In the current scenario, the data on the web is growing exponentially. Social media is generating a large amount of data such as reviews, comments, and customer's opinions on a daily basis. This huge amount of user generated data is worthless unless
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View the 2017-2018 New BQL Catalog Online! To request a print copy, distributors and vendors interested in becoming a distributors should email Marketing at: [email protected] Copyr...Full description
Annual product quality reviewFull description
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In real time problem is the finding the top k profitable product in the existing market. To find in the best product in the market such the new product could not dominate by other product in the market. Authentication and skyline analysis are best de
This paper develops and tests a theoretical model of the effects of nutritional label and brand name on consumers product quality perceptions in Pakistani consumer market. The basic aim of the study is to investigate the extent to which consumers for
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The Pharmaceutical Quality By Design QBD is a systematic approach to the development that starts with the predetermined objectives and is based on the process of understanding process processes and process control, sound science and quality risk mana
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The Pharmaceutical Quality By Design QBD is a systematic approach to the development that starts with the predetermined objectives and is based on the process of understanding process processes and process control, sound science and quality risk mana
Now a days online shopping will become increasingly important. Merchant sells the product more and more on the internet and many users are using the internet to buy a product and express their ideas or opinions about that product. Many users are usin
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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
Disetujui Oleh : Approved By
Disetujui Oleh : Approved By
Disetujui Oleh : Approved By
Disetujui Oleh : Approved By
Tanggal Date
Tanggal Date
Tanggal Date
Tanggal Date
Tanggal Date
Disetujui Oleh : Approved By Tanggal Date
Product Quality Review [Product Name Dosage Strength Dosage Form] 1. Corrections Onl! appli"a#le $or su#se%uent &ersion in "ase an error is noti"ed or additional in$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$a"turing site) and the re&ie* period( Rationale *h! the re&ie* period has #een shortened or e+tended( 3. Executive summary ,u''arie the out"o'e o$ the re&ie* in"luding "orre"ti&e a"tions $ro' pre&ious reports that *ere i'ple'ented in this re&ie* period) an! signi$i"ant issues or "hanges reported in this reporting period. There should #e a "lear state'ent on the "urrent status o$ the produ"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"h nu'#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$1 %aterial &ame
ist all #at"hes that *ere re*orked or repro"essed during the re&ie* period) in"luding a des"ription o$ the steps taken to re*ork or repro"essing and the pro"edure nu'#er used 1Ta#le 2-34( "a#le 3$2
Rewor) or Re*rocessin' +escri*tion of t!e %aterial %aterial atc! Procedure Rewor), Re*rocess &ame &o. &o. Reference -*eration
Des"ri#e the produ"tion pro"ess $lo* diagra'(
%aterial +eviation tatus Reference
Product Quality Review [Product Name Dosage Strength Dosage Form] /. tartin' %aterials and 0endor Performance This se"tion is a su''ar! on %ualit! o$ 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 list the status o$ the 'anu$a"turer 1Ta#le 7-84( "a#le 4$1 %aterial &ame
/.2 0endor Performance ist the 'aterial na'e) 'aterial nu'#er) 'anu$a"turer 6d) 'anu$a"turer status as *ell as nu'#er o$ #at"hes re"ei&ed) released) pending release and reje"ted during the re&ie* period and list all de&iation related to supplier to assess the per$or'an"e o$ &endor 1Ta#le 7-34( "a#le 4$2
%ateria l &ame
%ateria l &o.
Raw %aterial Received
%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"lusion a#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 as to the degree o$ pro"ess "ontrol o#ser&ed during the re&ie* period(
Product Quality Review [Product Name Dosage Strength Dosage Form] /.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 /$2 IPC Results ta'e of t!e Critical Parameter cce*tance Criteria ctual Results *rocess
Remar)
/.1.2 %icro#iolo'ical +ata ;o''ent on the o&erall per$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; t ests $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"luding pro&ide "ontrol "hart into the se"tion.( "a#le /$4
tatistical nalysis #ased on Control C!art IPC Results
&o. "est Parameter
*ecification 6imit Control 6imit 66786 6C6 7 8C6
Result of Control C!art
"a#le /$/ Process Ca*a#ility nalysis IPC Results &o. "est *ecification Control 6imit C* C*) PP% Parameter 6imit 66 7 86 6C6 7 8C6 value value total
"a#le /$
Remar)
i'ma value
Remar)
tatistical nalysis #ased on Control C!art nalytical Results
&o. "est Parameter
*ecification 6imit Control 6imit 66 7 86 6C6 7 8C6
Result of Control C!art
Remar)
Product Quality Review [Product Name Dosage Strength Dosage Form]
.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 the ade%ua"! o$ "urrent internal release li'its( "a#le /$:
ta#ilities tudies
%aterial &ame
"a#le /$; &o.
ta#ility Pro'ram
"a#le /$1< &o.
%aterial &o. atc! &o.
tudy "y*e "ime Point
Condition
tatistical nalysis #ased on Control C!art ta#ility Results "est Parameter
*ecification Control 6imit Result of Remar) 6imit 66 7 86 6C6 7 8C6 Control C!art
Process Ca*a#ility nalysis ta#ility Results
ta#ility "est *ecification 6imit Control 6imit C* C*) PP% i'ma Remar) Pro'ram Parameter 66786 6C678C6 value value total value
.3 -ut of *ecifications ist the nu'#er o$ "on$ir'ed and un-"on$ir'ed OO,) in"luding the root "ause) "orre"ti&e and pre&enti&e a"tions 1Ta#le 9-884( "a#le /$11
-- -verview "a#le
%aterial %aterial &um#er of Confirmed, &ame &o. -- 8ncorfimed
>or all "riti"al and non-"riti"al de&iations) pro&ide a short des"ription) root "ause and ;5P5 1Ta#le =-34( "a#le $2
Critical +eviations
&o. !ort +escri*tion
"a#le $3
Root Cause
CP
tatus of +eviation Re*ort
CP
tatus of +eviation Re*ort
&on$Critical +eviations
&o. !ort +escri*tion
Root Cause
:. 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 C!an'e &o.
ummary of Process C!an'es C!an'e "y*e
!ort +escri*tion +ate of **roval
tatus Remar)
Product Quality Review [Product Name Dosage Strength Dosage Form] :.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 C!an'e &o.
ummary of nalytical C!an'es C!an'e "y*e
!ort +escri*tion
+ate of **roval
tatus Remar)
:.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 C!an'e &o.
ummary of *ecifications C!an'es C!an'e "y*e
!ort +escri*tion
+ate of **roval
tatus Remar)
:.4 -t!er C!an'es Pro&ide the su''ar! in ta#le $or'at 1Ta#le ?-74 or state that no other "hanges ha&e #een per$or'ed( "a#le 9$4 C!an'e &o.
ummary of -t!er C!an'es C!an'e "y*e
!ort +escri*tion
+ate of **roval
tatus Remar)
;. 0alidation Review 5ll &alidation a"ti&ities per$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(
Product Quality Review [Product Name Dosage Strength Dosage Form]
"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 "hanges and 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, 8tility
I+ E=ui*ment
Qualification tatus
C!an'e, +eviation
&ext Qualification
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'ent 1Ta#le 8@-84( "a#le 1<$1
Quality 'reement
&ame of Contractor, Reference ando> ffiliates
+ate of review 0alid ?es, &o
Remar)
12. Com*liance wit! )ey re'ulation attri#utes Pro&ide a state'ent on the status o$ "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"e gaps. 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
Product Quality Review [Product Name Dosage Strength Dosage Form]
The re&ie* o$ the site do"u'entation against registration dossiers *as per$or'ed and the gaps identi$ied are #eing re'ediated &ia "hange "ontrol s!ste'( "a#le 11$1 %anufacturi n' ite &ame
@ey Re'ulatory ttri#utes
6ocation
+escri*tion of +escri*tion Pac)a'in' !elf nalytical 6ocation %anufacturin' 6ocation of Process ite 6ife "est ite Process Controls
5ll in$or'ation regarding su#'itted) granted or re$used 'arketing authoriations and post'arketing "o''it'ents $or ne* 'arketing authoriations and &ariations to 'arketing authoriations should #e listed. The DR5 is responsi#le to pro&ide input regarding su#'itted) granted or re$used 'arketing authoriations and &ariations there o$( 12. Com*laints 12.1
"ec!nical Com*laints
ist all te"hni"al "o'plaints during the re&ie* period. ;on"lusion 'ade as a result o$ the in&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 %aterial %aterial &o. &ame &o.
12.2
atc! &o.
!ort Root +escri*tion Cause
CP
Conclusion
%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"h had #een done 1Ta#le 82-84( "a#le 13$1 atc! &o.
ummary of Returned Product "otal &um#er of Returned
Reason
Product Quality Review [Product Name Dosage Strength Dosage Form] 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
