Quality Audit Report Notes
Quality Audit Report Notes
Quality Audit Report Notes
Selt to
t o
e valuat
evauate
a
inspection i alll apee
apec
puspose ObSet- a
ts çmp
Compkance
manutacturers
the
should be desghed
cet tnspectio) piammed
The
the
implamenla tibn
iplamenlatibn
pecoe
premsee fncuding peconalfadiies
Maintainance o buidigs Cquipmet
etoxa Startiog mateials mished prduct
q pmenl
productin pnCess Contms
> pcumeita ti
Santatin nyaiee
Caloratin ot nnmunit
Selt ipection tCa
Managemal Sheud appoint a el mpectien t e a
Constub epezts w hev Tespectire lds E
Constut
o
a as th Smp
he memberc h the teamb b e appointed
om fnse Out srde
e
otDina s an examp oChecx oh esetel
Donenl3
4eneral ities
Are Operatons
tersad wisio epoale G) delad
areas oacdea/uale sz
used So as to minímce
Are ckangek 0ome
ganed
C o n l a m n a t i op
eeAAs stores
gtores a materals,
Are
There Seperale
abels iniinis hed prduclt
Pockaaing
* Organrgatio G Mawagnsnt
inslnucted tn
Santation $ healta
re personal
perconal
earem enls
anmalM eConds
Are speci{fed t e s t repcated
Kept
Cadures
C e l t - nspection P
inspectHonAchedule
Cover all apec
Cover all aspec
Does
Does the Sel
p d u ct 6, $ 9
Claan, neot der4
Js Area
Toos o -ud to
C DOCumenl stanchods &guidelines
Gmp requlaions
Sualihy , eporls
epols
Aud?t
olbo tup
Orerous re Cods
doumensGepeH
Ouon
on
-Audteos
iaa
memoire s
Audit Chect Wst
C2 audt pla
ist to auditing
Check
(3
Olosevation
Audit
general Compay pmatiom
Management
Cmpa
Ogat abona infemnati
aina melwds
stot rendos
ut-sourcing Qevices
- DeasmerlalCndtiot pvactices
Shwature o ditec
Canplution dala
Audtte Dat
Piamme
er atte e inSpeotisn rpot Coreotine
acbonL noceD Can
udrt
phase O
inal
Repol
Actio actin Tepot
Comective
S i m p l e C o m e c b e
reest actiBa
ne OCe of
actin tten
infomuaton
ol lou P
meceivi auy
ack o
aity
udit
dit
Stacla
Dhas@s
Succescul
Auditi os)
Preparation