-P
QG
GM
P A
UD
IT G
UID
E F
OR
PH
AR
MA
CE
UT
ICA
L E
XC
IPIE
NT
S
NO
TE
S
Cop
yrig
ht©
200
7 T
he In
tern
atio
nal P
harm
aceu
tical
Exc
ipie
nts
Cou
ncil
and
Cop
yrig
ht©
200
7 P
harm
aceu
tical
Qua
lity
Gro
up13
For
cont
inuo
us p
roce
ssin
g: is
the
freq
uenc
y of
cle
anin
g sp
ecifi
ed
and
just
ified
?A
re th
ere
data
to s
how
that
cle
anin
g pr
oced
ures
for
non-
dedi
cate
deq
uipm
ent a
re a
dequ
ate
to r
emov
e th
e pr
evio
us m
ater
ials
?H
ave
clea
ning
pro
cedu
res
been
dem
onst
rate
d to
be
effe
ctiv
e?Is
ther
e an
ade
quat
e sy
stem
for
docu
men
ting
clea
ning
and
use
of
the
equi
pmen
t (e.
g., a
cle
anin
g an
d us
e lo
g)?
Are
ute
nsils
and
sam
plin
g de
vice
s cl
eane
d an
d st
ored
in a
pro
per
man
ner
to p
reve
nt c
onta
min
atio
n?D
urin
g a
prod
uctio
n ca
mpa
ign
is th
ere
an e
stab
lishe
d in
terv
al b
etw
een
com
plet
e cl
eani
ngs
of th
e eq
uipm
ent a
nd h
as it
bee
n ju
stifi
ed?
7.5.
1.3
Rec
over
y o
f So
lven
ts, M
oth
er L
iqu
ors
an
d S
eco
nd
Cro
p
Cry
stal
lizat
ion
s
Are
rec
over
ed s
olve
nts
re-u
sed
in th
e sa
me
step
of t
he p
roce
ss o
rca
n th
ey b
e us
ed in
oth
er p
roce
sses
?If
fres
h an
d re
cove
red
solv
ents
are
com
min
gled
, are
the
reco
vere
dso
lven
ts s
ampl
ed a
nd a
ssay
ed a
nd fo
und
to b
e sa
tisfa
ctor
y pr
ior
toco
mm
ingl
ing?
How
is th
e qu
ality
of c
omm
ingl
ed s
olve
nts
mon
itore
don
an
esta
blis
hed
sche
dule
?If
seco
ndar
y re
cove
ry p
roce
dure
s ar
e pe
rform
ed o
n m
othe
r liq
uors
or
filtr
ates
, how
are
the
reco
vere
d m
ater
ials
sho
wn
to m
eet a
pplic
able
spec
ifica
tions
? A
re th
ese
reco
very
pro
cedu
res
writ
ten?
How
is
trac
eabi
lity
mai
ntai
ned?
7.5.
1.4
In-P
roce
ss B
len
din
g/M
ixin
g
Are
ther
e de
fined
ble
ndin
g/m
ixin
g pa
ram
eter
s?W
here
fini
shed
pro
duct
is b
lend
ed o
r m
ixed
, how
has
the
repr
o-du
cibi
lity
of th
e bl
endi
ng o
r m
ixin
g pr
oces
s to
ens
ure
hom
ogen
eity
been
dem
onst
rate
d?Is
the
blen
ding
/mix
ing
equi
pmen
t com
plet
ely
empt
ied
betw
een
batc
hes
or b
etw
een
cam
paig
ns?
If no
t wha
t con
trol
s ar
e ap
plie
d?A
re n
onco
nfor
min
g ba
tche
s bl
ende
d or
mix
ed w
ith o
ther
lots
that
do
conf
orm
to s
peci
ficat
ions
?H
ow a
re ta
iling
s or
par
tial c
onta
iner
s of
exc
ipie
nt h
andl
ed?
IPE
C-P
QG
GM
P A
UD
IT G
UID
E F
OR
PH
AR
MA
CE
UT
ICA
L E
XC
IPIE
NT
S
NO
TE
S
Cop
yrig
ht©
200
7 T
he In
tern
atio
nal P
harm
aceu
tical
Exc
ipie
nts
Cou
ncil
and
Cop
yrig
ht©
200
7 P
harm
aceu
tical
Qua
lity
Gro
up14
7.5.
1.5
In-P
roce
ss C
on
tro
l
How
is p
roce
ss c
ontr
ol a
ssur
ed?
For
exam
ple,
are
ther
e ap
prov
ed
inst
ruct
ions
, set
-poi
nts,
lim
its, a
nd s
peci
ficat
ions
, whe
re a
ppro
pria
te,
for
such
item
s as
at-
and
in-li
ne te
stin
g, fa
ilure
inve
stig
atio
n, p
roce
ssco
ntro
llers
, etc
.?A
re in
-pro
cess
sam
ples
take
n an
d te
st r
esul
ts r
ecor
ded?
How
are
in
-pro
cess
sam
ples
dis
pose
d of
(no
t ret
urne
d to
pro
duct
ion
for
inco
rpor
atio
n in
to th
e fin
al b
atch
)?
Hav
e pe
rson
nel p
erfo
rmin
g in
pro
cess
test
ing
been
trai
ned
and
is th
etr
aini
ng d
ocum
ente
d?
Do
man
ufac
turin
g in
stru
ctio
ns d
escr
ibe
how
to u
se in
-pro
cess
con
trol
data
to c
ontr
ol th
e pr
oces
s? H
ave
actio
ns to
be
take
n w
hen
the
resu
lts a
re o
utsi
de s
peci
fied
limits
bee
n de
fined
?W
hat i
s th
e fa
te o
f mat
eria
ls th
at fa
il to
mee
t spe
cific
atio
ns o
r ar
e pr
oduc
ed w
hen
the
proc
ess
has
been
dem
onst
rate
d to
be
outs
ide
spec
ified
lim
its?
7.5.
1.6
Pac
kag
ing
an
d L
abel
ing
Is th
ere
a w
ritte
n pr
oced
ure
for
clea
ring
the
pack
agin
g ar
ea a
fter
each
pac
kagi
ng o
pera
tion,
and
cle
anin
g be
fore
the
next
ope
ratio
n,es
peci
ally
if th
e ar
ea is
use
d fo
r pa
ckag
ing
diffe
rent
mat
eria
ls?
Do
proc
edur
es r
equi
re e
xces
s la
bels
to e
ither
be
imm
edia
tely
re
turn
ed to
con
trol
led
stor
age
or d
estr
oyed
? A
re e
xces
s la
bels
w
ith b
atch
num
bers
des
troy
ed?
How
are
labe
ls c
ontr
olle
d?Is
ther
e an
SO
P fo
r th
e re
ceiv
ing,
rev
iew
ing,
han
dlin
g, s
tora
ge,
issu
ance
, and
acc
ount
abili
ty o
f pre
-prin
ted
labe
ls?
If la
bels
are
prin
ted
as n
eede
d, w
hat s
yste
m is
use
d to
ver
ify th
e ac
cura
cy o
f the
labe
ls?
Is th
ere
a pr
oced
ure
to e
nsur
e th
at th
e pr
inte
d la
bels
con
tain
the
corr
ect i
nfor
mat
ion?
7.5.
1.7
Rec
ord
s o
f Eq
uip
men
t Use
How
is th
e se
quen
ce o
f act
iviti
es fo
r ea
ch p
iece
of e
quip
men
t de
mon
stra
ted
i.e. p
rodu
ctio
n, m
aint
enan
ce a
nd c
lean
ing?
7.5.
2 V
alid
atio
n o
f P
roce
sses
for
Pro
du
ctio
n a
nd
Ser
vice
Pro
visi
on
How
has
the
curr
ent p
roce
ss b
een
show
n to
be
capa
ble,
i.e.
, has
it b
een
dem
onst
rate
d to
ope
rate
con
sist
ently
to p
rodu
ce fi
nal m
ater
ial t
hat m
eets
es
tabl
ishe
d sp
ecifi
catio
ns fr
om b
atch
to b
atch
?
IPE
C-P
QG
GM
P A
UD
IT G
UID
E F
OR
PH
AR
MA
CE
UT
ICA
L E
XC
IPIE
NT
S
NO
TE
S
Cop
yrig
ht©
200
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he In
tern
atio
nal P
harm
aceu
tical
Exc
ipie
nts
Cou
ncil
and
Cop
yrig
ht©
200
7 P
harm
aceu
tical
Qua
lity
Gro
up15
Wha
t tec
hniq
ues
are
used
to d
emon
stra
te o
ngoi
ng p
roce
ss c
apab
ility
? H
ow is
it re
view
ed?
Wha
t det
erm
ines
the
need
for
reva
lidat
ion?
7.5.
3Id
enti
fica
tio
n a
nd
Tra
ceab
ility
7.5.
3.1
Trac
eab
ility
Is th
ere
a sy
stem
in p
lace
to tr
ace
qual
ity-c
ritic
al m
ater
ials
bac
k to
thei
r or
igin
al m
anuf
actu
rers
?Is
an
iden
tific
atio
n co
de a
ssoc
iate
d w
ith e
ach
lot o
f inc
omin
g qu
ality
-cr
itica
l mat
eria
l to
enab
le tr
acea
bilit
y in
the
man
ufac
turin
g op
erat
ion?
Are
bat
ch /
lot n
umbe
rs a
ssig
ned
such
that
they
are
not
dup
licat
edan
d en
able
trac
ing
of a
ll pr
oces
ses
and
batc
h re
cord
s fo
r ea
ch b
atch
?If
proc
essi
ng is
on
a co
ntin
uous
bas
is, h
ow is
a b
atch
def
ined
? Is
the
timef
ram
e du
ring
whi
ch a
par
ticul
ar b
atch
of q
ualit
y-cr
itica
l mat
eria
lw
as p
roce
ssed
thro
ugh
the
plan
t doc
umen
ted?
If a
new
lot n
umbe
r is
ass
igne
d to
a r
epro
cess
ed lo
t, ca
n it
be tr
aced
to th
e or
igin
al b
atch
?If
mul
tiple
site
s pr
oduc
e th
is m
ater
ial,
how
can
the
man
ufac
turin
g si
tebe
det
erm
ined
?
7.5.
3.2
Insp
ectio
n a
nd
Tes
t Sta
tus
Are
qua
lity-
criti
cal m
ater
ials
app
rove
d be
fore
bei
ng u
sed
in
prod
uctio
n? H
ave
requ
irem
ents
bee
n de
fined
for
cont
inuo
usly
fed
qual
ity-c
ritic
al m
ater
ials
?W
hat c
ontr
ols
are
exer
cise
d to
ass
ure
that
qua
lity-
criti
cal m
ater
ials
are
not u
sed
in a
bat
ch p
rior
to r
elea
se b
y th
e Q
ualit
y U
nit?
How
are
con
tain
ers
and
equi
pmen
t lab
eled
to c
lear
ly id
entif
y th
e co
nten
ts a
nd, i
f app
ropr
iate
, the
sta
ge o
f man
ufac
ture
?W
hat s
yste
m is
use
d to
iden
tify
the
stat
us o
f all
qual
ity-c
ritic
al
mat
eria
ls, i
nter
med
iate
s an
d fin
ishe
d pr
oduc
ts?
If fil
led
unla
bele
d co
ntai
ners
are
set
asi
de fo
r fu
ture
labe
ling,
is th
ere
suffi
cien
t ide
ntifi
catio
n to
det
erm
ine
chem
ical
iden
tity,
qua
ntity
, lot
num
ber,
and
othe
r in
form
atio
n ne
eded
for
trac
eabi
lity?
Is th
ere
an e
ffect
ive
syst
em fo
r m
onito
ring
and
rete
stin
g or
re
-eva
luat
ing
stor
ed q
ualit
y-cr
itica
l mat
eria
ls to
ass
ure
that
they
are
not u
sed
beyo
nd th
eir
reco
mm
ende
d ex
pira
tion
or u
se d
ate?
Are
qua
rant
ine
proc
edur
es e
stab
lishe
d w
ith d
esig
nate
d ar
eas,
labe
ls,
or w
ith a
sui
tabl
y co
ntro
lled
com
pute
r sy
stem
?
IPE
C-P
QG
GM
P A
UD
IT G
UID
E F
OR
PH
AR
MA
CE
UT
ICA
L E
XC
IPIE
NT
S
NO
TE
S
Cop
yrig
ht©
200
7 T
he In
tern
atio
nal P
harm
aceu
tical
Exc
ipie
nts
Cou
ncil
and
Cop
yrig
ht©
200
7 P
harm
aceu
tical
Qua
lity
Gro
up16
7.5.
3.3
Lab
elin
g
Doe
s th
e fin
al p
rodu
ct la
bel c
onta
in a
dequ
ate
info
rmat
ion
to id
entif
yth
e co
nten
ts, q
uant
ity, b
atch
num
ber,
and
man
ufac
ture
r?If
spec
ial s
tora
ge c
ondi
tions
are
nec
essa
ry, b
ased
on
the
resu
lts o
fst
abili
ty te
stin
g, a
re th
ey s
peci
fied
on th
e la
bel?
7.5.
4C
ust
om
er P
rop
erty
If a
cust
omer
sup
plie
s m
ater
ials
for i
ncor
pora
tion
into
the
cust
omer
’s e
xcip
ient
,w
hat s
yste
ms
and
proc
edur
es a
re in
pla
ce fo
r han
dlin
g su
ch m
ater
ials
, inc
ludi
ngve
rific
atio
n, s
tora
ge, m
aint
enan
ce, a
nd a
ccou
ntab
ility
for l
oss
or d
amag
e?H
ow a
re m
ater
ials
sup
plie
d to
the
exci
pien
t pro
duce
r by
the
cust
omer
han
dled
?Is
ther
e a
tech
nica
l or
com
mer
cial
agr
eem
ent i
n pl
ace
to e
nsur
e th
e co
nfid
entia
lity
of a
ny in
telle
ctua
l pro
pert
y pr
ovid
ed b
y th
e cu
stom
er?
How
is th
is c
ontr
olle
d by
the
exci
pien
t man
ufac
ture
r?
7.5.
5P
rese
rvat
ion
of
Pro
du
ct
7.5.
5.1
Han
dlin
g, S
tora
ge,
an
d P
rese
rvat
ion
Is th
e w
areh
ouse
cle
an a
nd w
ell o
rgan
ized
, and
mat
eria
ls e
asily
lo
cate
d? Is
ther
e ad
equa
te s
pace
for
pest
con
trol
and
hou
seke
epin
g?D
oes
the
exci
pien
t man
ufac
ture
r ha
ve a
ny s
cien
tific
evi
denc
e (e
.g.
stab
ility
dat
a) to
indi
cate
acc
epta
ble
cond
ition
s fo
r th
e st
orag
e of
the
exci
pien
t? Is
it k
now
n if
hum
idity
, tem
pera
ture
, or
prot
ectio
n fr
om
light
etc
. are
nec
essa
ry c
ontr
ols
to p
rote
ct th
e ex
cipi
ent?
Are
thes
eco
ntro
ls in
pla
ce?
Are
app
ropr
iate
rec
ords
in p
lace
to d
emon
stra
teth
e im
plem
enta
tion
of th
ese
cont
rols
?W
here
raw
mat
eria
ls o
r in
term
edia
tes
are
stor
ed in
silo
s, ta
nks
orot
her
larg
e co
ntai
ners
, how
is th
e di
spen
sing
of s
uch
mat
eria
ls
mon
itore
d fo
r ap
prop
riate
acc
urac
y?If
mat
eria
ls a
re s
tore
d ou
tsid
e, d
o th
e co
ntai
ners
giv
e ac
cept
able
pr
otec
tion
to th
e co
nten
ts?
Are
labe
ls in
delib
le?
Are
suc
h co
ntai
ners
clea
ned
befo
re th
eir
cont
ents
are
sub
ject
ed to
furt
her
proc
essi
ng?
How
is s
tock
rot
atio
n m
anag
ed (
e.g.
Firs
t in
Firs
t out
; Firs
t exp
ired
Firs
t out
)?
7.5.
5.2
Pac
kag
ing
Sys
tem
s
Wha
t doc
umen
tatio
n su
ppor
ts th
e us
e of
the
cont
aine
r/cl
osur
e sy
stem
, dem
onst
ratin
g th
at it
is a
dequ
ate
to p
rote
ct p
rodu
ct fr
om
dete
riora
tion
and
cont
amin
atio
n an
d th
at it
doe
s no
t alte
r th
e ex
cipi
ent b
eyon
d its
spe
cific
atio
ns?
IPE
C-P
QG
GM
P A
UD
IT G
UID
E F
OR
PH
AR
MA
CE
UT
ICA
L E
XC
IPIE
NT
S
NO
TE
S
Cop
yrig
ht©
200
7 T
he In
tern
atio
nal P
harm
aceu
tical
Exc
ipie
nts
Cou
ncil
and
Cop
yrig
ht©
200
7 P
harm
aceu
tical
Qua
lity
Gro
up17
How
are
pro
duct
con
tain
ers
and
clos
ures
han
dled
and
sto
red
in o
rder
to p
rote
ct th
em fr
om c
onta
min
atio
n an
d de
terio
ratio
n, a
nd to
pre
vent
mix
-ups
?If
retu
rnab
le e
xcip
ient
con
tain
ers
are
reus
ed, a
re th
ey c
lean
ed u
sing
appr
opria
te c
lean
ing
proc
edur
es a
nd in
spec
ted
befo
re u
se?
Are
pr
evio
us la
bels
rem
oved
or
defa
ced?
If pr
oduc
t is
pack
aged
in tr
ucks
or
railr
oad
cars
, whe
re is
the
clea
ning
of th
e tr
ucks
and
car
s do
cum
ente
d? Is
ther
e a
reco
rd o
f the
pre
viou
spr
oduc
t in
the
truc
k or
rai
lroad
car
?Fo
r no
n-de
dica
ted
truc
ks a
nd r
ailro
ad c
ars,
how
is it
ass
ured
that
ther
e ar
e no
obj
ectio
nabl
e re
sidu
es fr
om p
rior
mat
eria
ls?
Are
all
truc
ks a
nd r
ailro
ad c
ars
insp
ecte
d be
fore
bei
ng fi
lled
with
pr
oduc
t?A
re ta
mpe
r-ev
iden
t sea
ls u
sed
whe
re p
ossi
ble,
incl
udin
g on
truc
ksan
d ra
ilroa
d ca
rs?
7.5.
5.3
Del
iver
y an
d D
istr
ibu
tion
Are
ade
quat
e di
strib
utio
n re
cord
s m
aint
aine
d fo
r all
prod
uct s
hipm
ents
?D
o sh
ippi
ng r
ecor
ds a
llow
trac
eabi
lity
of th
e ba
tch
to s
peci
fic
cons
igne
es a
nd v
ice
vers
a in
cas
e of
a r
etrie
val?
Is th
ere
an S
OP
for
cond
uctin
g a
prod
uct r
etrie
val o
r m
arke
t w
ithdr
awal
? H
ow a
nd w
hen
was
the
proc
edur
e la
st v
erifi
ed?
7.6
Co
ntr
ol o
f M
easu
rin
g a
nd
Mo
nit
ori
ng
Dev
ices
Are
ther
e pr
oced
ures
for
calib
ratio
n of
qua
lity-
criti
cal e
quip
men
t and
for
mea
surin
gan
d te
st in
stru
men
ts?
Do
the
proc
edur
es a
ssig
n re
spon
sibi
litie
s; in
clud
e sc
hedu
les;
desc
ribe
met
hods
, equ
ipm
ent,
and
mat
eria
ls to
be
used
, inc
ludi
ng s
tand
ards
tr
acea
ble
to n
atio
nal s
tand
ards
; def
ine
re-c
alib
ratio
n fr
eque
ncy
and
limits
for
accu
racy
and
pre
cisi
on a
nd r
equi
re m
aint
enan
ce o
f rec
ords
?If
calib
ratio
n op
erat
ions
are
per
form
ed in
-hou
se, d
o th
e pr
oced
ures
spe
cify
ha
ndlin
g an
d st
orag
e co
nditi
ons
for
the
trac
eabl
e st
anda
rds?
Is th
ere
a pr
oced
ure
spec
ifyin
g th
at e
quip
men
t and
inst
rum
ents
can
not b
e us
ed if
they
are
bey
ond
the
calib
ratio
n du
e da
te?
Wha
t act
ions
doe
s th
e ca
libra
tion
proc
edur
e de
scrib
e to
be
take
n re
gard
ing
mea
sure
men
ts d
one
usin
g eq
uipm
ent o
r an
inst
rum
ent t
hat i
s su
bseq
uent
ly fo
und
to h
ave
been
bey
ond
the
due
date
or
out o
f cal
ibra
tion
limits
, and
doe
s it
requ
iredo
cum
enta
tion
of s
uch
actio
ns?
IPE
C-P
QG
GM
P A
UD
IT G
UID
E F
OR
PH
AR
MA
CE
UT
ICA
L E
XC
IPIE
NT
S
NO
TE
S
Cop
yrig
ht©
200
7 T
he In
tern
atio
nal P
harm
aceu
tical
Exc
ipie
nts
Cou
ncil
and
Cop
yrig
ht©
200
7 P
harm
aceu
tical
Qua
lity
Gro
up18
How
is th
e cu
rren
t cal
ibra
tion
stat
us o
f qua
lity-
criti
cal i
nstr
umen
ts a
nd e
quip
men
tkn
own
to u
sers
?W
here
are
rec
ords
or
logs
mai
ntai
ned
for
calib
ratio
n op
erat
ions
?W
hat i
s th
e sy
stem
for
rout
ine
verif
icat
ion
that
suc
h eq
uipm
ent a
s sc
ales
, pH
m
eter
s, a
nd H
PLC
per
form
as
desi
gned
?
8.M
EA
SU
RE
ME
NT,
AN
ALY
SIS
AN
D IM
PR
OV
EM
EN
T
8.1
Gen
eral
Do
mon
itorin
g an
d m
easu
ring
activ
ities
incl
ude
the
qual
ity m
anag
emen
t sys
tem
s as
wel
l as
para
met
ers
that
def
ine
exci
pien
t qua
lity?
8.2
Mo
nit
ori
ng
an
d M
easu
rem
ent
8.2.
1C
ust
om
er S
atis
fact
ion
How
is c
usto
mer
sat
isfa
ctio
n de
term
ined
? A
re p
aram
eter
s su
ch a
s cu
stom
erco
mpl
aint
s an
d re
turn
of e
xcip
ient
s co
vere
d?D
oes
this
ana
lysi
s dr
ive
impr
ovem
ent a
ctiv
ities
?
8.2.
2In
tern
al A
ud
it
Is th
ere
an in
tern
al q
ualit
y au
dit p
rogr
am th
at c
over
s al
l are
as o
f the
ope
ratio
nto
ver
ify th
at S
OP
s an
d ot
her
proc
edur
es a
nd p
olic
ies
are
bein
g fo
llow
ed, a
ndto
det
erm
ine
effe
ctiv
enes
s of
the
Qua
lity
Sys
tem
? A
re a
udits
per
form
ed a
tsp
ecifi
ed in
terv
als?
Are
aud
its s
ched
uled
on
the
impo
rtan
ce a
nd s
tatu
s of
the
activ
ity p
erfo
rmed
?A
re in
tern
al a
udits
doc
umen
ted?
Are
man
agem
ent p
erso
nnel
aw
are
of th
e au
dit f
indi
ngs
and
the
corr
ectiv
e ac
tions
to b
e ta
ken?
Are
nec
essa
ry s
teps
take
n to
cor
rect
any
are
as o
f non
-com
plia
nce
base
d on
the
findi
ngs
and
reco
mm
enda
tions
of t
he in
tern
al a
udits
? W
ho is
res
pons
ible
for
impl
emen
ting
the
corr
ectiv
e ac
tions
?H
ow a
re c
orre
ctiv
e ac
tions
doc
umen
ted?
Do
follo
w-u
p au
dit a
ctiv
ities
incl
ude
verif
icat
ion
of th
e ef
fect
iven
ess
of
corr
ectiv
e ac
tions
?
8.2.
3M
on
ito
rin
g a
nd
Mea
sure
men
t o
f P
roce
sses
Are
crit
ical
pro
cess
con
trol
poi
nts
and
prod
uct c
hara
cter
istic
s un
der
cont
rol?
A
re a
ppro
pria
te te
chni
ques
app
lied
to v
erify
this
? A
re th
ere
docu
men
ted
proc
edur
es d
efin
ing
the
impl
emen
tatio
n an
d co
ntro
l of
thes
e te
chni
ques
?IPE
C-P
QG
GM
P A
UD
IT G
UID
E F
OR
PH
AR
MA
CE
UT
ICA
L E
XC
IPIE
NT
S
NO
TE
S
Cop
yrig
ht©
200
7 T
he In
tern
atio
nal P
harm
aceu
tical
Exc
ipie
nts
Cou
ncil
and
Cop
yrig
ht©
200
7 P
harm
aceu
tical
Qua
lity
Gro
up19
Wha
t mon
itorin
g oc
curs
of t
he m
anag
emen
t sys
tem
pro
cess
and
pro
cess
fa
ilure
s?H
ow a
re o
ut o
f tre
nd a
nd d
evia
tions
not
ed?
Wha
t act
ions
are
take
n w
hen
thes
e ha
ppen
?
8.2.
4M
on
ito
rin
g a
nd
Mea
sure
men
t o
f P
rod
uct
Are
test
met
hods
doc
umen
ted?
Wha
t evi
denc
e is
ther
e th
at th
e te
st m
etho
ds a
re fi
t for
pur
pose
?If
the
exci
pien
t is
clai
med
to b
e co
mpl
iant
to c
ompe
ndia
l req
uire
men
ts, a
re th
ete
st m
etho
ds th
ose
defin
ed in
the
appr
opria
te p
harm
acop
eia?
If n
ot, h
as th
ete
st m
etho
d be
en s
how
n to
pro
vide
equ
ival
ent r
esul
ts?
Is th
ere
an a
dequ
ate
syst
em fo
r re
view
ing
and
impl
emen
ting
com
pend
ial
chan
ges?
Are
per
iodi
c re
view
s of
pro
duct
qua
lity
and
conf
orm
ance
mea
sure
s co
nduc
ted?
8.2.
4.1
Lab
ora
tory
Co
ntr
ols
Do
labo
rato
ry r
ecor
ds c
onta
in:
•A
sam
ple
desc
riptio
n?•
Bat
ch n
umbe
r?•
Dat
e sa
mpl
e w
as ta
ken?
•Te
st m
etho
d re
fere
nce(
s)?
•R
aw d
ata?
•C
alcu
latio
ns?
•Te
st r
esul
ts a
nd th
eir
com
paris
on to
spe
cific
atio
n?•
Iden
tity
of a
naly
st(s
) an
d th
e da
te e
ach
test
was
per
form
ed?
Are
rea
gent
s an
d so
lutio
ns p
rope
rly la
bele
d? A
re th
ey tr
acea
ble
tore
cord
s de
scrib
ing
thei
r pr
epar
atio
n? D
o th
ey h
ave
an e
xpiry
dat
e in
dica
ted?
Is th
ere
a pr
oced
ure
in p
lace
for
thes
e ac
tiviti
es?
Are
ther
ere
cord
s of
any
sta
ndar
diza
tion?
Are
ref
eren
ce s
tand
ards
pro
perly
labe
led
and
stor
ed in
a m
anne
r to
prot
ect t
hem
from
det
erio
ratio
n? A
re C
ertif
icat
es o
f Ana
lysi
s (C
OA
s)fr
om s
uppl
iers
of p
rimar
y re
fere
nce
stan
dard
s av
aila
ble?
Is th
ere
apr
oced
ure
for
qual
ifica
tion
of s
econ
dary
ref
eren
ce s
tand
ards
incl
udin
gde
finiti
on o
f the
req
ualif
icat
ion
perio
d?
8.2.
4.2
Fin
ish
ed E
xcip
ien
t Tes
ting
an
d R
elea
se
Are
ther
e co
mpl
ete
writ
ten
and
appr
oved
inst
ruct
ions
for
perfo
rmin
gte
stin
g of
fina
l pro
duct
that
spe
cify
met
hods
, equ
ipm
ent,
oper
atin
g pa
ram
eter
s, a
ccep
tanc
e sp
ecifi
catio
ns?
IPE
C-P
QG
GM
P A
UD
IT G
UID
E F
OR
PH
AR
MA
CE
UT
ICA
L E
XC
IPIE
NT
S
NO
TE
S
Cop
yrig
ht©
200
7 T
he In
tern
atio
nal P
harm
aceu
tical
Exc
ipie
nts
Cou
ncil
and
Cop
yrig
ht©
200
7 P
harm
aceu
tical
Qua
lity
Gro
up20
How
doe
s th
e Q
ualit
y U
nit p
erfo
rm b
atch
rel
ease
incl
udin
g re
view
of
appr
opria
te m
anuf
actu
ring,
pac
kagi
ng, l
abel
ing,
and
test
ing
reco
rds
befo
re b
atch
es a
re r
elea
sed
for
sale
?Is
eve
ry p
rodu
ct b
atch
test
ed a
nd a
ppro
ved
befo
re s
hipm
ent?
If n
ot,
has
the
use
of r
educ
ed te
stin
g be
en ju
stifi
ed?
Wha
t con
trol
s ar
e ap
plie
d to
ass
ure
that
the
exci
pien
t con
form
s to
the
docu
men
ted
spec
ifica
tions
whe
n th
e ex
cipi
ent i
s m
anuf
actu
red
usin
ga
cont
inuo
us p
roce
ss?
8.2.
4.3
Ou
t-o
f-S
pec
ifica
tion
Tes
t Res
ults
Is th
ere
an S
OP
for
inve
stig
atio
n of
Out
-of-
Spe
cific
atio
n (O
OS
) re
sults
and
ret
estin
g, in
clud
ing
a ta
rget
tim
e fr
ame
for
com
plet
ing
inve
stig
atio
ns?
How
are
the
resu
lts e
valu
ated
? U
nder
wha
t con
ditio
ns m
ay a
n O
OS
resu
lt be
dis
coun
ted?
If st
atis
tical
met
hods
are
use
d in
the
eval
uatio
n of
an
OO
S a
re th
eydo
cum
ente
d in
the
rele
vant
SO
P?
Are
inve
stig
atio
ns c
ompl
eted
and
mat
ters
res
olve
d be
fore
bat
ch
rele
ase?
Has
the
impa
ct o
n la
bora
tory
ope
ratio
ns, o
ther
equ
ipm
ent,
batc
hes,
prod
ucts
, etc
. bee
n co
nsid
ered
?
8.2.
4.4
Ret
ain
ed S
amp
les
Are
ret
aine
d sa
mpl
es k
ept f
or e
very
bat
ch fo
r an
app
ropr
iate
inte
rval
?H
ow is
this
inte
rval
def
ined
? D
oes
it re
late
to th
e ex
piry
or
rete
st
inte
rval
ass
igne
d to
the
exci
pien
t? Is
this
doc
umen
ted?
Is th
e re
tain
ed s
ampl
e si
ze a
t lea
st tw
ice
the
amou
nt r
equi
red
to
perfo
rm a
ll sp
ecifi
catio
n te
stin
g?A
re r
etai
ned
sam
ples
app
ropr
iate
ly p
acka
ged
and
stor
ed?
8.2.
4.5
Cer
tific
ates
of A
nal
ysis
(CO
As)
Doe
s th
e ex
cipi
ent m
anuf
actu
rer
prov
ide
CO
As
for
each
bat
ch?
Do
they
com
ply
with
rec
ogni
zed
guid
ance
?D
oes
the
CO
A c
onta
in s
uffic
ient
info
rmat
ion
for
the
inte
nded
use
of
the
exci
pien
t?H
ow a
re th
e re
sults
det
erm
ined
for
each
test
rep
orte
d on
the
CO
A?
Issk
ip lo
t tes
ting
perfo
rmed
and
indi
cate
d?
IPE
C-P
QG
GM
P A
UD
IT G
UID
E F
OR
PH
AR
MA
CE
UT
ICA
L E
XC
IPIE
NT
S
NO
TE
S
Cop
yrig
ht©
200
7 T
he In
tern
atio
nal P
harm
aceu
tical
Exc
ipie
nts
Cou
ncil
and
Cop
yrig
ht©
200
7 P
harm
aceu
tical
Qua
lity
Gro
up21
8.2.
4.6
Imp
uri
ties
Are
impu
ritie
s kn
own
and
limits
est
ablis
hed?
Hav
e ap
prop
riate
sa
fety
dat
a, r
equi
rem
ents
of o
ffici
al c
ompe
ndia
and
/or
soun
d G
MP
cons
ider
atio
ns b
een
cons
ider
ed in
est
ablis
hing
thos
e lim
its?
Are
man
ufac
turin
g pr
oces
ses
adeq
uate
ly c
ontr
olle
d in
ord
er to
avo
idex
ceed
ing
such
lim
its?
Is te
stin
g pe
rform
ed o
n th
e fin
ishe
d m
ater
ial f
or r
esid
ual s
olve
nts
(esp
ecia
lly th
ose
used
in c
ryst
alliz
atio
n an
d fin
al w
ashe
s) if
use
d in
the
proc
ess?
Are
thes
e re
sults
incl
uded
on
the
CO
A?
8.2.
4.7
Sta
bili
ty
Is s
tabi
lity
or h
isto
rical
dat
a av
aila
ble
to s
uppo
rt th
e re
com
men
ded
stor
age
cond
ition
s?If
an e
xpira
tion
/ re-
eval
uatio
n in
terv
al h
as b
een
assi
gned
how
is th
isin
terv
al d
eter
min
ed?,
Was
it b
ased
on
data
from
a s
tabi
lity
stud
y on
this
pro
duct
or
a si
mila
r pr
oduc
t (“m
odel
pro
duct
” app
roac
h)?
If a
“mod
el p
rodu
ct” a
ppro
ach
is fo
llow
ed, i
s th
ere
a sc
ient
ifica
llyso
und
and
docu
men
ted
ratio
nale
for
the
sele
cted
pro
duct
s?Is
ther
e a
writ
ten
stab
ility
pro
gram
, app
rove
d by
the
Qua
lity
Uni
t tha
tsp
ecifi
es s
ampl
e si
ze, s
tora
ge c
ondi
tions
, tes
ting
inte
rval
s, a
nd te
sts
to b
e pe
rform
ed?
Doe
s th
e co
ntai
ner
used
in s
tabi
lity
test
ing
sim
ulat
e th
e m
arke
t co
ntai
ner?
Are
ass
ay m
etho
ds fo
r st
abili
ty te
stin
g st
abili
ty in
dica
ting?
How
are
sta
bilit
y da
ta r
evie
wed
and
tren
ds m
onito
red,
adv
erse
tren
dsad
dres
sed,
and
app
ropr
iate
man
agem
ent n
otifi
ed?
8.2.
4.8
Exp
iry/
Ret
est P
erio
ds
Is a
n ex
pira
tion
or r
e-ev
alua
tion
date
ass
igne
d to
the
mat
eria
l? I
f so,
wha
t is
it? W
here
is it
list
ed s
o as
to in
form
the
cust
omer
?
8.3
Co
ntr
ol o
f N
on
con
form
ing
Pro
du
ct
Is th
ere
a pr
oced
ure
for
dete
rmin
ing
the
fate
of f
inal
pro
duct
that
fails
to m
eet
spec
ifica
tions
(e.
g., r
epro
cess
ing,
dow
ngra
ding
to a
less
er g
rade
, rel
ease
with
agre
emen
t of t
he c
usto
mer
, des
truc
tion)
?W
hat r
ecor
ds a
re m
aint
aine
d of
non
conf
orm
ing
prod
uct,
rela
ted
inve
stig
atio
ns a
ndco
rrec
tive
actio
ns?
How
are
non
conf
orm
ing
prod
ucts
cle
arly
iden
tifie
d an
d se
greg
ated
to p
reve
nt
unin
tent
iona
l usa
ge o
r sa
le?
IPE
C-P
QG
GM
P A
UD
IT G
UID
E F
OR
PH
AR
MA
CE
UT
ICA
L E
XC
IPIE
NT
S
NO
TE
S
Cop
yrig
ht©
200
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he In
tern
atio
nal P
harm
aceu
tical
Exc
ipie
nts
Cou
ncil
and
Cop
yrig
ht©
200
7 P
harm
aceu
tical
Qua
lity
Gro
up22
If pr
oduc
t is
to b
e de
stro
yed,
is it
trac
ked,
con
trol
led,
and
des
troy
ed in
a ti
mel
y an
dap
prop
riate
fash
ion?
Are
rec
ords
of s
uch
dest
ruct
ion
mai
ntai
ned?
Is th
ere
a pr
oced
ure
that
des
crib
es h
ow a
n ex
cipi
ent c
an b
e re
trie
ved
from
di
strib
utio
n? A
re r
ecor
ds k
ept o
f suc
h ac
tiviti
es?
8.3.
1R
epro
cess
ing
If re
proc
essi
ng (
repe
atin
g st
eps
that
are
alre
ady
part
of t
he n
orm
al p
roce
ss)
is p
erfo
rmed
, whe
re a
re c
ompl
ete
writ
ten
inst
ruct
ions
foun
d in
clud
ing
any
addi
tiona
l tes
ting
that
may
be
requ
ired?
8.3.
2R
ewo
rkin
g
If re
wor
king
(pe
rform
ing
step
s th
at a
re n
ot p
art o
f the
nor
mal
pro
cess
) is
pe
rform
ed, i
s th
ere
a do
cum
ente
d re
view
of r
isk
to e
xcip
ient
qua
lity
and
appr
oval
by
the
Qua
lity
Uni
t?If
rew
orki
ng is
per
form
ed, i
s th
ere
suffi
cien
t inv
estig
atio
n, e
valu
atio
n an
d do
cum
enta
tion
to a
ssur
e th
at th
e fin
al p
rodu
ct is
at l
east
equ
ival
ent t
o ot
her
acce
ptab
le p
rodu
ct, m
eetin
g al
l est
ablis
hed
stan
dard
s, s
peci
ficat
ions
and
char
acte
ristic
s? Is
the
impa
ct o
n st
abili
ty, i
mpu
ritie
s, e
tc. c
onsi
dere
d an
d ar
eap
prop
riate
con
trol
s ap
plie
d fo
r th
ese
issu
es?
Are
indi
vidu
al n
on-c
onfo
rmin
g ba
tche
s bl
ende
d w
ith o
ther
s?
8.3.
3R
etu
rned
Exc
ipie
nts
Is th
ere
a pr
oced
ure
for
hand
ling
retu
rned
goo
ds, i
nclu
ding
pro
per
iden
tific
a-tio
n, s
egre
gate
d st
orag
e, te
stin
g, a
nd Q
ualit
y U
nit i
nvol
vem
ent i
n th
e ev
alua
-tio
n an
d de
term
inat
ion
of it
s fa
te?
Whe
re a
re r
ecor
ds o
f ret
urne
d go
ods
mai
ntai
ned
and
do th
ose
reco
rds
in-
clud
e th
e ap
prop
riate
info
rmat
ion?
If re
turn
ed g
oods
are
to b
e re
proc
esse
d or
dis
pose
d of
, is
it do
ne a
ccor
ding
toa
proc
edur
e, w
ith Q
ualit
y U
nit i
nvol
vem
ent?
Whe
re is
it d
ocum
ente
d?
8.4
An
alys
is o
f D
ata
Is th
e ef
fect
iven
ess
of th
e Q
ualit
y M
anag
emen
t Sys
tem
eva
luat
ed?
Wha
t mea
sure
s ar
e us
ed a
nd w
hat d
ata
is c
onsi
dere
d to
per
form
this
ana
lysi
s?A
re th
ere
perio
dic
revi
ews
of k
ey in
dica
tors
? W
hat a
re th
ese
indi
cato
rs?
8.5
Imp
rove
men
t
8.5.
1C
on
tin
ual
Imp
rove
men
t
Wha
t inp
uts
driv
e co
ntin
ual i
mpr
ovem
ent a
ctiv
ities
? H
ow a
re th
ese
man
aged
?
IPE
C-P
QG
GM
P A
UD
IT G
UID
E F
OR
PH
AR
MA
CE
UT
ICA
L E
XC
IPIE
NT
S
NO
TE
S
Cop
yrig
ht©
200
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he In
tern
atio
nal P
harm
aceu
tical
Exc
ipie
nts
Cou
ncil
and
Cop
yrig
ht©
200
7 P
harm
aceu
tical
Qua
lity
Gro
up23
Wha
t pro
cedu
res
are
esta
blis
hed
for
inve
stig
atio
n of
non
conf
orm
ing
prod
ucts
,re
turn
s, c
ompl
aint
s, e
tc.?
How
are
thes
e ca
uses
det
erm
ined
and
how
are
ap
prop
riate
par
ties,
incl
udin
g m
anag
emen
t, no
tifie
d?
8.5.
2C
orr
ecti
ve A
ctio
n
Are
pro
cedu
res
for
corr
ectiv
e ac
tions
impl
emen
ted
to a
ddre
ss th
e ro
ot c
ause
sof
non
conf
orm
ing
prod
ucts
, ret
urns
, and
com
plai
nts?
Are
ther
e pr
oced
ures
in p
lace
to c
over
how
cus
tom
er c
ompl
aint
s, r
etrie
vals
etc
are
rece
ived
and
wha
t act
ions
are
take
n?
8.5.
3P
reve
nti
ve A
ctio
n
Are
pro
cedu
res
for
prev
entiv
e ac
tions
impl
emen
ted
to a
ddre
ss p
robl
ems
at a
leve
l cor
resp
ondi
ng to
the
risk?
IPE
C-P
QG
GM
P A
UD
IT G
UID
E F
OR
PH
AR
MA
CE
UT
ICA
L E
XC
IPIE
NT
S
NO
TE
S
Cop
yrig
ht©
200
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he In
tern
atio
nal P
harm
aceu
tical
Exc
ipie
nts
Cou
ncil
and
Cop
yrig
ht©
200
7 P
harm
aceu
tical
Qua
lity
Gro
up24
Cop
yrig
ht©
200
7 T
he In
tern
atio
nal P
harm
aceu
tical
Exc
ipie
nts
Cou
ncil
and
Cop
yrig
ht©
200
7 P
harm
aceu
tical
Qua
lity
Gro
up
TH
E IN
TE
RN
AT
ION
AL
PH
AR
MA
CE
UT
ICA
L E
XC
IPIE
NT
S C
OU
NC
ILP
HA
RM
AC
EU
TIC
AL
QU
AL
ITY
GR
OU
P
GM
P A
UD
IT G
UID
EFO
R
PH
AR
MA
CEU
TIC
AL
EXC
IPIE
NTS
FO
RM
AT:
RE
MIN
DE
R P
HR
AS
ES
IN S
EQ
UE
NC
E
OF
TH
E J
OIN
T G
MP
GU
IDE
4 Q
UA
LIT
Y M
AN
AG
EM
EN
T S
YS
TE
M-E
XC
IPIE
NT
QU
AL
ITY
SY
ST
EM
S
4.1
Gen
eral
Req
uir
emen
ts
4.2
Do
cum
enta
tio
n R
equ
irem
ents
4.2.
1G
ener
al
4.2.
2Q
ual
ity
Man
ual
4.2.
3C
on
tro
l of
Do
cum
ents
4.2.
4C
on
tro
l of
Rec
ord
s
4.3
Ch
ang
e C
on
tro
l
5.
MA
NA
GE
ME
NT
RE
SP
ON
SIB
ILIT
Y
5.1
Man
agem
ent
Co
mm
itm
ent
5.2
Cu
sto
mer
Fo
cus
5.3
Qu
alit
y P
olic
y
5.4
Pla
nn
ing
5.4.
1Q
ual
ity
Ob
ject
ives
5.4.
2Q
ual
ity
Man
agem
ent
Sys
tem
Pla
nn
ingIP
EC
-PQ
G G
MP
AU
DIT
GU
IDE
FO
R P
HA
RM
AC
EU
TIC
AL
EX
CIP
IEN
TS
CO
MM
EN
TS
GM
P S
EC
TIO
NIT
EM
Cop
yrig
ht©
200
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he In
tern
atio
nal P
harm
aceu
tical
Exc
ipie
nts
Cou
ncil
and
Cop
yrig
ht©
200
7 P
harm
aceu
tical
Qua
lity
Gro
up1
•Q
ualit
y M
anua
l•
Qua
lity
Pol
icy
•G
MP
sta
rtin
g po
int
•W
ritte
n m
anuf
actu
ring
inst
ruct
ions
•P
roce
ss fu
lly d
escr
ibed
•Ve
rific
atio
n of
sig
nific
ant s
teps
•S
OP
ava
ilabi
lity
and
cont
rol
•P
erio
dic
revi
ew o
f SO
Ps
•E
lect
roni
c co
ntro
l
•R
ecor
d re
tent
ion
SO
P•
Goo
d D
ocum
enta
tion
Pra
ctic
es
•C
hang
e co
ntro
l pro
cedu
re•
Con
trol
of p
rodu
ctio
n ch
ange
s•
Inde
pend
ent a
ppro
val o
f cha
nges
•Im
pact
on
qual
ifica
tion
or v
alid
atio
n•
Cha
nge
cont
rol l
og•
Not
ifica
tion
to c
usto
mer
s &
reg
ulat
ory
•C
omm
itmen
t to
cust
omer
sat
isfa
ctio
n•
Com
mitm
ent t
o G
MP
com
plia
nce
•C
usto
mer
req
uire
men
ts•
Cus
tom
er a
udit
polic
y
•P
olic
y de
ploy
men
t, m
anag
emen
t su
ppor
t•
Con
tinua
l im
prov
emen
t
•M
easu
rabl
e co
nfor
man
ce o
bjec
tives
•C
onfo
rman
ce o
bjec
tives
•A
dequ
ate
reso
urce
s
5.5
Res
po
nsi
bili
ty, A
uth
ori
ty
and
Co
mm
un
icat
ion
5.5.
1R
esp
on
sib
ility
an
d A
uth
ori
ty
5.5.
2M
anag
emen
t R
epre
sen
tati
ve
5.5.
3In
tern
al C
om
mu
nic
atio
n
5.6
Man
agem
ent
Rev
iew
5.6.
1G
ener
al
5.6.
2R
evie
w In
pu
t
5.6.
3R
evie
w O
utp
ut
6.R
ES
OU
RC
E M
AN
AG
EM
EN
T
6.1
Pro
visi
on
of
Res
ou
rces
6.2
Hu
man
Res
ou
rces
6.2.
1G
ener
al
6.2.
2C
ompe
tenc
e,
Aw
aren
ess
and
Trai
ning
IPE
C-P
QG
GM
P A
UD
IT G
UID
E F
OR
PH
AR
MA
CE
UT
ICA
L E
XC
IPIE
NT
S
CO
MM
EN
TS
GM
P S
EC
TIO
NIT
EM
Cop
yrig
ht©
200
7 T
he In
tern
atio
nal P
harm
aceu
tical
Exc
ipie
nts
Cou
ncil
and
Cop
yrig
ht©
200
7 P
harm
aceu
tical
Qua
lity
Gro
up2
•R
epor
ting
rela
tions
hip
of Q
ualit
y U
nit
and
Pro
duct
ion
(org
aniz
atio
n ch
arts
)•
Job
desc
riptio
ns•
Cla
rity
of Q
ualit
y U
nit a
utho
rity
and
resp
onsi
bilit
ies,
del
egat
ion
•B
atch
rel
ease
•P
erio
dic
conf
orm
ance
rep
orts
to to
pm
anag
emen
t
•Q
ualit
y sy
stem
com
mun
icat
ion
•To
p m
anag
emen
t not
ifica
tion
of q
ualit
ycr
itica
l iss
ues
•S
enio
r m
anag
emen
t qua
lity
syst
emre
view
•D
efin
ed
•R
esou
rces
and
impr
ovem
ents
id
entif
ied
•A
dequ
ate
reso
urce
s
•E
duca
tion,
trai
ning
exp
erie
nce
•C
onsu
ltant
qua
lific
atio
ns
•A
dequ
ate
trai
ning
exp
erie
nce
and
qual
ifica
tions
•Tr
aini
ng S
OP
•Tr
aini
ng p
rogr
am•
Trai
ner
qual
ifica
tions
•G
MP
trai
ning
rec
ords
•G
MP
trai
ning
freq
uenc
y•
Mea
sure
of t
rain
ing
effe
ctiv
enes
s•
Com
mun
icat
ing
chan
ging
reg
ulat
ions
6.2.
3P
erso
nn
el H
ygie
ne
6.3
Infr
astr
uct
ure
6.3.
1B
uild
ing
an
d F
acili
ties
6.3.
2E
qu
ipm
ent
6.3.
2.1
Eq
uip
men
t C
on
stru
ctio
n
6.3.
2.2
Eq
uip
men
t M
ain
ten
ance
6.3.
2.3
Co
mp
ute
r S
yste
ms
6.3.
3U
tilit
ies
6.3.
4W
ater
6.4
Wo
rk E
nvir
on
men
t
6.4.
1A
ir H
and
ling
IPE
C-P
QG
GM
P A
UD
IT G
UID
E F
OR
PH
AR
MA
CE
UT
ICA
L E
XC
IPIE
NT
S
CO
MM
EN
TS
GM
P S
EC
TIO
NIT
EM
Cop
yrig
ht©
200
7 T
he In
tern
atio
nal P
harm
aceu
tical
Exc
ipie
nts
Cou
ncil
and
Cop
yrig
ht©
200
7 P
harm
aceu
tical
Qua
lity
Gro
up3
•P
erso
nal h
ygie
ne tr
aini
ng•
Clo
thin
g•
Rep
ortin
g of
illn
ess
•Lo
ose
item
s lik
e je
wel
ry a
nd p
ens
•C
onsu
mpt
ion
of fo
od, b
ever
age,
and
toba
cco
prod
ucts
•A
cces
s co
ntro
ls
•S
pace
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onta
min
atio
n co
ntro
l•
Toxi
c pr
oduc
ts•
Env
ironm
enta
l con
trol
s •
Labo
rato
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cilit
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•S
tate
of r
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Mai
nten
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utdo
or e
quip
men
t
•C
onta
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urfa
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•Lu
bric
ants
,coo
lant
s et
c•
Des
ign
to m
inim
ize
cont
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atio
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•P
roce
dure
s•
Rec
ords
•H
and
over
/ ha
nd b
ack
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cces
s co
ntro
ls•
Cha
nge
cont
rols
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onsi
sten
t fun
ctio
n•
Bac
k up
, dis
aste
r re
cove
ry
•R
isk
of c
onta
min
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n
•S
peci
ficat
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/ bac
k flo
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ffect
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ecirc
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on
tro
lled
Env
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nm
ent
6.4.
3C
lean
ing
an
d S
anit
ary
Co
nd
itio
ns
6.4.
4 P
est
Co
ntr
ol
6.4.
5 L
igh
tin
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6.4.
5 D
rain
age
6.4.
5 W
ash
ing
an
d
Toile
t Fa
cilit
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7.P
RO
DU
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RE
AL
IZA
TIO
N
7.1
Pla
nn
ing
of
Pro
du
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Rea
lizat
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7.2
Cu
sto
mer
-rel
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Pro
cess
es
7.2.
1D
eter
min
atio
n o
f R
equ
irem
ents
Rel
ated
to
th
e P
rod
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7.2.
2R
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w o
f R
equ
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Rel
ated
to
th
e P
rod
uct
7.2.
3C
ust
om
er
Co
mm
un
icat
ion
7.3
Des
ign
an
d D
evel
op
men
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7.4
Pu
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IPE
C-P
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GM
P A
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ICA
L E
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Cop
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7 T
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tern
atio
nal P
harm
aceu
tical
Exc
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nts
Cou
ncil
and
Cop
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200
7 P
harm
aceu
tical
Qua
lity
Gro
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•R
equi
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•D
evia
tions
•A
ppro
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an•
Pro
cedu
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sch
edul
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te c
ontr
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f inf
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ontr
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ls•
Rec
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, rev
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of e
ffect
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ess
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dequ
ate
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dequ
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dequ
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faci
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s•
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Crit
ical
par
amet
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atch
or
cont
inuo
us•
Mul
ti pu
rpos
e•
Equ
ipm
ent &
line
s ID
•C
usto
mer
req
uire
men
ts•
Agr
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addi
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l req
uire
men
ts
•M
utua
lly a
gree
d sp
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catio
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•C
ontr
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of c
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R
equi
rem
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catio
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cus
tom
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of
sign
ifica
nt c
hang
es
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chno
logy
tran
sfer
7.4.
1P
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has
ing
Pro
cess
7.4.
2P
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has
ing
Info
rmat
ion
7.4.
3V
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icat
ion
of
Pu
rch
ased
Pro
du
ct
7.5
Pro
du
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n a
nd
S
ervi
ce P
rovi
sio
n
7.5.
1C
on
tro
l of
Pro
du
ctio
n
and
Ser
vice
Pro
visi
on
7.5.
1.1
Pro
du
ctio
n In
stru
ctio
ns
and
Rec
ord
s
7.5.
1.2
Eq
uip
men
t C
lean
ing
7.5.
1.3
Rec
over
y of
Sol
vent
s,
Mot
her
Liqu
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Sec
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200
7 T
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tern
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nal P
harm
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Exc
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Cou
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Cop
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7 P
harm
aceu
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Qua
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Gro
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cont
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App
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Aud
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sup
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Sel
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Follo
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actio
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Mat
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uppl
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Sup
plie
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tific
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sig
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chan
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roce
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s fo
r ap
prov
al a
nd r
elea
se•
Qua
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ampl
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proc
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stin
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catio
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Bul
k de
liver
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ontr
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d m
aste
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inst
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vabl
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uita
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deta
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edic
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or
cont
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for
ross
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Doc
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cle
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Sto
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nd s
ampl
ing
devi
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Con
tinuo
us p
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sses
, fre
quen
cy o
fcl
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ontr
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in p
lace
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bilit
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7.5.
1.4
In-P
roce
ss
Ble
nd
ing
/Mix
ing
7.5.
1.5
In-P
roce
ss C
on
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l
7.5.
1.6
Pac
kag
ing
an
d L
abel
ing
7.5.
1.7
Rec
ord
s o
f E
qu
ipm
ent
Use
7.5.
2V
alid
atio
n o
f P
roce
sses
fo
r P
rod
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ion
an
d
Ser
vice
Pro
visi
on
7.5.
3Id
enti
fica
tio
n a
nd
Tr
acea
bili
ty
7.5.
3.1
Trac
eab
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7.5.
3.2
Insp
ecti
on
& T
est
Sta
tus
7.5.
3.3
Lab
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C-P
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GM
P S
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Cop
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200
7 T
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tern
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nal P
harm
aceu
tical
Exc
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nts
Cou
ncil
and
Cop
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200
7 P
harm
aceu
tical
Qua
lity
Gro
up6
•B
lend
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proc
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Def
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Par
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Labe
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Mat
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Trac
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Con
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mat
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Iden
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con
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ID o
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Eva
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of r
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labe
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5P
rese
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of
Pro
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7.5.
5.1
Han
dlin
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tora
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an
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rese
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7.5.
5.2
Pac
kag
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Sys
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s
7.5.
5.3
Del
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d D
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tio
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7.6
Co
ntr
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f M
easu
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g a
nd
M
on
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evic
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8.M
EA
SU
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ME
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AN
ALY
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PR
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8.1
Gen
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8.2
Mo
nit
ori
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an
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rem
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8.2.
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Cop
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200
7 T
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tern
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nal P
harm
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Exc
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nts
Cou
ncil
and
Cop
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200
7 P
harm
aceu
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Qua
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Gro
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Pro
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8.2.
4M
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M
easu
rem
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of
Pro
du
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8.2.
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Lab
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Co
ntr
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8.2.
4.2
Fin
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stin
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Rel
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8.2.
4.3
Ou
t-o
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pec
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Test
Res
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s
8.2.
4.4
Ret
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amp
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8.2.
4.5
Cer
tifi
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s o
f A
nal
ysis
8.2.
4.6
Imp
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8.2.
4.7
Sta
bili
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8.2.
4.8
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Exc
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Cou
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Cop
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7 P
harm
aceu
tical
Qua
lity
Gro
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easu
rem
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f crit
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pro
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co
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tech
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Per
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Fit
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Com
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Per
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Rea
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Rel
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crit
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pro
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size
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Sta
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Con
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Sta
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and
para
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Co
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No
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rod
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8.3.
2R
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8.3.
3R
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Exc
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8.4
An
alys
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f D
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8.5
Imp
rove
men
t
8.5.
1C
on
tin
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Imp
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men
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8.5.
2C
orr
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8.5.
3P
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7 T
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harm
aceu
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Exc
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Cou
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Cop
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harm
aceu
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Qua
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