PROCESSVALI DATI ON

ProcessVal idat i
oni st hemosti mpor tantandr ecogni sedpar amet [Link] equir
ement
ofprocessv ali
dat ionappear soft hequal itysy stem (QS)r egulat i
[Link] i
tysystem
i
st oconsi stent lypr oducepr oduct sthatar ef itf ortheirintendeduse.
Processv alidat ioni sakeyel ementi nassur ingt hatt hesepr i
ncipl esandgoalar emet .The
processv al idationi sst andar dizationoft hev al i
dationdocument st hatmustbesubmi tt
edwi th
thesubmi ssi onf i
lef ormar ket i
ngaut hor [Link] ocessv ali
dat i
oni si ntendedt oassist
manuf actur ersi nunder st
andi ngqual i
tymanagementsy stem ( QMS)r equi r
ement sconcer ning
process v al idation and has gener alappl icabi l
i
tyt o manuf acturing pr [Link] di
ng t o
FDA,assuranceofpr oductqual it
yi sder ivedf r
om car efulandsy stemi cat tentiont oanumberof
i
mpor tancef act ors, including: selectionofqual ityprocesst hroughi n-pr ocessandend- product
testi
ng.
PROCESSVALI DATI ONDEFI NI TION
Vali
dationmeansdemonst r
ation,bypr ovisionofobj ecti
v eev i
dencet hatconsi stentlymeet sits
predetermi ned r equi rement s.I ti s,t heref ore,an el ementoft he qual it
yassur ance pr ogram
associatedwi t
hapar t i
cul
arpr oductorpr ocess.“ Pr ocessv ali
dat i
oni sadocument edpr ogram
whichpr ovidesahi gherdegr eeofassur ancet hataspeci fi
cpr ocesswi llproduceapr oduct
meet i
ngi tspr edet er minedspeci fi
cat i
ons& qual i
tyat tributes. ”
Thebasi cpr inciplesofqual it
y
assurancehav east heirgoal thepr oduct i
onofpr oduct sthatar efitfort heirintendeduse.
 Dr ugEf ficacy
 Comput ersy stem Out put
 Saf et yofmedi caldev i
ce
 Ef f ect i
v enessofst eril
izer
 Abi lityofmanuf acturingt heaccept ablepr oduct

FDA i ssuedanot iceannounci ngt heav ail

abi l
ityofagui danceent it
ledGui delineonGener al
Principl esofPr ocessVal i
dat ion( t
he1987gui dance) .Si ncet hen,wehav eobt ainedaddi ti
onal
exper iencet hr oughourr egul at oryov ersightt hatal l
owsust oupdat eourr ecommendat i
onst o
i
ndust ryont hi st opi [Link] sr ev isedgui danceconv eysFDA’ scur rentthinkingonpr ocessv ali
dation
and i sconsi stentwi th basi cpr i
nciplesf i
rsti ntroduced i nt he 1987 gui [Link] evised
guidanceal sopr ov idesr ecommendat i
onst hatr eflectsomeoft hegoal sofFDA’ si ni
tiati
ve
ent i
tl
ed “ Phar maceut icals. CGMPsf ort he21stCent ury― A Ri sk-Based Appr oach, ”
par t
icul arlywi thr egar dt ot heuseoft echnol ogical adv ancesi nphar maceut i
cal
manuf actur ing,aswel lasi mpl ement ationofmoder nr iskmanagementandqual itysystem t ools
andconcept [Link] sr ev i
sedgui dancer eplacest he1987gui dance.
FDAhast heaut hor ityandr esponsi bili
tyt oinspectandev aluatepr ocessv ali
dationper formedby
manuf actur er s.
The CGMP r egul at i
ons f orv al i
dati
ng phar maceut i
cal( drug)manuf act ur
ing requi r
et hatdr ug
product sbepr oduce wi t
hahi ghdegr eeofassur anceofmeet ingall t
heat t
ri
but estheyar e
i
nt endedt opossess.
PRI NCI PLEFORPROCESSVALI DATI ON
Thebasi cpr inci plef orv ali
dat ionmaybe
statedasf ollows:
[Link] lationQual ifi
cat i
on( IQ) :
Thepr ocessorequi pmentmeet sall
speci ficat i
ons,i si nst alledcor rectl
y,andal lrequiredcomponent sanddocument ationneededf or
cont i
nuedoper ationar einstalledandi npl ace.
IQconsi der ationsar e:
•Desi gnf eat ur esofequi pment( material ofconst ructi
oncl eanabi li
ty.
)
•EquipmentI nst allationcondi ti
ons( wi ri
ng, ut
ili
ty ,
funct ionalit
y,et c.
)
•Calibr ation, pr ev ent at ivemai ntenance, cleaningschedul es.
•Safet yf eat ur es.
•Suppl ierdocument at ion, prints,
drawi ngsandmanual s.
•Document edSof twar e.
•Env i
ronment al condi t i
onsoft he
manuf act ur ingar ea( suchascl ean
room r equi rement s,
temper at ur e, andhumi di ty).
[Link] at ionalQual ificat i
on( OQ) :Thepr ocessorequi pmentar eoper at i
ngcor [Link] ational
qualificat i
on( OQ)shoul df ollowI nst allationqual if
icat i
on.
OQconsi der at i
onsi ncl ude:
•Cont rol l
imi tsofPr ocess( time,
temper at ur e, pr essur e, li
nespeed, set upcondi ti
ons, etc.)
•Softwar epar amet ers.
•Speci ficat i
onsofr awmat er i
al . •Oper atingpr ocedur esf ort hepr ocess.
•Mat er ial handl ingr equi rement s.
•Processchangecont rol .
•Training.
[Link] for manceQual ificat ion( PQ)
Thepr ocessorequi pmentper formsasi nt endedi naconsi stentmannerov ert ime.I t
shoul df ollowsuccessf ul compl etionof Installationqual i
f i
cat ionandOper ati
onal qualif
icat i
on.
PQconsi der ationsi ncl ude:
•Actual pr oductandpr ocesspar amet er sandpr ocedur esest abl i
shedi nOQ.
•Accept abi l
ityoft hepr oduct .
•Assur anceofpr ocesscapabi lityas
establ ishedi nOQ.
•Processr epeat abi lity,longt er m pr ocessst abi l
i
ty.
[Link]–Qual ificat ion: Thi sf or malr ev i
ew shoul di ncl udeconsi derationofr e-qual ifi
cat i
onoft he
equipment .Mi norchangesorchangeshav i
ngnodi rectef fect i
ngf inalori n- processpr oduct
qualityshoul dbehandl edt hr ought hedocument at i
onsy st em oft hepr ev ent iv
emai ntenance
progr am.
Appr oacht oPr ocessVal i
dat ion
Processv alidat iondef inedast hecol l
ect i
onandev aluat ionofdat a,f rom t hepr ocessdesi gn
staget hr oughcommer cialpr oduct i
on, whichi ncludesci ent i
f i
cev idencet hatapr ocessi scapabl e
ofconsi st ent l
ydel iver ingqual it
ypr oduct .Pr ocessThi sgui dancedescr i
bespr ocessv ali
dat ion
activitiesi nt hr eest ages.
Stage1–Pr ocessDesi gn: Thecommer cialmanuf act uringpr ocessi sdef i
neddur i
ngt hisst age
basedonknowl edgegai nedt hr oughdev elopmentandscal e- upact ivities.
Stage- -
2–Pr ocessQual i
f i
cat ion:
Dur i
ngt hi sst age,t hepr ocessdesi gni sev aluat edt odet er mi nei ft hepr ocessi scapabl eof
reproduci blecommer ci al manuf act uring.
Stage3–Cont inuedPr ocess:
Verificat ion:Ongoi ngassur ancei sgai neddur ingr out i
nepr oduct i
ont hatt hepr ocessr emai nsi na
stateofcont rol .Bef or eanybat chf rom t hepr ocessi scommer cial l
ydi st ri
but edf oruseby
consumer s, amanuf act urershoul dhav egai nedahi ghdegr eeofassur ancei nt heper for manceof
themanuf act ur ingpr ocesssucht hati twi l
lconsi stent lypr oduceAPI sanddr ugpr oduct smeet ing
thoseat tribut esr el atingt oi dent ity,st rengt h,qual ity,pur ity ,andpot ency .Theassur anceshoul d
beobt ai nedf rom obj ect ivei nf ormat ionanddat af r
om l abor ator y-pilot -,and/ orcommer cial-scale
studies.I nf or mat i
onanddat ashoul ddemonst ratet hatt hecommer ci al. manuf acturingpr ocess
i
s capabl e of consi st ently pr oduci ng accept abl e qual i
ty pr oduct s wi thi
n commer cial
manuf act ur ingcondi tions.
Asuccessf ulv al i
dat i
onpr ogr am dependsuponi nf ormat ionandknowl edgef rom pr oductand
process dev elopment .Thi s knowl edge and under standi ng i st he basi sf orest ablishing an
approacht ocont roloft hemanuf act uringpr ocesst hatr esul ti npr oduct swi tht hedesi redqual ity
attr
ibut es.
Manuf act ur er sshoul d:
Under st andt hesour cesofv ar i
at ion
Detectt hepr esenceanddegr eeofv ar i
at i
on
Under st andt hei mpactofv ariat i
onont hepr ocessandul ti
mat elyonpr oductat tributes
Cont rol thev ar iat i
oni namannercommensur atewi tht her i
ski trepr esent stot hepr ocess.
Stage1―Pr ocessDesi gn
Processdesi gni st heact ivi
tyof
def i
ni ng t he commer cialmanuf actur i
ng pr ocess t hatwi llbe r ef lected in pl anned mast er
product ionandcont rol records.
Thegoal ofthisst agei st odesi gna
processsui tablef orr out inecommer cial
manuf actur i
ngt hatcanconsi stently
deliverapr oductt hatmeet sitsqual i
tyat tributes.
[Link] ldingandCapt ur ingPr ocess
Knowl edgeandUnder standi ngGener ally,ear lypr ocessdesi gnexper i
ment sdonotneedt obe
per formedundert heCGMPcondi t
ionsr equi redf ordr ugsi ntendedf orcommer cialdi st
ri
but i
on
thatar emanuf act ureddur ingSt age2( processqual ificat i
on)andSt age3( cont inuedpr ocess
verificat i
on) .Theyshoul d,howev er,beconduct edi naccor dancewi thsoundsci entifi
cmet hods
andpr i
nciples,i ncl udi nggooddocument at i
on. pr act i
[Link] sionsandj ust ifi
cationoft he
cont rol sshoul dbesuf fi
cientlydocument edandi nter nal lyr eviewedt ov eri
fyandpr eservet heir
valuef oruseoradapt at ionl ateri
nt hel ifecy cleoft hepr ocessandpr oduct .
Pr oductdev elopmentact ivi
ti
espr ovidekeyi nputst ot hepr ocessdesi gnst age,suchast he
i
nt endeddosagef or m,t hequal it
yat tr
ibut es,andagener almanuf acturingpat hway .Pr ocess
i
nf ormat ionav ai l
abl ef rom pr oductdev elopmentact ivitiescanbel ever agedi nt hepr ocessdesi gn
[Link] unct i
onal ityand l i
mi t
ations ofcommer cialmanuf acturing equi pmentshoul d be
consi der edi nt hepr ocessdesi gn,aswel laspr edi ct edcont r i
butionst ov ar iabilit
yposedby
differentcomponentl ots,production oper ators,env ironment alcondi ti
ons,and measur ement
syst emsi nt hepr oduct i
onset t
[Link] er,t hef ullspect r
um ofi nputv ar i
abi li
tyt ypi
calof
commer cialpr oduct ioni snotgener allyknownatt hi sst [Link] at oryorpi lot -
scal emodel s
desi gnedt ober epr esent ativeoft hecommer cialpr ocesscanbeusedt oest i
mat ev ari
abi l
i
ty.
Desi gni nganef ficientpr ocesswi thanef fect i
vepr ocesscont r
olappr oachi sdependentont he
processknowl edgeandunder st
andi ngobt [Link] gnofExper i
ment( DOE)st udiescanhel p
dev elop pr ocess knowl edge by r ev ealing r elationshi ps,i ncluding mul ti
var i
at ei nteractions,
bet weent hev ar i
abl ei nput s(e.g.,componentchar act eristics13orpr ocesspar amet ers)andt he
resul tingout put s( e.g. ,in-processmat erial,intermedi at es, ort hef i
nal pr oduct).

[Link] ishi ngaSt rat egyf orPr ocessCont rolProcessknowl edgeandunder standingi sthebasi s
forest abl ishinganappr oacht opr ocesscont rolf oreachuni toper ati
onandt hepr ocessov erall.
Strategiesf orpr ocesscont rolcanbedesi gnedt or educei nputv ari
at i
on, adjustf orinputv ariati
on
duringmanuf actur i
ng( andsor educei t
si mpactont heout put),orcombi nebot happr [Link]
expect scont rolst oi ncludebot hexami nat i
onofmat erialqualit
yandequi pmentmoni tor i
ng.
Speci alat t
ent iont ocont rolt hepr ocesst hr oughoper ationallimitsandi n-processmoni toringi s
essent ial int wo
possi blescenar ios:
[Link] t he pr oductat tri
but ei s notr eadi ly measur abl e due tolimitations ofsampl ing or
detect abi l
ity( e.g.,viral clearanceormi crobi alcont ami nation)
[Link] ntermedi atesandpr oduct scannotbehi ghlychar acteri
zedandwel l-
def i
nedqual it
y
attri
but escannotbei dent if
ied.
Thepl annedcommer cialpr oduct ionandcont r
olr ecords,whi chcont aint heoper ational
l
imi tsandov erallst rategyf orpr ocesscont rol,shoul dbecar r
iedf orwar dt ot henextst agef or
conf i
rmat ion.
Stage2―Pr ocessQual if
icat i
on
Dur i
ngt hepr ocessqual if
icat i
on( PQ)st ageofpr ocessv alidat
ion,thepr ocessdesi gni sev aluat ed
to det ermi nei fiti scapabl eofr epr oduci blecommer cialmanuf [Link] sst agehast wo
element s:desi gnoft hef acil
ityandqual ifi
cati
onoft heequipmentandut i
liti
esandpr ocess
perfor mancequal i
ficat i
on( PPQ) .Dur ingSt age2, CGMP- compl i
antpr ocedur esmustbef ollowed.
Successf ul compl etionof
Stage2i snecessar ybef orecommer cialdi stri
bution. 15Pr oductsmanuf act ureddur ingt hi
sst age,
i
faccept abl e,canber eleasedf ordi st r
ibut i
on.
[Link] gn ofa Faci li
ty and Qual ification ofUt il
iti
es and Equi pmentPr operdesi gn ofa
manuf act ur i
ngf acil
ityi sr equiredunderpar t211, subpar tC, oftheCGMPr egulationson
BuildingsandFaci l
ities.I tisessent ialt hatact iv
itiesper f
ormedt oassur epr operf acili
tydesi gn
andcommi ssi oni ngpr [Link] e,t het erm qual ifi
cat ionr efer st oact i
v i
tiesunder t akent o
demonst r atet hatut i
litiesandequi pmentar esui tabl ef ort hei ri nt endeduseandper for m pr oper ly
.
Theseact ivitiesnecessar il
ypr ecedemanuf act uringpr oduct satt hecommer cial scal e.
Qual ificat ionofut i
litiesandequi pmentgener al l
yi ncludest hef ol l
owi ngact iv i
ties:
Select ingut ili
tiesandequi pmentconst ruct ionmat er ials,oper at ingpr inci ples,andper for mance
char act er ist icsbasedonwhet hert heyar eappr opr i
at ef ort hei rspeci ficuses.
Ver i
fy ingt hatut il
itysy st emsandequi pmentar ebui ltandi nst al ledi ncompl iancewi tht hedesi gn
speci ficat ions( e. g., bui ltasdesi gnedwi thpr opermat erials, capaci ty,andf unct ions,
andpr oper lyconnect edandcal i
br at ed) .
Ver i
fy ing t hat ut ility sy st ems and equi pment oper at ei n accor dance wi t ht he pr ocess
requi rement si nal lant icipat edoper atingr [Link] sshoul di ncl udechal lengi ngt heequi pment
orsy st em f unct ionswhi l
eunderl oadcompar abl et ot hatexpect eddur ingr out inepr oduct ion.I t
shoul dal soi ncl udet heper f ormanceofi nt ervent ions,st oppage,andst ar t-upasi sexpect ed
duringr out inepr oduct ion.
Oper at ingr angesshoul dbeshowncapabl eofbei nghel dasl ongaswoul dbenecessar ydur ing
routinepr oduct ionQual ificat ionofut il
iti
esandequi pmentcanbecov er edunderi ndi vi
dualpl ans
oraspar tofanov eral lpr ojectpl [Link] anshoul dconsi dert her equi rement sofuseandcan
i
ncor por at er iskmanagementt opr ior it
izecer tainact ivitiesandt oi dent ifyal ev elofef f
or tinbot h
theper for manceanddocument ationofqual ificationact i
v i
ties.
Thepl anshoul dident i
f yt hef ollowi ngi tems:
 Thest udi esort est st ouse,
 Thecr iteriaappr opr iatet oassess
out comes,
 Thet i
mi ngofqual i
ficat i
onact ivities,
 Ther esponsi bi li
t iesofr elev ant
depar t
ment sandt hequal ityuni t
, and
 Thepr ocedur esf ordocument ingandappr ov i
ngt hequal ifi
cat ion.
[Link] ocessPer for manceQual ificat ion:Thepr ocessper formancequal ificat i
on
(PPQ)i st hesecondel ementofSt age2,pr ocessqual if
icat [Link] combi nest heact ual
facili
ty ,ut il
ities,equi pment( eachnowqual ified) ,andt het rai nedper sonnelwi tht hecommer cial
manuf act ur ingpr ocess, cont rol pr ocedur es, andcomponent st opr oducecommer cial batches.
A successf ulPPQ wi llconf ir
m t he pr ocess desi gn and demonst rat et hatt he commer cial
manuf act ur ingpr ocessper for msasexpect ed.
Successatt hi sst agesi gnal san
i
mpor tantmi lest onei nt hepr oduct
l
ifecy cl [Link] act ur ermust
successf ullycompl etePPQbef or e
commenci ngcommer ci aldi st ribut ionoft hedr ugpr oduct .Thedeci siont obegi ncommer cial
distribut i
onshoul dbesuppor tedbydat af romcommer cial-scal ebat [Link] af rom l abor ator y
andpi lotst udi escanpr ov ideaddi tional assur ancet hatt hecommer cial
manuf act ur ingpr ocessper for msas
expect ed. Theappr oacht oPPQshoul dbebasedonsoundsci enceandt hemanuf act urer’
sov er al
l
l
ev el ofpr oductandpr ocessunder st andi nganddemonst rabl e
cont rol .Thecumul at i
v edat af rom al l r
el ev antst udies( e.g., desi gned
exper iment s; labor ator y , pilot ,and
commer cialbat ches)shoul dbeusedt oest abl i
sht hemanuf act ur ingcondi tionsi nt [Link]
under st andt hecommer cial pr ocesssuf fi
ci ent ly,themanuf act ur erwi llneedt oconsi dert he
effect sofscal [Link] er ,itisnot
typical lynecessar yt oexpl oret heent ire
oper at ingr angeatcommer cialscal ei fassur ancecanal sobehel pf ul .Inaddi t i
on, west r
ongl y
recommendf i
rmsempl oyobj ect ivemeasur es( e.g.,st at i
st icalmet r i
cs)wher ev erf easibl eand
meani ngf ul toachi ev eadequat eassur ance.
[Link] ot ocolAwr ittenpr ot ocolt hatspeci fi
est hemanuf act ur ingcondi ti
ons,cont rols,t est ing,
andexpect edout comesi sessent ialf ort hi sst ageofpr ocessv al idat [Link] ecommendt hatt he
protocol di scusst hef ol lowi ngel ement s:
  Themanuf act ur ingcondi tions,
incl udi ngoper at i
ngpar amet ers,
pr ocessi ngl imi ts, andcomponent
(rawmat er ial)input s.
 Thedat at obecol lect edandwhenandhowi twi llbeev al uat ed.
 Test st obeper for med( in-pr ocess,
r elease, char act er izat ion)and
accept ancecr i
ter iaf oreachsi gni ficant
pr ocessi ngst ep.
 Thesampl ingpl an,i ncl udi ngsampl ingpoi nt s,numberof sampl es,andt hef r
equencyof
sampl ing f oreach uni toper at ion and at tribut [Link] esshoul d be
adequat et opr ov idesuf fici entst at ist i
calconf idenceofqual i
tybot hwi thi nabat chand
bet weenbat [Link] idencel ev elsel ect edcanbebasedonr iskanal y sisasi t
rel atest ot hepar ti
cul arat tr i
but eunderexami nat [Link] i
ngdur i
ngt hisst ageshoul d
bemor eext ensi v et hani st ypi cal dur ingr out inepr oduct ion.
 Cr iteriaandpr ocessper for mance
indi cator st hatal lowf orsci ence- and
risk- baseddeci si onaboutt heabi lityof
pr ocesst oconsi stent lypr oducequal ity
pr oduct s.
Thecr i
teriashoul di ncl ude:
 A descr i
pt ion of t he st at istical met hods t o be used i n anal yzing al l
col lect ed dat a( e.g. ,st atist icalmet ri
cs def i
ning bot hi nt r
a- bat ch and i nter -
batch
v ariabi l
ity).
 Pr ov i
sion f oraddr essi ng dev iat ions f rom expect ed condi ti
ons and handl ing ofnon
conf or mi ngdat [Link] ashoul dnotbeexcl udedf rom f urtherconsi der at i
oni nt er msof
PPQwi thoutadocument ed, sci ence- basedj ust if
icat i
on..
 Desi gnoff aci liti
esandt hequal ificat ionofut ili
tiesandequi pment , personnelt rainingand
qual ifi
cat ion,andv erificat ionofmat erialsour ces( component sandcont ainer/cl osures),
ifnotpr ev iousl yaccompl ished.
 St at usoft hev al idat ionofanal y ticalmet hodsusedi nmeasur ingt hepr ocess,i n- process
mat eri
al s,and t he pr oduct .Rev iew and appr ov aloft he pr otocolby appr opri
at e
depar t
ment sandt hequal ityuni [Link] age3―Cont i
nuedPr ocessVer i
fication.
Thegoaloft het hir dv al i
dat ionst agei scont inualassur ancet hatt hepr ocessr emai nsina
stateofcont rol( thev alidat edst at e)dur i
ngcommer cialmanuf act [Link] stem orsy st emsf or
detect ingunpl anneddepar tur esf rom t hepr ocessasdesi gnedi sessent i
alt oaccompl isht his
goal .Adher encet ot heCGMPr equi rement s, speci fi
cal ly ,t
hecol lect ionandev aluat ionof
i
nf ormat ionanddat aaboutt heper for manceoft hepr ocess,wi llal l
ow det ect ionofundesi red
process v ar i
abi l
[Link] aluat ing t he per f ormance of t he pr ocess i dent ifi
es pr oblems and
deter mi neswhet heract ionmustbet akent ocor rect ,ant icipat e, andpr ev entpr obl emssot hatthe
processr emai nsi ncont rol .
Anongoi ngpr ogr am t ocol l
ectandanal y sepr oductandpr ocessdat at hatr el atet opr oduct
qual i
tymustbeest abl [Link] acol lect edshoul di ncl uder elev antpr ocesst r endsand
qual i
tyofi ncomi ngmat er ial sorcomponent s, in-processmat er i
al ,andf i
ni shedpr oduct [Link]
dat ashoul dbest atist i
cal l
yt rendedandr ev iewedbyt rainedper sonnel .
The i nfor mat i
on col lect ed shoul dv er i
f yt hatt he qual ityat tribut es ar e bei ng appr opr i
ately
cont rolledt hroughoutt hepr ocess.
Wer ecommendt hatast atist icianorper sonwi thadequat et rainingi nst at i
st i
calpr ocesscont rol
techni quesdev elopt hedat acol lect ionpl anandst at i
st ical met hodsandpr ocedur es
usedi nmeasur ingandev al uat ingpr ocessst abi l
ityandpr ocesscapabi lity
.Pr ocedur esshoul d
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