SURANCE UNITY

pHARMACEUTICAL UALITY AS
ALIFICATION
PR INC IPL ES OF CA LIB RATION, VALIDATION, QU
GE NE RA L
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. This Notes Is Slbmltlod
f.,¢'-'/
f . nd ard , the
1 ion is the act ivi ty of che cki ng, by com pariso n wit h a sta
' • Ca lib rat
tru me nt of any typ e.'
acc ura cy of a me asu rin g ins ng it in tq
me nt of the ins tru me nt to bri
• It ma y als o inc lud e adj ust
.
ali gnm ent wit h the sta nd ard

VALIDATION

d is the pro ces s by wh ich the

rel eva nce and I
• Th e val ida tio n of a tes t me tho rpo se.
ass ess ed for a par tic ula r pu
rel iab ilit y of the me tho d are d fro in its dev elo pm ent to its
evo lut ion of the me tho
• It is an .ess ent ial sta ge in the
for reg ula tor y pu rpo ses
j
acc ept anc e and app lic ati on

QUALIFICATION
"It is the act ion of pro vin g
an d do cu me nti ng tha t eq uip
me nt or an cil lar y
ua lly lea d to the
'I
,.
j
tem s are pro per ly ins tal led ; wo rk cor rec tly an d act
sys
exp ect e_d res ult s. "

ION:
IMPORTANCE OF VALIDAT
ce an d ~os t red:Uctio n.
s a gre at imp ort':111ce f(? r- Qu ali ty As ~u ran
Pal id ati on ass ure -an d Eff ect ive nes s
pro duc es pro du ct fit for int end ed use . Qu alit y; Saf ety
~ dat ion
to' pro duc t.
- ma y be des ign ed and bui l! in du ct. .
atio n i~ ke y ele me nt in ass um ing the qua lity of the pro
/ Va lid pro c~ s or ~y~ tem .
am ete rs con :tro ls de te~ ine d the ~al id~ tio n of an_Y
/ / Par d_u nng _the
ps to det erm ine the ~o rst cas e !111d ns~ s th~ t ma y an se
· ~ hel _
pro duc ts.
ma nuf act mj ng of the qua lity cau sed du rin g the pro ces s.
ps to inv e~t iga te ·the dev iati ons
~ Va lid atio n hel are ma de po ssi ble
the sys tem an d equ ipm ent
c.?. Deep stu dy and
ida
un
tio
der
n. ·
sta nd ing of
- ~ . '
/ ~ ue to the val the val ida tio ~.
reg ula tor y non -co mp lia nce 1s ~ e d aft er
:he ris k of the du ct tes tin g.
/
ces s req uir ed les s pro ces s con tro l and the fin ish ed pro
· • A val ida ted t2ro of pro ces ses , sys tem s
to bat ch var iati on is min imi zed du e to the val ida tio n
• Ba tch
and equ ipm ent .
t of the pro duc t.
• Re duc es the pro duc tio n cos mi nim ize d rew ork
rea ses the pro duc tio n of ma nuf act uri ng fac ilit y du e to the
• Inc '
·
~ d reje ctio n. I
s of the fai lur e of the batc!}eS.
/ / ~~ cre ase s the cha nce

I
/ -·
/ /As sur anc e of qua lity
_/ ✓ Tim e bou nd . / / .
✓ Pro ces s opt imi zat
ion
✓ Re duc tio n of qua lity cos t./ duc tiv ity . ·
✓ Mi nim al bat ch fai lur es,
imp rov·e d eff icie ntly and pro
✓ Re duc tio n in rej ect
ion s
✓ Inc rea sed ou tpu t
.
✓ Few er com pla int s abo ut
pro ces s rel ate d fai lur es.
in fin ish ed goo ds.
✓ Re duc ed tes tin g in pro ces s and
 ~ CEUTIC.-.L UAUTY ASSURANCE Ul'JITV

✓ More mpld nnd rellnble 1tnr1.-up or new equipment 's

✓ Eealer m nlnlennnce of cqulpmenl
✓ Improved employee awnrcncas or proccsACs.
✓ More mpld nu tomnUon.
✓ Oovt!mment rcgulollon (CompUnnee wllh vaJldotlon requlremenla la
nN:<eaanry for obtaining opprovnJ to mnnurocrure ond to Introduce new
produc ts)
OF VALIDATION:

• A writt.cn report on u,e outcome l.o be produced.

• Vnlid11tion over n period of time, e.g. nl lea.at three consecutive batches (full
producti? n acoJcl ln demonsltnte conaktency. ~
• ., Process, materioJs·ond e(tuipmcnt to prove cons istent yield of o produ,ct of lhe
/ ~uircd .qunlhy. . . ·
• MMufacturcrs to identify what validation work is needed
• Significnnt c hanges (facilities, equipment, processes) s hould be validated
• Risk assessment oppronch u sed 10 determine the scope and extent of validation -
needed.
~alytical Test Methods
• lnstrum'e nt Calibrations

/
.,•>~•-
~<>cc$S Utility Services

fau1pment
Material

/ ,,[a cili ties

/ ~ du_c t Design
y t :Jearung .
TYPES OF VALIDATION
VALIDATION :

• Validation mc,ans rectification or confi.rmatio',)

• Validation tan be defined as a procedure tba t demon stra tes thal a process under
st.andard condition s;s capa ble ·or consistently producing a product that meets the
established produc t specification s.
Typr I

Validation
_____
~major types or Validation
• • ,.

":"" Process validation

• Cleaning validation
~ Equipment validation
,# •

J_ .,...__ ___
,.._._c:::._,..~ - - ._:::;;,- ---• ---
.,__..::::-..==::-..=-.-:-..7=:.---::!=.::\:.- -.............

v-- Analytical method validatio

L
 UALITY ASS URANCE UN JTV
RMAC EUTICAL
OC ES S VALIDATION
As per FDA Nov .20 08 ,
ta f . sta ge thr oug hou t pro duc tion wh ich
th pro ces s des ign
'Th e coll ect ion. of da
. rom e ' lno r m-, t,+. ,
· en tly delivei-
. h

---
nti fic ev'1d th ces s · cap able of con sist
1s
bl
est a 1s es scie enc e at a pro ~
pro duc ts '

,,,,.
Sta ge- 1 PROCESS _DE SIG N _.,,,,

ION
Stage- 2 PR OC ESS QUALIFICAT

Sta ge- 3 CONTINUED PROC~

VERIFICATION

es of Pro ces s val ida tio n:

I
• Pro spe ctiv e Val ida tion ./ ol~ w . ..

• • ' • , . / -~~",;,i:.i,= .== ~ -

- • d o, u h ..Wlll«ln
II'-. . . . . ~~
• R etro spe ctiv:e Valid atio rl/ u.:r.
0
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How lo Dowf'lbd Ud 'H k POF "'"

Co ncu rre nt V8;1idation./

,,

•
• . eva lida tion .
_,/
AN ING VALIDATION
in a m ulti -
t the re is no cro s~ con tam ina tion
•Cle ani ng val ida tion ens ure s tha ina tion .
cl:1so pre ven ts mic rob ial con tam
pro:Y-1c t ma nuf act uri ng pla nt and ng app rop riat e
d, the equ ipm ent is cle ane d usi
• On ce a pro duc t is ma nuf act ure ent
b~i she d dur ing IQ of the equ ipm
/ e stablis h cle ani ng SO P'S esta
tio n
con sid ere d in cle ani ng val ida
Ty pes of con tam ina tio n to be
.J)
• Cro ss con tam ina tion ~
C

L ..J} • Microb ial con tam ina tion

san itizing ag~
• Co nta min ation by clea nin g or ·
• Co nta min atio n by oth er age n~
OUIPMENT VALID ATION
As per FDA. May 198 7,
exp ect ed
of pro vin g tha t any equ ipm ent wor ks cor rec tly and lea ds to the
- ~on
/ ;~v~ is egu ipm ent qua lifi cat ion .
sin ~e ste p a ctiv ity but ins tea d .r esu lt from :i;nany dis cr,e
te activities.
"~ s no t a

Ste pr. inv olv ed ..

Use r req uir em ent spe cifi cati pn
1. Des ign qua lifi cat ion , /
2. Ins tall atio n qu ali fic ati on V'
3. Op era tion al qu ali llc ati on s/
oY
4. Per for ma nce qu ali fic ati'6olU1 no! In 11Wng,
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nu Noi.1 1, IUbmltted by· Mr Bh11gh
 ~
UNI T V

PHARMACEUTICAL UALITY ASSURANCE

DES IGN INSTALLATION

OPE RA TIO NA L
PER FOR MA NC E
QU ALI FCA TIO N
~

3
QU ALI FIC ATI ON QU ALI FIC ATI ON
QUALTFICATION

• Wh ene ver the

• After ins tall atio n

~
• Bef ore • At doc um ent ed in s tru me nt is
ins tall atio n of • After ma jor cha nge s
pur cha sin g a use d
new or exi stin g e.g . rep air, upd ate s
new ins tru me nt e.g . dai ly
inst :rum en ts • At reg ula r inte rva ls

YTICAL ME TH OD VALIDATION
(ris k bas ed)
:,
~
cal pro ced ure
s use d to con firm tha t the ana lyti
• Me tho d val ida tion is the pro ces
tab le for its inte nde d use .
emp loy ed for a spe cifi c tes t_is sui
VA LI DA T~
TY PES OF PR OC ED UR ES TO BE
1. Acc ura cy/
___.-- ~
2. Pre cisi o~
3 . Rep eata bili ty_ _-/
4 . Rep rod uci bili ty____/
:""1
5. Spe cifi city /
6. Lin ear ity ~
7. Inte rme dia te pr ec i~
~
8. Qua lifi cati on lim it
9. Qu ant itat ion lim it/
1O.R obu stne ss
·
~
~
11. Rug ged nes s • ., "Solution.Pharmacy· believes In SHARI
NG not in selling . I
nd
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~tCT ¥Fc,' :.i~u~ ~C!n \;!,,'n•lagram ~
ACCURACY
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wee n the obs erv ed
7..~: :i~~~ ~r;tE ~~i:. 7:
I
acc ura cy of ana lyti cal me tho d refe rs to the ,cg sen ~s e~e nt bet ~
The .
er von ti a tru e one or r,ef eren ce one I
val ue and the val ue wh eth er is eith
PRECISON
es obt ain ed from a
~
tho d refe rs to the clo sen ess of val
The pre cisi on of an ana lyti cal me
ser ies of ves ts.
~
REPEATABILITY ~

,~
eat edl y by the sam e
the sam e sam ple is est ima ted rep
Rep eata bili ty is esta blis hed wh en
ana lys t usi ng sam e ana lyti cal me tho d within_ the sam e lab ora tor y usi
ng sam e I~
a sho rt per iod of tim e.
ins tru me nt and per for me d wit h in
LIMIT OF DE TEC TIO N
not nec ess arily I~
low est am oun t of ana lyte in a ~am ple tha t can be det ect ed but
The
qua ntit ate d, und er the sta ted exp
erim ent al con diti ons . I~
RU GG ED NE SS II ~
of the sam e sam ple
The deg ree of rep rod uci bili ty of tes
diti ons suc h
t res ults obt ain ed by the ana lys is
as diff ere nt lab ora tori es, diff ere nt ana lys
ts, diff ere nt ~f
und er a var iety of con es, diff ere nt ass ay
gen ts, diff ere nt ela pse d ass ay tim
1

ins tru me nts , diff ere nt lots of rea "---- •

tem per atu res , diff ere nt day s, etc.
"
"Solutlon4>hamiacy" believes In SHARI
NG not in selling .
cy In- ( 1) YouTube (2) Fac,,book- Group
Find solution pharma
and Page (3) lnstagram
/SOLUTIONpushpendra
J ..,.,_,

I
You'rube Link- https:/!www.youluba.com/c As_u_ _ _ _ ____J " I
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 UNJTV
PHARMACEUTICAL QUALITY ASSURANCE

VALIDATION MAST ER PLAN

• Valida tion master plan is also known as VMP ~

• It is key docum ent in GMP (Good ~anuf acturi ng Practi ce).._. -'
zation al
• It describ es the key elemen ts of the valida tion progra mme, organi
structu re of valida tion, schedu les and r~sppn sibiliti ~
h~
• It should describ e : "Why, What, Where , by whom , how and w I

Scope
• Reduce reworV
• Satisfa ctory inspe ctiony
• Helps in new d~g appr o~
.I
Conte nts of VMP
• Introdu ction
•
•
e

•
Method ology _ .-
Qualifi cation
Person nel
S C h e d U 1e
How to Download

Preven tative mainte nance

Notes ,n FDF ~om !;oMon
·so1ution-Pharmacy" believes In SHARING not In sellng.
Find solution pharmacy In- (1) YcuTube (2) Facebook-Gr oup and Page
YouTube Unk- httpo://WwW.you!Ube.com/c/SOLUTIONpushpencta .
Pharmacy Fao,book
This Notes Is submitted by- Mr Bhaghawan RK
Group
so
Using
lhat all studenls may gel bemfit al lhis
(3) lrutagram

a,rona vlru5
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• Chang e control i
•
•
Proced ure
Docum entatio n
I
• Append ices
@NTR OD~CT ION:
It include following details :
• A descrip tion of facility, premis es, Equipm en~ & it~ purpo st.,/
• Scope of valida tioy ·
• Policies on ~egula tory bodi,es like GMP, cGMP, Wlj.0-.

~etho dolog y:
• Predete rmined require ment to identif ying the standa rds.
ion
• Develo pment of the accept ance criteria that are used to judge the validat
• It is also involve planni ng and execut ion of docum ents such as protoc
ols, I
record s, report s, or 0th.e r.
• The std will involve three elemen ts
1. Regula tory and guidan ce docum ents
2. Nation al standa rds
3. Compa ny standa rds "Solution-Pharmacy" believes In SHARING not In sotlng.
I
yam
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ThisNotes Is s\brnlttod by- Mr Bhaghawnn RK ao that oil studenla may get beniflt
ot this corona vlru5 lod<dc>$l

• Include s all the aspect s of Design , procur ement , install ation, and
commi ssionin g proces s
ver all the
• It is import ant to ensure that the organiz ation is consis tent and'co
aspect of valida tion proces s for specifi c projec t. ·
·any inspec tion author ity.
• The validat ion structu re and organiz ation is clear to
of facility
• Design qualifi cation providi ng docum ented eviden ce that the design
and equipm ent meet the require ments of the user specif ication & GMP.

Y.:l
 UNIT V

PHARMACEUTICAL UALITY ASS URANCE

Per son nel:

th
on en gage d in each per s on resp on s ible for sup ervis in g e man ~fo ctur c
• Eac h pers
g prod uc t s h a ll h ave th e edu cati on,
Proc essin g, pac kagi ng, or hoid ing of a dru
ther e of en a ble th at pers o n to perf orm
train ing, and expe rien ce or a com bina tion
the a ssig ned func tion s"
✓ Prin cipl es for pers onn el requ
irem ents .
✓ Exp erie nce of pers onn el in hou se train ing repo rts, e tc.
nolln ~ ,., ,.,.._
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• E ssen ti
• Prep ared at' earl y stag e
whi ch are to be con side red duri ng
• A good plan con tain s all n eces sary features
rol of the proj ect.
exec utio n of plan and dete rmin es the cont
the VMP are not only awa re of the
• It ensu res that the pers onn el invo lved in
on targ ets.
engi neer ing targ ets, but also the vali dati
even tive Mai nten anc e:
anc e and ope rati on dep t.
• This is the resp onsi bilit y of site mai nten
the desi gn pha se, and doc ume ntat ion
• The activ ity sho uld be perf orm ed duri ng
on
requ ired shou ld be, incl ude d in requ isiti
Cha nge con trol :
irem ents for a set of proc edu res for
• This sect ion of VMP shou ld lay dow n requ
chan ge cont rol that cove r.
n, Com miss ioni ng
• The proj ect thro ugh desi gn, con stru ctio
occu r in both the proc ess and the
• The ongo ing chan ge that will inev itab ly
equ ipm ent and engi neer ing aspe cts.
Proc edur es:
in the proj ect desi gn, thro ugh to
• The se cove r engi neer ing stan dard ~ used
stan dard proc edu res (SOPs).
com miss ioni ng pha ses and the facil ities
Doc ume ntat ion:
ntat ion that shou ld be prod uced for the
This sect ion usua lly to iden tify the doc ume
proc essi ng like
1. Eng inee ring draw ing
nts
2. Equ ipm ent supp lier draw ing and doc ume
3. Fact ory acce ptan ce doc ume nt
4. IQ doc ume nts
5. OQ doc ume nts
6. PQ doc ume nts

I App end ices :

• The app end ices is mos tly used VMP to hold
and form ats that will be used in exec utio
the info rma tion of type of doc ume nts
n stag e.
•So1u1Jon-Pharmacy" bellevet In SHARIN G nol In selling
Facebook- Group and Page (3) tnstagram
Frnd sollAion ptia,mac y In- (1) YouTubo (2)
.be.com/clSOLVTIONPlJShpendra
• Vou'rlbe Link- https11www.youii 6ha Using Mobile h11ps.//youtu.be/nlZXKl2pASU
SollAion Phatmacy Facebook Group Using Lap!Dp http,1/youlll.be/cEliMAtOJ
HCM' ID Dowrvoad Notes !nPDF from,ubm,lll 'd by- Mr Bhaghawan RK so that all student, may get ben/111 at this ccrona virus lockdoen
Thi• Notes I•
\~~~~

~
~ PHA UALlTY ASSURANCE
UNlT V

~
~ 1. Calib ration shoul d be perfo rmed with at least two
stand ard buffer solutions that
span the range of pH value s to be meas ured.
~ 2. For gener al purpo ses buffe rs at pH 4 and pH 10 are
set
accep table.
the meter , readi ng equal to
• The pH meter has one contr ol (calib rate) to
~ the value of the first stand ard buffe r
e r re~di ng to the
• A secon d contr ol (slope ) which i·s used to adjus t. the met.
~ value of the secon d buffer . · ·
• A third contr ol allow s the temp eratu re to be set.
~ . -
c7 on of pH Mete r Proce dure: I
~ L Tum on the pH m eter on an4 wa sh with distil led water .

-~
Imme rse the electrode in nH 4 tiuffe r 'solut ion
'
d press 'stand ardiz e' butto n after
the rea mg'ha s been s tabilized -
II
;

Wash the electr ode with distill ed water and gently dry with
tissue .
!,
on/
Repea t the proce dure for the pH 7 and pH 10 buffe r soluti

METE R
QUALIFICATION OF UV - VISIB LE SPEC TROP HOTO
UV-Visible spect rosco py is conce rned with ultra violet
and visibl e r egion s which range s
from 200-7 80nm , . "Solution-Pharmacy" believes In SHARING not in selling.
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This Notes is submitted by- Mr Bhaghawan RK so that alt students

QUALIFICATION: i
plies \.vith some
Quali ficatio n is an act or proce ss to assur e some thing com
I
• I
condi tions, stand ard or specif ic requi remen ts. I
DQ
l
~
~
PQ Quali ficati on IQ

OQ
I
s that the plant desig n
• Desig n Qual ificat ion: Docu men ted evid ence which show
agree s with the desig n specif ications of the custo mer.
all parts of equip ment
• Insta llatio n Qual ificat ion: Writte n evide nce is given that
ase specif icatio ns.
are instal led accor ding to the equ ipme nt suppl ier's and purch
show s that all parts of
• Oper ation al quali ficati on: Docu mente d eviden ce which
the plant and equ ipme nt work withi n param eters.
nce that all parts of a
• Perfo rman ce Quali ficati on: Provi des docu mente d evide
qualit y unde r condi tions
plant and other p roces ses produ ce produ cts of specif ied
of n ormal produ ction fo r a longe r period of time.
 UN ITV

PHA RM AC EUT ICA L UALITY ASS UR ANC E

CA TIO N
PE RF OR MA NC E QU AL IFI
0 Wa vel eng th acc ura cy
the wa vel eng th
It is def ine d as the dev iati on of
d and em iss ion ban d
rea din g at an abs orp tio n ban
d.
fro m the wa vel eng th of the ban
ge (20 0-3 80 nm ) and
Ac cep tan ce: ± nm in W ran
nm )
± nm in vis ible ran ge (38 0-8 00
·th ·111 ±0 •5 nm
eat ed sca n of the sam e pea k sho uld be WI
Th ree rep

Str ay lig ht
tha t is ou t sid e the
ay ligh t is def ine d as the det ect ed lig ht of any wa vel eng th
Str
sel ect ed.
han d wid th of the wa vel eng th d be les s tha n
ce: the tra nsm itta nce of the sol uti on in a ·1c m cel l Sh oul
Ac cep tan
sho uld be gre ate r tha n 2
0.0 I or the abs orb anc e val ue

ha nd wid th.
of the UV -VI S spe ctr om ete r is rel ate d to its spe ctr al
Th e res olu tio n s on the shi t
ban d wid th the fin er the res olu tio n. Th e SB W dep end
Th e sm alle r the
er of the mo noc hro ma tor .
wid th and the dis per siv e pow
anc e at 266 nm
tan ce: Th e rat io of the abs orb anc e at 269 nm and abs orb
Ac cep
sho uld be gre ate r tha n 1.5 .

orb anc e
No ise
rem ent aff ect s the acc ura cy at the bo th end of the abs
No ise is the me asu cy of the me asu rem ent
le. Ph oto n noi se fro m the lig ht sou rce aff ect s the acc ura
sca
lea ds to low abs orb cµi ce.
sho uld be les s tha n 0.0 01 AU
Ac cep tan ce: Th e RM S noi se

Ba sel ine fla tne ss ins tru me nt to nor ma lise

tra tes tha t the abi lity of the
Th e fla t bas elin e tes t dem on~ ent wa vel eng th
ens ity me asu rem ent and the spe ctr al ou tpu t at dif fer
the lig ht int
thr oug hou t the spe ctr al ran ge.
1 AU
ent is· typ ica lly les s tha n 0.0
~cc ept an ce: Th e me asu rem

6>• Sta bil ity

int ens ity is a fun cti on of the lam p age , tem per atu re flu ctu
ati on and
Th e lam p to err ors in th·e val ue of
ent . Th ese cha ng es can lea d
wa vel eng th of the me asu rem
ext end eq per iod of tim e.
the me asu rem ent s, ove r an

is les s tha n 0.0 02A U / hr

Ac cep tan ce: Th e def lec tio n
in SHARING not In selling
. ·so1ulion-Pharmacy" believes (3) lnstagram
~ace book -Gro rfc and Page
Flfld solu tion ~~ rn-(1) YouT

How to Download Notes in PDF from

Phatria':;
Solution f ~ ~tt:'ll.aPIO ma:
· ;:;"J! ;OLU T ONts hpen dra
ge~~ r:111 ~~~~ .Y;,~ npo~
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~~~~ httpsJ/you1u.be/ntzXK12pA5U
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This
 i

UNJTV
PHARMACEUTICAL UALITY ASSURANCE

Pho tom etr ic acc ura cy wee n the

d by com par ing the di.fferen_ce bet
Pho tom etri c acc ura cy is det erm ine val ue.
ren ce ma teri al and the esta blis hed
me asu red abs orb anc e of the refe
pot assium
rem ent s of the 0.0 06% w/v of the
Acc ept anc e: Six rep lica te me asu tha n 0.5% RSD.
313 and 350 run sho uld be less
dic hro mat e solu tion at 235 , 257 ,
,r,,.J:';:-.::::0~".,.,,~"'..... ,_
- =7-='='==::i==-~
A - I l l ~ "WI& ...

~-~ .....__ ...,_

._...,. ..
"'~__ _ ,,.,.
...... .. - ::=
,:e:
Lin ear ity hig h
rem ent is lim ited by stra y ligh t at
The line ar dyn ami c ran ge of me asu the qua ntif ica tion of
bs or ban ce. The acc ura cy of
abs orb anc e and by noi se at low a
on and line arit y of the
the sam ple dep end s on the pre cisi
Me asu rem ent s .
~ 0.9 99
J ~ tan ce : Cor rela tion coe ffic ient r

L METHOD VALIDATION
-~ RAL PRINCIPLES OF ANALYTICA
cal pro cedure
use d to con firm tha t the ana lyti
• Me tho d validat ion is the pro ces s
abl e for its inte nde d use .
emp loye d for a spe cific t~st is suit iab ilit y and a
can be use d to Jud ge the qua lity , rel

I
• Res ults from me tho d val ida tion
.
con sist enc y of ana lyti cal res ults
goo d ana lyti cal pra ctic e.
• It is an inte gra l par t of any
As per FDA-gu ide line s h deg ree o f
I
•
idat ion is esta blis hin g doc um ent ed evid enc e wh ich pro vid es a hig
• Val duc t me etin g its
ass ura nce tha t a spe cifi c pro ces
s will con sist ent ly pro duc e a pro
pre -de ter min ed spe cifi cat ion s
and qua lity att rib ute s.
d.
the cha rac teri stic s to be con sid ere
• Guideli ne pre sen ts info rma tion on le for its inte nde d
aly tica l pro ced ure is sui tab
• Man ufa ctu rers to dem ons trat e -an I
pu rpo se.
All ana lyti cal me tho ds sho uld
be val ida ted - wh eth er

I
•
they ind icat e stab ility or not . t wh en
ida ted by R&D bef ore bei ng tran sfe rred to the qua lity con trol uni
• Val
app rop riat e ical sam ple s wil l
All ana lyti cal me tho ds inte nde
d to be use d for ana lys ing any clin i
•
nee d to be val ida ted .
·so1uUoo-Pharmacy' believes In SHARI
NG not In soiling.
e 12) Focebook-Group and Page (3)
lnsIagram
1
Flfld solutlon pharmacy lr>-(1) YouTuboulube.com/c/S0Ll/T l0Npushpendn, XKi2pASU
YouTub e Unk- https1/ www.y
Using Laptop https://youru.be/cE5M AlOJ6hs Using Mobile hltps //youlU.belnlZ
Solution Pharmacy Facebook Group corona virus locl<doen
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I
This Notes Is
f)
 ~ ~

3
UNlTV

PHAR MACE UTICA L UALIT Y ASSURANCE

PHARMACEUTICAL WA RE H~

INTRODUCTION :
~ Main tainin g prope r storag e condi tion for pharm aceut ical produ cts a
nd ~
~
effica cy.
_para medic al is vital to ensur e their qualit y, safety and
ed raw mater ials and
....Y'F actory store s will invar iably be receiv ing duly a pprov

~
· ·
ycka ging mater ials from third party .
ial, handl ing o~ raw & packa ging.
/ I\ suitab ~e space is provi aed to-raw mater
pharm aceut icals.
~
inclu ding packa ging of
mater ials requi red for manu factu ring,
JP!s spa~e is !mow n as
war9 Ji~us ,.'
/ H lS a part of pharm aceut ical comp any.
.
~
~
PURP OSE:
and medic al equip ment
• To enabl e the fastes t and cheap est traµs port of drugs

•
from suppl iers to benef iciari es.
There are mainl y 3 stage s:
"
~
~
✓ Purpo se Qf pharm a~eut ical produ ~ .,.
✓ Stora ge of or~er ed p roduc ts__;-.-<}
✓ Distr ibutio n o( st9ck ed pro d~-- ----- ~
VARI OUS AREA S OF WAR E HOUSING:
~

L JmCE IVIN G AREA: ' .

. -Ji
~
ing.
/' Inclu des mitia l ,inspe ction , clean ing and weigh t check
. - - ·
PLING AREA
. 'With adequ ate facilit ies to preve
3 . foTORAGE' AREA . _., . · -
nt cross
.
conta mina tion
, ~
_./ . Inclu ding specif ic storag e like air condi tion room s, cold
· ·
room s,
~
4.
dou ehenµ cal stora ge_room
CTED MATE RIAL S
- Destr oy or reten ted ~nsu itable
. ~ •
I
- ~
~
~ . DISP ENSI NGA REA
With adequ ate facili ties to precl ude cross conta mina tion durin g
dispe nsing

ORGANISATION CHAR T/
~
'
'·
~
~
WAR EHOU SE
MANAGER

~
I
~ ~
WAR EHOU SE ~
WAR EHOU S~
OFFI CER /
I
INFO RMA TION OFFI CER .__,
~
~~
"So~N1m1cy" 1>11-YH In SHARING not ~ 11an9.

CLEANER
I ~v.:!.~:,.mm.~ t=:.ft:~r:~dts1~=:=21.~• •'fMI 1
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Howtu ~
,

-+ DAY
LABORERS
""--:
~
~
~
 UNITV
PHARMACEUTICAL UALITY ASSURANCE
DESIGN:

PRINCIPLE: Premises must be located, Designed , construc ted, adapted., and maintain ed
to suit the operation to be carried out.

LAYouf OF THE PHARMACEUTICAL WAREHOUSE:

/
✓
I ADMINISTRATIVE AREA I
AREA FOR PREPARATION
OFGOODS .
I GOODS. RECEIPT AREA ·I

STORE
~

w
I PERFUSIO N SOLUTION I 0 I REFRIGE RATOR I
R !
FLAMMABLE PRODUCT S I NARCOTICS AND
I
I
K
CONTOLLED
s
I SYRUPS I H ,.
I
TABLETS AND REl>ATED
-
0
p
I INGECTION
Ii
MATERIALS
I EXTERNAL USE I
I QUARANTINE AREA
'
I
I
MANAGEME NT OF
EXPIRED MEDICINES
I
I
I MEDI~A L EQ~ME NT
I I
PHARMACEUTICAL WAREHOUSE:

✓ The layout and design of premises must aim to minimize the risk of erro~s and
permit effective cleaning and maintena nce in order to avoid cross-co ntamina1 tion
buildup of dust or dirt, and in general, ·any adverse effect on t4e quality of
.,.,,pfuduc t ,. ·
--4 Where dust is generate d (e.g., during sampling , weighing , mixing and processi ng
operation s, pac1rnging of powder) measure s should be taken to avoid cross-
contamin ation and facilitate cleanin g/ ,,. ~
✓ ~ mises should be ,situated in an environm ent in_which the mini.J.µum _risk of any
_/1/°~ontaminat,i.on of m~terials or products .
/✓ Premises used for the manufac ture of finished products should be suitably
designed and construc ted to facilitate good sanitati9 n '·
✓ Premises should be careful maintain ed, and ~t 'should be ensured that repair and
/ ~tenan ce operation s do not C!3-Uses any hazards to the quality of products
. / ::~~ses should be cleaned and where applicabl e, disinf~ct ed accordin g to
detailed written procedur es, records should be maintain ed,
✓ ~ectrica l supply, lighting, temperat ure, humidity 'a nd ventilatio n should be
,, appropri ate and such that they do not adversely affect, directly or indirectly ,
/ either the pharmac eutical products during their manufac ture and storage, or the
accurate functioni ng of equipme nt
'Solution-Pharmacy" believe, In SHARING not In sellng.
Ftnd sol~f.~':f,l.~)~~== -oW'/ro~~ag• (3) lnstagrum
Using Laptop hllpS°J/youtu.be /cE5MA=Using Mot>tlo hlll)s1/youtu.be/nlzXKl2pA5U
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- ~ 1 Ttis Notes is slbmitted by- Mr Bh~Nan RK so that au students may get benlftt at W• oorono virus lOCl<doen
 UNITV
... ]
PHARM ACEUT ICAL . UALllY ASSUR ANCE
i_rnum protec tion
ed so as to affo rd max d b tanda rd
✓ Premi ses s h ou ld be design ed and equipp
e a
8
again st the entry of insect s, bird s or other anima ls. There shoul
d
proce dure to preve nt from roden t and pest contro l person ne1·

~
l flow of mater ials an
✓ Premi ses should be design ed to en sure the logica
RIAL AND PEOPLE FLOW:
MAr e
shipm ent of goods
Arriva l of goods , Entra nce for visitor s, Entra nce for worke rs,

~
lnto 111111
QC Officu
Oo•111ng ~
~
1---- --Sl ,l, fll\1
f~'1, f:011d I t

:arradt-r ~
r ••
.J
ll 1t•1als
.,r
,~,.,. .
Pad agU\g Wr1 fh 1r ,
~
P_10ttU IQf .Y:lhJ\t
: t ~
~
I - Jr-i • Wachir,
I I Shop
~
tJ
--
u.11 Lie, antl Semee~ Wasre n eat:utn t'
~
~
GENERAL GUIDE LINES:
~
1. Mater ials receiv ed again st specif ic suppl y device s I
n)
2. Each such consig nmen t have writte n docum ents (delivery Chela ~
3 . All mater ials receiv ed by respon sible. perso ns I
4 . Mater ials to be check ed for cleanl iness and packa ge integr ity
5. Dama ged conta mer separa ted and report ing imme diatel y ~
6 . Check for prope r conta mer labeli ng
i.e., status of mater ials-U NDER TEST, ~
~=:=-=;;.:::::::::::..._.,:_~======--====.:_-A waitin g for APPROVAL ~
OD WARE HOUS ING PRACTICE:

• .,$actory stock which shoul d be receiv ed with prope r docum

ep.ts detail ing the ~
_.,,-./ name s of produ ct, the batch numb er, the numb er of unit~
batch, the date of dispat ch and the· qualit y contro l -statu s of the
of jinaj_ packs of ea ch
batch es ~
• The ·stotk contro l system must be such that only passe d ba,tch
~s of produ cts are
~se to en.a ble quick
---;
_.,.,.----issued for distrib ution. Stock s shoul d be stored , pro<iu ct
identi ficatio n and contro l of stock movem ent. Stock s shoul d theref
ore be racked
~
and stored in a mann er that earlie r stocks are more early acces sible than the later
-
-
~
,
ones.
as to minim ize the
/ 2 e pickin g and assem bling areas shoul d be so arrang ed
distan ce travel led by wareh oused opera tors. Pickin g stock s shoul d b e locate d on
identi fy the
~
shelve s at conve nient heigh ts and with prope r labels which clearly
Produc ts
·Sotu1Jorw'hannacy" beUeves in SHARING not in seU1ng.
Find solution pharmacy in- (1) YouTube (Z) Faceb00k• Grol4> ond Page (3)
lnstagram ~
~
YouTube Link- https:/Jwww.youtube.com/c/SOLUTION~pendr a
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~
~
~
~ UNITV

~
PHARMACEUTICAL UALITY ASSURANCE
quant ities and identities of
• Assem bled produ cts shou ld be check ed for accur acy of
41 produ cts order ed. Batch detail s shoul d be recor ded in relev
• Finish ed produ ct shoul d be packe d in the conta iners
ant docum ents
and dispa tched for the

~ transp ortati on.

• The unit produ ct packs shoul d be not conta mina ted
by other produ cts. Vehic le&

t which carry the final packa ged stock s of produ cts shoul
1. They are clear, dry and suffic iently prote cted
d be so select ed that-
from rain and other

~ weath er factor s
2. They are free from infest ation
te the produ cts.
,l) 3. They do not give off stron g odors which may conta mina
they carry
4. They are suitab le to withs tand the weigh t of the load
~ LES FOR WAREHOUSING:
I ...-,Syst emic storag e of the delive red goods . ·
~ ~ s e air circul ation and prote ction again st roden ts
s walls .
3. Keepi ng a space at l~ast 50cm betwe en the rows of pellet
'u . ~ rovid ing each produ ct have only" one specif ic pl~ce
.
there
...5<-0n shelv es clear labeli ng of_proq.u cts shoul d be
~ _§.,.---Kdeq~ate space shoul d be provi ded for eacti goods .
-i>rovid~ separ ate stoke card for each produ cts.
~ /
Y.Ail boxes in stock sboul d be closed
Sk' Flamm able produ cts shoul d stored in separ ate
place
t?1>
CHARACTERS OF GOOD WAREHOUSE:
~ ~op erly clean ed
~ Good prese rvatio n of drugs and equip
ments
~ v ide safety for staff and stock ed goods
~ t rol of air, light, humi dity and temp eratu re
i
- • .Jrod ucts to be purch ased accor ding to needs J
/ Order the destru ction of unsui table produ cts I
• Prom ote ration al use of pharm aceut ical produ cts I
THE WARE HOUSE STAF FS: I
1. T~ respo nsibl e phar maci st and his dutie s
\

i
ouse
-------- • Good s mana geme nt of the stock of the wareh '
• Good prese rvatio n of drugs and equip ment s
• Safety of stored goods
!
I
y he ware house keepe r and his dutie s
• Recep tion of suppl ies
• Stora ge of stock s of goods
ct in the stock card.
• Recor ding of every IN and OUT move ment of the produ
• Issue of produ cts durin g manu factu ring.
3 . The ware house work ers and his dutie s
g of goods which are
• Hand ling opera tions includ es the carry ing and movin
intend ed for storag e, shipm ent and sale
and main tain
• The wareh ouse staffs helps in receiv es and issue goods
inven tory
4. The clean er and his dutie s
• Ensu re clean liness of prem ises and equip ment
5. The secu. dty guard and his dutie s
• He is respo nsible for ensur ine: suoer vision and secur ity of the wareh ouse •
·sotution.f'tlarmacy" bblleve• lr1'sHARING not In selling • Page (3) lnstagmm
end
Fnd solution pharmacy lo- (1) You Tube (2) Facebook- OroupIONpu,hpe ndra
Youlube Link• hUpsJ/www ,youtube.com/c/SOLVT
Using Laptop J
hnps- tyoutu.ba/cE 5MA{OJ6hl Using Mobile hllps /tyoutubahltzXKl2pA5U
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Is submitted • Mr Bha hawen
This Notes
 ~

~
UNIT V
PHARMACEUTICAL UALITY ASSU RANC E

STO RAG E O - - WAN D PACKAGING MAT

ERIALS:

rage cond ition s- spec ial stora ge area with cont

rolle d temp eratu re, hum idity
:,
and store d off from the floor
✓ Bott les, vials , amp oule s, tins, tube s shou
do not cont amin ated by extra neou s matt er·
✓ Prin te,d pack agin g mate rial also store
ld be store d in a man ner that they

d prop erly
✓ Prin ted mate rials such as label s, prin ted
s~ou ld kept in stora ge cup'b oard s .-
film s/fc"5i ls/la mina tes, carto ns
3
:j
mate rials
✓ Prev entin g mix up of prin ted an1d non- print ed
✓ Phys ical segr egat ion of prin ted and
label ed cont aine rs shou ld be mad e ~
✓ Spec ial prec autio ns is need ed for
the stora ge of-pa ckag ing label ling
~
cont rolle d prod ucts
✓ Appr opria te stora ge cond ition to

HANDLING & ISSU E- RAW MATERIALS:

be prov ided
,~
• Atte ntion to be mad e for- prev ent cros s cont
amin ation , heal th of pers onne l ~
d prop erly, mate rials that supp ort
hand ling mate rials , cont aine rs shou ld _be close
micr obia l grow th are hand led caref ully. e.g. agar ~
~
on
• Mate rials issu ed only agai nst auth orize d pers
mask s, etc. shou ld be used to avoid
• Pers onne l prote ctive devi ces like glove s, face
m shou ld be prov ided to such away
heal th haza rds. Adeq uate dust extra ction syste
fine dust as to prev ent cros s-co ntam inati on.
~
~
✓ Pack agin g mate rials issue d to prod
uctio n only agai nst pack agin g mate rials
orde r
✓ Care shou ld mad e to chec k for only
✓ Unli ke raw mate rials , exac t quan
right pack agin g mate rials to be issue d
tity of pack agin g mate rials to be issue d ~
✓ Unu sed pack agin g mate rials retur
by auth orize d docu men ts.
ned to the ware hous e & will acco mpa nied
~
~
A'~z ·aoU SING OF FINI SHE D PRO DUC TS:

•
•
For avoi ding dete rior ation , spoi lage or brea
R~ em ent s: -
kage
~
•
prod ucts- cold stora ge area have
~
/ ... ~afe , orde rly and disp atch of all
acki ng and shelv ing syste m
temp eratu re mon itori ng and reco rding devi ces-r

. •
shou ld have good mec nani cal stren gth
~ed ure s:
· ~
men tatio n (nam batc h
e,
/ ... Stoc k recei ved from facto ry with prop er docu
. ½
~.
num ber, date of disp atch )
~
r test "mu st be quar antin ed and
✓ Finis hed prod ucts whic h are- unde
segr egat ed from -pas sed stock s"
✓ Stoc k shou ld be store d prod uct
wise to enab le quic k iden tifica tion and
cont rolle d stoc k mov eme nt
✓ ~toc k rotat ion shou ld be on- first
in, first out basis . ~
W ~ I N G OF RET URN ED GOO DS:
.
~
ion with qual ity cont rolle d man ager
• Stoc ks shou ld be carry out only cons ultat
• Retu rned good s mus t be isola ted on rece ipt,
clear ly iden tified and reco rds ~
rega rding reas on for the retu rn
• QC man ager shou ld exam ine whe ther thes
e good s are repro cess ed or destr oyed '--.
~
~
'-- :
 UNIT Y
PHARMACEUTICAL UALITY ASSURANCE
rding the instr uctio n of QC man ager
• Repr oces sing of retur ned shou ld be done acco
~-= .:.m -S :~~ - .
SANITATION: ,.... .. a.... ..~,: .':" '-=: ~-S .~~. Ji;; f:~, _..., ...~
e_dure for
. s shou ld be avail able. Inclu ~ing cle ~g proc
• ./4'"n tt~n sanit atio~ prog ram
wate r, mstr uctio n for hygJ.ene
/ pr~n uses and equi pme nt, a qual ity stan dard for to heal th,
instr uctio n relat ed
when man ufac turin g and hand ling good s, and
onne l and the disp osal proc edur e for wast e
hygie nic prac tices , and cloth ing of pers
mate rials and unus able resid ues
shou ld not be perm itted in
• Eatin g, smok ing, and unhy gien ic prac tices
man ufac turin g area
suita ble rode nti_c ides, insec ticid es,
• Ther e shall be writt en proc edur es for use of
sanit izing agen ts.
fung icide s, fume ngat ing agen ts and clean ing and
ding equi pme nt and mate rials
• Clea ning proc edur e shou ld be followed, inclu I

j
TANACE:
.
g, pack ing, or hold ing of drug
'

I
~ y build ing used in man ufac ture, proc essin
/

~
prod uct shall be main taine d in
~ - "
a·goo d state of repa ir
eteri orati on of build ing not only pres ents a poor
act on prod uct qual ity
imag e of facili
·
ty, it can also l
/2 cks an~ hole s in \Valls, floor s or ceilin as can prov
dirt or micr o rgaru sms
• They can also hind er clean
,
ing and sanit
·
ation
ides acce ss for · ·serts , bird s, •

, there by incre asin g pqte ntial for

cross-con tami natio n or micr obia l mult iplic ation
rd for peop le or even dislo dge mate rials
~ r ~rac ks can also b~~a use a safet y haza
~- . · .

e signi fican t dam age to mate rials and

• The ingre ss of wate r from roof leak s can caus
fires and resu lts in dam age to basi c
equi pmen t, give raise to elect rical failu res and
struc ture of the build ing
build ings prov ide read y acce ss to
• Addi tiona lly, hole s in the roof or near the top
with in the build ing.
birds , whic h may then be enco urag ed to nest i
i
j
~~ ~ec ord s shou ld be in place :
r m g r • Rece iving good s l
• Issui ng good s
• Train ing
;
• Mon itorin g temp eratu re and hum idity
• Clea ning oper ation
• Pest cont rol
• Calib ratio n
• Prev entat ive main tena nce
• Reca ll ·
• Com plain ts
• Inve ntory
• Log of sign ature

•solution-Pharmacy" believes In SHARING not In selling.

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Pharmacy Facebook
Mr BhaghaWen RK so that ell students may get benlnt
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1
 UNIT Y
PHARMACEUTICAL UALI TY ASSU RANC E
STO CK MAN AGE MEN T:
,,,-
~ :
• To ensu re cont inuit y of supp lies
• To avoid over s t o c ~ ·

ISSt:Jm1G OF MAT ERIA LS:

on the basi s of FCFO (Firs t Com e
• Store shou ld issue raw and pack ing mate rials
ent of mate rials shou ld enter ed
First Out) basis . Entr y and exit of every cons ignm
on the stoc k card
, the oper ation shou ld be
• While issui ng haza rdou s and explo sive mate rials
supe rvise d to prev ent any mist akes .

proc edur es
• Each ware hous es will have to estab lish oper ating
ities
• They mus t be clear ly defin ed for eacJi stage activ
Dire ct purc hase from raw mate rials man ufac tures
•
• Purc hase via Head quar ters
,, ,-; • Rece ption of local and impo rted orde rs
• Unpa ckin g, label ing, and stora ge of prod ucts
• Com pute rized stoc k man agem ents
• Prep arati ons of an orde rs for deliv ery
• Retu rns of drug s
• Managell?-ents of eA"Pired drug s
• Safe ty and clean lines s of prem ises.
·sorution-f'harmacy" beliews in SHARING not in selling.
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How 11> ll0wr1oad Notes ii PDF from Solution Phannacy all sllldents may get benifit at this
Tiis Notes is SlbmJtled by· Mr Bhaghawan RK so 1hal