product quality review

8/21/2019 Product Quality Review

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Product Quality Review[Product Name Dosage Strength Dosage Form]

N PQR_XXX_YYYY

Period: DD/MM/YYYY - DD/MM/YYYY

Disiapkan Oleh :

Prepared By Tanggal

Date

Disetujui Oleh :

Approved By Tanggal

Date

Disetujui Oleh :

Approved By Tanggal

Date

Disetujui Oleh :

Approved By Tanggal

Date

Disetujui Oleh :

Approved By Tanggal

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Disetujui Oleh :

Approved By

Tanggal

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1. Corrections

Onl! appli"a#le $or su#se%uent &ersion in "ase an error is noti"ed or additionalin$or'ation #e"o'es a&aila#le a$ter appro&al and distri#ution(

2. General Information

Pro&ide a short s!nopsis o$ the report "ontain the produ"t des"ription) the 'anu$a"turingsite) and the re&ie* period(

Rationale *h! the re&ie* period has #een shortened or e+tended(

3. Executive summary

,u''arie the out"o'e o$ the re&ie* in"luding "orre"ti&e a"tions $ro' pre&ious reportsthat *ere i'ple'ented in this re&ie* period) an! signi$i"ant issues or "hanges reportedin this reporting period. There should #e a "lear state'ent on the "urrent status o$ theprodu"t regarding the status o$ "ontrol) pro"ess "apa#ilit! and state o$ "o'plian"e(

4. atc!es manufactured

ist o$ all #at"hes 'anu$a"tured) released) pending release) and nu'#ers in"luding$ailed #at"hes/reje"tions during the re&ie* period $or spe"i$i" produ"t. 0aps in #at"hnu'#ering) e.g. due to &alidation lots pending appro&al or orders are "an"elled #e$ore

an! produ"tion "o''en"ed) 'ust #e e+plained in detail 1Ta#le 2-D(

"a#le 3$1 atc!es %anufactured

%aterial&ame

%aterial&o.

atc!es%anufactured

atc!esReleased

atc!es Pendin'Release

atc!esRe(ected

ist all #at"hes that *ere re*orked or repro"essed during the re&ie* period) in"luding ades"ription o$ the steps taken to re*ork or repro"essing and the pro"edure nu'#er used1Ta#le 2-34(

"a#le 3$2 Rewor) or Re*rocessin'

%aterial&ame %aterial&o. atc!&o.

+escri*tion of t!e

Rewor), Re*rocess-*eration

ProcedureReference %aterialtatus +eviationReference

Des"ri#e the produ"tion pro"ess $lo* diagra'(




/. tartin' %aterials and 0endor Performance

This se"tion is a su''ar! on %ualit! o$ starting 'aterials and supplier %ualit!per$or'an"e(

/.1 &ew ources

ist and report all ra* 'aterials 15P6s) e+"ipient and pa"kaging 'aterials4 i$ pur"hased $ro' ne* sour"e $or the 'anu$a"turing o$ the produ"t "on"erned and listthe status o$ the 'anu$a"turer 1Ta#le 7-84(

"a#le 4$1 tartin' %aterial &ew ources -ri'inal manufacturer

%aterial &ame %aterial &o. %anufacturer &ame %anufacturer tatus udit tatus

/.2 0endor Performance

ist the 'aterial na'e) 'aterial nu'#er) 'anu$a"turer 6d) 'anu$a"turer status as*ell as nu'#er o$ #at"hes re"ei&ed) released) pending release and reje"ted duringthe re&ie* period and list all de&iation related to supplier to assess the per$or'an"eo$ &endor 1Ta#le 7-34(

"a#le 4$2 Raw %aterial Received

%ateria

l &ame

%ateria

l &o.

%anufacture

r &ame

%anufacture

r

tatus

udit

tatu

s

&um#er

of

#atc!es

Receive

d

&um#er

-f

at!es

Released

&um#er

of

Pendin'

Release

&um#er

of at!es

Re(ected

. nalytical +ata and "rend nalysis

ist the Testing Monographs that ha&e #een applied 1Ta#le 9-84 and short "on"lusiona#out data %ualit! and trends(

"a#le /$1 "estin' %ono'ra*!s

%aterial &ame %aterial &o. +ocument Code Im*lementation +ate

.1 nalytical +ata for Quality Parameters

Pro&ide a &isual trending o$ the data using "ontrol "hart and an o&erall state'ent asto the degree o$ pro"ess "ontrol o#ser&ed during the re&ie* period(




/.1.1 IPC$data

Des"ri#e all "riti"al in-pro"ess "ontrols and $inished produ"t results. +plain de&iations and"orre"ti&e a"tion i$ appli"a#le(

"a#le /$2 IPC Results

ta'e of t!e*rocess

Critical Parameter cce*tance Criteria ctual Results Remar)

/.1.2 %icro#iolo'ical +ata

;o''ent on the o&erall per$or'an"e o$ the 'i"ro#iologi"al data(

/.1.3 nalytical %et!od "rends 5or Release atc!es

ist the test results and trends $ro' Q; tests $or "o''er"ial release #at"hes(.

"a#le /$3 nalytical Results

Critical Parameter cce*tance Criteria ctual Results Remar)

/.1.4 Ca*a#ility Process Evaluation

,tatisti"al anal!sis should #e used to assess pro"ess sta#ilit! and "apa#ilit!) in"ludingpro&ide "ontrol "hart into the se"tion.(

"a#le /$4 tatistical nalysis #ased on Control C!art IPC Results

&o. "est Parameter *ecification 6imit66786

Control 6imit6C6 7 8C6

Result ofControl C!art

Remar)

"a#le /$/ Process Ca*a#ility nalysis IPC Results

&o. "estParameter

*ecification6imit 66 7 86


C*value

C*)value

PP%total

i'mavalue

Remar)

"a#le /$ tatistical nalysis #ased on Control C!art nalytical Results

&o. "est Parameter *ecification 6imit66 7 86



Remar)




"a#le /$9 Process Ca*a#ility nalysis nalytical Results

&o."estParameter

*ecification 6imit66 7 86


C*value

C*)value

PP%total

i'mavalue

Remar)

.2 Results of t!e Product ta#ility %onitorin' Pro'ram

ist all #at"hes enrolled in the produ"t sta#ilit! progra' 1Ta#le 9-<4. ,u''arie sta#ilit!data o$ all #at"hes on sta#ilit!. ,tatisti"al anal!sis 'ust #e used to e&aluate theade%ua"! o$ "urrent internal release li'its(

"a#le /$: ta#ilities tudies

%aterial &ame %aterial &o. atc! &o. tudy "y*e "ime Point Condition

"a#le /$; tatistical nalysis #ased on Control C!art ta#ility Results

&o.ta#ilityPro'ram

"estParameter

*ecification6imit 66 7 86



Remar)

"a#le /$1< Process Ca*a#ility nalysis ta#ility Results

&o.ta#ilityPro'ram

"estParameter

*ecification 6imit 66786

Control 6imit6C678C6

C*value

C*)value

PP%total

i'mavalue

Remar)

.3 -ut of *ecifications

ist the nu'#er o$ "on$ir'ed and un-"on$ir'ed OO,) in"luding the root "ause) "orre"ti&eand pre&enti&e a"tions 1Ta#le 9-884(

"a#le /$11 -- -verview "a#le

%aterial&ame

%aterial&o.

&um#er of --

Confirmed,8ncorfimed

Reference to+eviation &o.

RootCause

CP




"a#le /$12 -- tatus

&o. !ort +escri*tion tatus

9. +eviations

ist all "riti"al and not "riti"al de&iations 1Ta#le =-84(

"a#le $1 +eviation -verview "a#le

&o.

%aterial

&ame %aterial &o.

atc!

&o.

6ocal

atc! &o.

&um#er of

+eviations

Critically

Critical,&on$critical

+efect

"y*e

>or all "riti"al and non-"riti"al de&iations) pro&ide a short des"ription) root "ause and ;5P51Ta#le =-34(

"a#le $2 Critical +eviations

&o. !ort +escri*tion Root Cause CPtatus of +eviationRe*ort

"a#le $3 &on$Critical +eviations

&o. !ort +escri*tion Root Cause CPtatus of +eviationRe*ort

:. C!an'es to Process and nalytical %et!ods and *ecifications

:.1 Process C!an'es

Pro&ide the su''ar! in ta#le $or'at 1Ta#le ?-84 or state that no pro"ess "hanges ha&e#een per$or'ed in"luding 'aterial and 'anu$a"turing e%uip'ent(

"a#le 9$1 ummary of Process C!an'es

C!an'e &o. C!an'e "y*e !ort +escri*tion +ate of **roval tatus Remar)




:.2 nalytical C!an'es

Pro&ide the su''ar! in ta#le $or'at 1Ta#le ?-34 or state that no anal!ti"al "hanges ha&e#een per$or'ed(

"a#le 9$2 ummary of nalytical C!an'es


:.3 *ecification C!an'es

Pro&ide the su''ar! in ta#le $or'at 1Ta#le ?-24 or state that no spe"i$i"ation "hanges ha&e#een per$or'ed(

"a#le 9$3 ummary of *ecifications C!an'es


:.4 -t!er C!an'es

Pro&ide the su''ar! in ta#le $or'at 1Ta#le ?-74 or state that no other "hanges ha&e #eenper$or'ed(

"a#le 9$4 ummary of -t!er C!an'es


;. 0alidation Review

5ll &alidation a"ti&ities per$or'ed during the re&ie* period 'ust #e listed 1Ta#le 8@-84)in"luding the reason) #at"h and re$eren"e to the &alidation report) it in"ludes details o$ an!pro"ess &alidation a"ti&ities per$or'ed during the re&ie* period 1'anu$a"turing pro"esses)"leaning pro"edures) la#orator! 'ethods) reason $or re&alidation and results o$ &alidation4(




"a#le :$1 ummary of 0alidation ctivities

Process te* 0alidation +ocument Reference tatus

1<. Qualification tatus of Relevant E=ui*ment and 8tilities

Quali$i"ation status o$ rele&ant 1'ajor4 e%uip'ent and utilities 'ust #e listed *ith "hangesand de&iations to the %uali$i"ation status su''aried 1Ta#le A-84. The #asis $or the re&ie*should #e the "urrent &alidation 'aster plan(

"a#le ;$1 ummary of Qualified E=ui*ment and 8tilities

E=ui*ment, 8tilityI+E=ui*ment

Qualificationtatus

C!an'e,+eviation

&extQualification

11. Review of Quality tec!nical a'reements

Qualit! 5gree'ents *ith "ontra"tors or suppliers should #e re&ie*ed $or up-to-dateness

1'anu$a"turer "ontra"tor) test la#) supplier RM/PM4) in"ludes internal ,ando 5gree'ent1Ta#le 8@-84(

"a#le 1<$1 Quality 'reement

&ame of Contractor,ando> ffiliates

Reference +ate of review 0alid ?es, &o Remar)

12. Com*liance wit! )ey re'ulation attri#utes

Pro&ide a state'ent on the status o$ "o'plian"e $or the &eri$i"ations o$ the ke! regulator!attri#utes at a 'ini'u'. 5ppropiate a"tions are to #e "reated $or an! identi$ied "o'plian"egaps. The DR5 is responsi#le to pro&ide input on post 'arketing "o''it'ents.

+a'ples:

The re&ie* o$ the site do"u'entation against registratioon dossiers *as per$or'ed and$ound to #e "o'pliant an satis$a"tor!.

Or




The re&ie* o$ the site do"u'entation against registration dossiers *as per$or'ed and thegaps identi$ied are #eing re'ediated &ia "hange "ontrol s!ste'(

"a#le 11$1 @ey Re'ulatory ttri#utes

%anufacturin' ite&ame

6ocationPac)a'in'ite

6ocation!elf 6ife

+escri*tion of%anufacturin'Process

nalytical"est ite

6ocation+escri*tionof ProcessControls

5ll in$or'ation regarding su#'itted) granted or re$used 'arketing authoriations and post-'arketing "o''it'ents $or ne* 'arketing authoriations and &ariations to 'arketingauthoriations should #e listed. The DR5 is responsi#le to pro&ide input regarding su#'itted)granted or re$used 'arketing authoriations and &ariations there o$(

12. Com*laints

12.1 "ec!nical Com*laints

ist all te"hni"al "o'plaints during the re&ie* period. ;on"lusion 'ade as a result o$ thein&estigation should #e in"luded 1Ta#le 83-84. Medi"al "o'plaints *hi"h results in te"hni"al"o'plaint e&aluation are in"luded in the o&erall list and su''ar!(

"a#le 12$1 ummary of "ec!nical Com*laints

Com*laint&o.

%aterial&ame

%aterial&o.

atc!&o.

!ort+escri*tion

RootCause

CP Conclusion

12.2 %edical Com*laints dverse Event

Pro&ide a state'ent on 'edi"al "o'plaints and the "orresponding e&aluation(

13. ReturnA RecallsA %ar)et Bit!drawalsA Re'ulatory lert

13.1 Returned Products

ist an! returned drug produ"ts. The list should in"lude the #at"h nu'#er and reason $or returning) in&estigation and $inal de"ision and also "orre"ti&e and pre&enti&e a"tion *hi"hhad #een done 1Ta#le 82-84(

"a#le 13$1 ummary of Returned Product

atc! &o. "otal &um#er of Returned Reason




13.2 Recalls or %ar)et Bit!drawals

ist an! #at"hes *ithdra*als or re"alls) along *ith the reason $or re"all or *ithdra*al 1Ta#le

82-34(

"a#le 13$2 ummary of Recalls

atc! &o. "otal &um#er of Recalls Reason

14. ction "a)en 5ollowin' Previous PQR

,u''ar! and status o$ a"tions taken 1in"luding re&alidation a"ti&ities4 $ollo*ing the

"on"lusions and re"o''endations $ro' pre&ious PQR. 5n! ongoing ;o'plian"e or

re'ediation a"ti&ities are re&ie*ed) and an! o&erdue a"tions identi$ied(

1/. nnual 0isual Examination of Retain am*les of 5inis!ed Products 5or 8 PR

only

Per$or' a &isual e+a'ination on retain sa'ple and re&ie* the result on "on$or'an"e to the

spesi$i"ations. +a'ination per$or' onl! $or e+ported produ"t to B,5 or #e"ause other spe"i$i" reason 1"urrentl! not re%uired4(

1. Conclusions and Recommendations

1.1 de=uancy of Previous Recommendations

Pro&ide a state'ent on the su""es o$ "orre"ti&e a"tion in the last reporting period(

1.2 Conclusions and &ew Recommendations

&aluate all datas as a *hole. ,u''arie and re"o''endate these data $or a"tions)

in"luding re&alidation a"ti&ities i$ needed(

"a#le 1$1 CP PIan

ction +escri*tions PIC +ue +ate

19. nnexes

1:. +istri#ution

product quality review

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