Part 3: Enhanced Approaches to the Development of the Control Strategy and its Implementation in the Manufacturing Process Description

A series of case histories from IQ consortium member companies will be presented to exemplify how the application of the ICH Q11 vision for enhanced Quality by Design (QbD) development of the active pharmaceutical ingredient (API) can lead to differentiated outcomes for elements such as the API supp...

Full description

Saved in:
Bibliographic Details
Published inJournal of pharmaceutical innovation Vol. 14; no. 1; pp. 1 - 14
Main Authors Popkin, Matt E., Omer, Batool Ahmed, Seibert, Kevin D., Luciani, Carla V., Srivastava, Sushil, Hobson, Lindsay, Lepore, John V.
Format Journal Article
LanguageEnglish
Published New York Springer US 15.03.2019
Subjects
Online AccessGet full text

Cover

Loading…
Abstract A series of case histories from IQ consortium member companies will be presented to exemplify how the application of the ICH Q11 vision for enhanced Quality by Design (QbD) development of the active pharmaceutical ingredient (API) can lead to differentiated outcomes for elements such as the API supply chain and control strategy, and how changes to such outcomes are managed over the lifecycle. A series of articles will address “flexibility” and look to provide recommendations for the further development of the ICH Q11 vision. The focus of this work will address flexibility associated with the “Enhanced Approaches to the Development of the Control Strategy and Its Implementation in the Manufacturing Process Description.”
AbstractList A series of case histories from IQ consortium member companies will be presented to exemplify how the application of the ICH Q11 vision for enhanced Quality by Design (QbD) development of the active pharmaceutical ingredient (API) can lead to differentiated outcomes for elements such as the API supply chain and control strategy, and how changes to such outcomes are managed over the lifecycle. A series of articles will address “flexibility” and look to provide recommendations for the further development of the ICH Q11 vision. The focus of this work will address flexibility associated with the “Enhanced Approaches to the Development of the Control Strategy and Its Implementation in the Manufacturing Process Description.”
Author Luciani, Carla V.
Popkin, Matt E.
Srivastava, Sushil
Lepore, John V.
Hobson, Lindsay
Seibert, Kevin D.
Omer, Batool Ahmed
Author_xml – sequence: 1
  givenname: Matt E.
  surname: Popkin
  fullname: Popkin, Matt E.
  email: matt.e.popkin@gsk.com
  organization: Product Development and Supply, GlaxoSmithKline Ltd
– sequence: 2
  givenname: Batool Ahmed
  surname: Omer
  fullname: Omer, Batool Ahmed
  organization: Product Development and Supply, GlaxoSmithKline Ltd
– sequence: 3
  givenname: Kevin D.
  surname: Seibert
  fullname: Seibert, Kevin D.
  organization: Small Molecule Design and Development, Eli Lilly and Co., Lilly Technology Center
– sequence: 4
  givenname: Carla V.
  surname: Luciani
  fullname: Luciani, Carla V.
  organization: Small Molecule Design and Development, Eli Lilly and Co., Lilly Technology Center
– sequence: 5
  givenname: Sushil
  surname: Srivastava
  fullname: Srivastava, Sushil
  organization: Chemical Development, Bristol-Myers Squibb Company
– sequence: 6
  givenname: Lindsay
  surname: Hobson
  fullname: Hobson, Lindsay
  organization: Chemical Development, Bristol-Myers Squibb Company
– sequence: 7
  givenname: John V.
  surname: Lepore
  fullname: Lepore, John V.
  organization: Chemical Process Development and Commercialization, Merck
BookMark eNp9kM1OwzAQhC0EEm3hAbj5BQJrx_kxt6oUqFREJeBsOc6mTdXake0i9QV4bpKWM6cdrWZGo29MLq2zSMgdg3sGUDwExrkoEmBlIlMBCb8gIyZTmZQg-GWvy4InGeNwTcYhbAEymQOMyM9K-0jTRzq3G20N1nTadd5ps8FAo6Nxg_QJv3Hnuj3aSF1zes2cjd7t6Ef0OuL6SLWtaRsDXey7HQ5OHVtnaWtP9jdtD4028eBbu6Yr7wyG0PcG49tuMN6Qq0bvAt7-3Qn5ep5_zl6T5fvLYjZdJoaXZUykFBKlQGhQZCYXacGBmcLkGVSQmrwSpTBpWpeVllWdFcCbOgOW5QUIDQjphLBzr_EuBI-N6ny71_6oGKgBpDqDVD1INYBUvM_wcyZ0w3z0ausO3vYz_wn9AupmeT8
CitedBy_id crossref_primary_10_1021_acs_cgd_0c01171
crossref_primary_10_1039_D1AN00985K
crossref_primary_10_1080_13102818_2019_1676169
crossref_primary_10_1021_acs_oprd_9b00170
Cites_doi 10.1021/acs.oprd.5b00158
10.1021/acs.oprd.6b00073
10.1021/op058014i
10.1021/op200362h
10.1021/op5003177
10.1021/ie071256h
10.1021/op9901801
10.1021/op4001127
10.1021/acs.oprd.6b00253
10.1021/op0100605
10.1021/op050133a
10.1021/acs.oprd.5b00146
10.1021/op3002646
10.1021/op500204z
10.1007/s12247-008-9028-0
ContentType Journal Article
Copyright Springer Science+Business Media, LLC, part of Springer Nature 2018
Copyright_xml – notice: Springer Science+Business Media, LLC, part of Springer Nature 2018
DBID AAYXX
CITATION
DOI 10.1007/s12247-018-9340-2
DatabaseName CrossRef
DatabaseTitle CrossRef
DatabaseTitleList
DeliveryMethod fulltext_linktorsrc
Discipline Economics
EISSN 1939-8042
EndPage 14
ExternalDocumentID 10_1007_s12247_018_9340_2
GroupedDBID ---
-56
-5G
-BR
-EM
-~C
.86
.VR
06C
06D
0R~
0VY
203
29L
29~
2J2
2JN
2JY
2KG
2KM
2LR
2~H
30V
4.4
406
408
40E
5GY
67N
67Z
6NX
8TC
95-
95.
95~
96X
AAAVM
AABHQ
AAFGU
AAHNG
AAIAL
AAJKR
AANZL
AARTL
AATNV
AATVU
AAUYE
AAWCG
AAYFA
AAYIU
AAYQN
AAYTO
ABDZT
ABECU
ABFGW
ABFTV
ABHLI
ABHQN
ABJNI
ABJOX
ABKAS
ABKCH
ABMNI
ABMQK
ABNWP
ABPLI
ABQBU
ABSXP
ABTEG
ABTHY
ABTKH
ABTMW
ABWNU
ABXPI
ACBMV
ACBRV
ACBYP
ACGFS
ACHSB
ACHXU
ACIGE
ACIPQ
ACKNC
ACMDZ
ACMLO
ACOKC
ACOMO
ACSNA
ACTTH
ACVWB
ACWMK
ADHHG
ADHIR
ADINQ
ADKNI
ADKPE
ADMDM
ADOXG
ADRFC
ADTPH
ADURQ
ADYFF
ADZKW
AEFTE
AEGAL
AEGNC
AEJHL
AEJRE
AENEX
AEOHA
AEPYU
AESKC
AESTI
AETLH
AEVLU
AEVTX
AEXYK
AFLOW
AFNRJ
AFQWF
AFWTZ
AFZKB
AGAYW
AGDGC
AGGBP
AGJBK
AGMZJ
AGQMX
AGWIL
AGWZB
AGYKE
AHAVH
AHBYD
AHYZX
AIAKS
AIIXL
AILAN
AIMYW
AITGF
AJDOV
AJRNO
AJZVZ
AKMHD
AKQUC
ALMA_UNASSIGNED_HOLDINGS
ALWAN
AMKLP
AMXSW
AMYLF
AMYQR
AOCGG
ARMRJ
ASPBG
AVWKF
AXYYD
AZFZN
B-.
BA0
BDATZ
BGNMA
CS3
CSCUP
DDRTE
DNIVK
DPUIP
EBLON
EBS
EIOEI
EJD
ESBYG
F5P
FEDTE
FERAY
FFXSO
FIGPU
FINBP
FNLPD
FRRFC
FSGXE
FWDCC
G-Y
G-Z
GGCAI
GGRSB
GJIRD
GNWQR
GQ6
GQ7
HF~
HG6
HLICF
HMJXF
HRMNR
HVGLF
IJ-
IKXTQ
IWAJR
IXD
IZQ
I~X
I~Z
J-C
J0Z
JBSCW
JZLTJ
KOV
KPH
LLZTM
M4Y
MA-
NPVJJ
NQJWS
NU0
O93
O9I
O9J
P2P
PF0
PT4
QOR
QOS
R89
R9I
ROL
RPX
RSV
S16
S27
S3A
S3B
SAP
SBL
SDH
SHX
SISQX
SNE
SNPRN
SNX
SOHCF
SOJ
SPISZ
SRMVM
SSLCW
SSXJD
STPWE
SZN
T13
TSG
TSK
TSV
TUC
U2A
U9L
UG4
UNUBA
UOJIU
UTJUX
UZXMN
VC2
VFIZW
W48
WK8
YLTOR
Z45
Z7U
Z7V
Z87
ZMTXR
ZOVNA
~A9
-Y2
2VQ
5VS
AACDK
AAJBT
AANXM
AARHV
AASML
AAYXX
AAYZH
ABAKF
ABULA
ACAOD
ACBXY
ACDTI
ACZOJ
AEBTG
AEFQL
AEKMD
AEMSY
AFBBN
AFGCZ
AGQEE
AGRTI
AHSBF
AIGIU
AJBLW
CAG
CITATION
COF
EN4
H13
HZ~
O9-
S1Z
SJYHP
ID FETCH-LOGICAL-c288t-9949e94e0fe45c6437201c7c650b03c6b484c33d8ba9bd5702fd50156704a0e03
IEDL.DBID AGYKE
ISSN 1872-5120
IngestDate Fri Nov 22 00:16:38 EST 2024
Sat Dec 16 12:07:26 EST 2023
IsPeerReviewed true
IsScholarly true
Issue 1
Keywords Design space
Manufacturing process description S2.2
CMC
Design of experiment (DoE)
Process
Models
Kinetics
Control strategy
Methods
ICH
Quality by design (QbD)
Language English
LinkModel DirectLink
MergedId FETCHMERGED-LOGICAL-c288t-9949e94e0fe45c6437201c7c650b03c6b484c33d8ba9bd5702fd50156704a0e03
PageCount 14
ParticipantIDs crossref_primary_10_1007_s12247_018_9340_2
springer_journals_10_1007_s12247_018_9340_2
PublicationCentury 2000
PublicationDate 3-15-2019
PublicationDateYYYYMMDD 2019-03-15
PublicationDate_xml – month: 03
  year: 2019
  text: 3-15-2019
  day: 15
PublicationDecade 2010
PublicationPlace New York
PublicationPlace_xml – name: New York
PublicationSubtitle From R&D to Market
PublicationTitle Journal of pharmaceutical innovation
PublicationTitleAbbrev J Pharm Innov
PublicationYear 2019
Publisher Springer US
Publisher_xml – name: Springer US
References Am EndeDCliffordPDeAntonisDSantamariaCBrenekSPreparation of grignard reactants: ftir and calorimetric investigation for safe scale upOrg. Proc. Res. Dev1999331932910.1021/op99018011:CAS:528:DyaK1MXktl2hsrY%3D
PolsterCColeKBurchamCCampbellBFrederickAHansenMHardingMHellerMMillerMPhillipsJPollockPZaborenkoNPilot-scale continuous production of LY2888721: amide formation and reactive crystallizationOrg Proc Res Dev2014181295130910.1021/op500204z1:CAS:528:DC%2BC2cXhslChtr7E
García-MuñozSLucianiCVaidyaramanSSeibertKDefinition of design spaces using mechanistic models and geometric projections of probability mapsOrg. Proc. Res. Dev.2015191012102310.1021/acs.oprd.5b001581:CAS:528:DC%2BC2MXhtFOlsLrE
ThomsonNSingerRSeibertKLucianiCSrivastavaSKiesmanWIrdamELeporeJSchenckLCase studies in development of drug substance control strategyOrg. Proc. Res. Dev.20151993594810.1021/acs.oprd.5b001461:CAS:528:DC%2BC2MXpsFaksbg%3D
HoekstraLVonkPHulshofLModeling the scale-up of contact drying processesOrg. Proc. Res. Dev.200610340941610.1021/op058014i1:CAS:528:DC%2BD28XjslKnsb4%3D
RathoreAVelayudhanAGuidelines for optimization and scale-up in preparative chromatographyBioPharm International20031634421:CAS:528:DC%2BD3sXht1yltr8%3D
The development of a control strategy for a final intermediate towards the preparation of a drug substance is described in Org. Process Res.Dev.2016, 20, 1781–1791 (published on October 7, 2016).
SeibertKSethuramanSMitchellJGriffithsKMcGarveyBThe use of routine process capability for the determination of process parameter criticality in small-molecule API synthesis: JPharm Innov2008310511210.1007/s12247-008-9028-0
Gonzalez-BobesFKoppNLiLDeerbergJSharmaPLeungSDaviesMBushJHammJHrytsakMScale-up of azide chemistry: a case studyOrg. Proc. Res. Dev.2012162051205710.1021/op30026461:CAS:528:DC%2BC38XhsVKmtb3I
Food and Drug Administration Code of Federal Regulations, Tittle 21, Volume 4 (21CFR210.3).
ZaborenkoNLynderRBradenTCampbellBHansenMJohnsonMDevelopment of pilot-scale continuous production of an LY2886721 starting material by packed-bed hydrogenolysisOrg. Proc. Res. Dev.2015191231124310.1021/op50031771:CAS:528:DC%2BC2MXhtlOjurvL
MitchellJAbhinavaKGriffithsKMcGarveyBSeibertKSethuramanSUnit operations characterization using historical manufacturing performanceInd Eng Chem Res2008476612662110.1021/ie071256h1:CAS:528:DC%2BD1cXpt1SnsL8%3D
AndersonNPractical use of continuous processing in developing and scaling up laboratory processesOrg. Proc. Res. Dev.2001561362110.1021/op01006051:CAS:528:DC%2BD3MXns12lu7c%3D
FigueroaIVaidyaramanSViswanathSModel-based scale-up and design space determination for a batch reactive distillation with a dean-stark trapOrg. Proc. Res. Dev.2013171300131010.1021/op40011271:CAS:528:DC%2BC3sXhtFCmu7vF
TanglerASzabadosEOvercoming problems at elaboration and scale-up of liquid-phase Pd/C mediated catalytic hydrogenations in pharmaceutical productionOrg. Process Res. Dev2016201246125110.1021/acs.oprd.6b000731:CAS:528:DC%2BC28XptVKkurg%3D
JohnsonMMaySCalvinJRemacleJStoutJDiseroadWZaborenkoNHaeberleBSunWMillerMBrennanJDevelopment and scale-up of a continuous, high-pressure, asymmetric hydrogenation reaction, workup, and isolationOrg. Proc. Res. Dev.2012161017103810.1021/op200362h1:CAS:528:DC%2BC38XmtFartL0%3D
ICH Q11 Q9 Guidelines.
CaygillGZanfirMGavriilidisAScalable reactor design for pharmaceuticals and fine chemicals production. 1: potential scale-up obstaclesOrg. Proc. Res. Dev20061053955210.1021/op050133a1:CAS:528:DC%2BD28XitVOjur4%3D
L Hoekstra (9340_CR8) 2006; 10
9340_CR18
K Seibert (9340_CR2) 2008; 3
M Johnson (9340_CR11) 2012; 16
S García-Muñoz (9340_CR17) 2015; 19
F Gonzalez-Bobes (9340_CR7) 2012; 16
9340_CR14
J Mitchell (9340_CR3) 2008; 47
D Am Ende (9340_CR4) 1999; 3
A Rathore (9340_CR16) 2003; 16
C Polster (9340_CR12) 2014; 18
9340_CR1
A Tangler (9340_CR9) 2016; 20
N Thomson (9340_CR15) 2015; 19
I Figueroa (9340_CR6) 2013; 17
N Zaborenko (9340_CR13) 2015; 19
N Anderson (9340_CR10) 2001; 5
G Caygill (9340_CR5) 2006; 10
References_xml – ident: 9340_CR1
– volume: 19
  start-page: 1012
  year: 2015
  ident: 9340_CR17
  publication-title: Org. Proc. Res. Dev.
  doi: 10.1021/acs.oprd.5b00158
  contributor:
    fullname: S García-Muñoz
– volume: 20
  start-page: 1246
  year: 2016
  ident: 9340_CR9
  publication-title: Org. Process Res. Dev
  doi: 10.1021/acs.oprd.6b00073
  contributor:
    fullname: A Tangler
– volume: 10
  start-page: 409
  issue: 3
  year: 2006
  ident: 9340_CR8
  publication-title: Org. Proc. Res. Dev.
  doi: 10.1021/op058014i
  contributor:
    fullname: L Hoekstra
– volume: 16
  start-page: 1017
  year: 2012
  ident: 9340_CR11
  publication-title: Org. Proc. Res. Dev.
  doi: 10.1021/op200362h
  contributor:
    fullname: M Johnson
– volume: 19
  start-page: 1231
  year: 2015
  ident: 9340_CR13
  publication-title: Org. Proc. Res. Dev.
  doi: 10.1021/op5003177
  contributor:
    fullname: N Zaborenko
– volume: 16
  start-page: 34
  year: 2003
  ident: 9340_CR16
  publication-title: BioPharm International
  contributor:
    fullname: A Rathore
– volume: 47
  start-page: 6612
  year: 2008
  ident: 9340_CR3
  publication-title: Ind Eng Chem Res
  doi: 10.1021/ie071256h
  contributor:
    fullname: J Mitchell
– volume: 3
  start-page: 319
  year: 1999
  ident: 9340_CR4
  publication-title: Org. Proc. Res. Dev
  doi: 10.1021/op9901801
  contributor:
    fullname: D Am Ende
– volume: 17
  start-page: 1300
  year: 2013
  ident: 9340_CR6
  publication-title: Org. Proc. Res. Dev.
  doi: 10.1021/op4001127
  contributor:
    fullname: I Figueroa
– ident: 9340_CR18
  doi: 10.1021/acs.oprd.6b00253
– volume: 5
  start-page: 613
  year: 2001
  ident: 9340_CR10
  publication-title: Org. Proc. Res. Dev.
  doi: 10.1021/op0100605
  contributor:
    fullname: N Anderson
– volume: 10
  start-page: 539
  year: 2006
  ident: 9340_CR5
  publication-title: Org. Proc. Res. Dev
  doi: 10.1021/op050133a
  contributor:
    fullname: G Caygill
– ident: 9340_CR14
– volume: 19
  start-page: 935
  year: 2015
  ident: 9340_CR15
  publication-title: Org. Proc. Res. Dev.
  doi: 10.1021/acs.oprd.5b00146
  contributor:
    fullname: N Thomson
– volume: 16
  start-page: 2051
  year: 2012
  ident: 9340_CR7
  publication-title: Org. Proc. Res. Dev.
  doi: 10.1021/op3002646
  contributor:
    fullname: F Gonzalez-Bobes
– volume: 18
  start-page: 1295
  year: 2014
  ident: 9340_CR12
  publication-title: Org Proc Res Dev
  doi: 10.1021/op500204z
  contributor:
    fullname: C Polster
– volume: 3
  start-page: 105
  year: 2008
  ident: 9340_CR2
  publication-title: Pharm Innov
  doi: 10.1007/s12247-008-9028-0
  contributor:
    fullname: K Seibert
SSID ssj0059600
Score 2.1785567
SecondaryResourceType review_article
Snippet A series of case histories from IQ consortium member companies will be presented to exemplify how the application of the ICH Q11 vision for enhanced Quality by...
SourceID crossref
springer
SourceType Aggregation Database
Publisher
StartPage 1
SubjectTerms Biochemical Engineering
Biomedical and Life Sciences
Biomedicine
Biotechnology
Industrial and Production Engineering
Pharmacology/Toxicology
Review Article
Title Part 3: Enhanced Approaches to the Development of the Control Strategy and its Implementation in the Manufacturing Process Description
URI https://link.springer.com/article/10.1007/s12247-018-9340-2
Volume 14
hasFullText 1
inHoldings 1
isFullTextHit
isPrint
link http://utb.summon.serialssolutions.com/2.0.0/link/0/eLvHCXMwlV3NT8IwFG8QDnrx24gfpAdPmpGydazzBgQkGogHSfC0tF0XCbEYNw76B_h3-1o2kKgHkp2Wl2Z7fV_de7_fELpiVKkQChEHrEk4lHPm8EaSOK5SQQAW5MXcgJMHw2Z_RO_H_riE3OWnCz2tFx1JG6hXWDdINmZKEvzTo8SBsFuB1GOcsdK6e37oFvHXh5rcwiBZAMeshrvsZf61yHo2Wm-F2gzT21ug_lJLTGgGS6b1eSbq8vM3beMGD7-PdvOCE7cWFnKASkofou0Cj5weoa9HsB7s3eKufrHjALiV84yrFGczDBUi_jFahGeJvdVZzLjjnN72A3Md40mWYss3_JpDmjSeaCs-4HpuQBQWFYlzeAKsu4xax2jU6z51-k7-dwZHuoxlThjSUIVUkURRX9r-H2nIQELJJ4gnm4IyKj0vZoKHIvYD4iaxb4DbAaGcKOKdoLKeaXWKcEBiGVC4hGCUxULwBM6ZKjTkZIpJWkXXxS5FbwsSjmhFt2xUG4FqI6PayK2im2IPotwf0_-lzzaSPkc78JKhmUFr-BeonL3P1SUUJZmogRX22u1hLbfGGtoaua1vSFXbMA
link.rule.ids 314,780,784,27924,27925,41081,41523,42150,42592,52111,52234
linkProvider Springer Nature
linkToHtml http://utb.summon.serialssolutions.com/2.0.0/link/0/eLvHCXMwlV07T8MwELZQO5SFN6I8PTCBUjmJ0zhsVdVS6EMMrVSmyHYcUSFSRNIBfgC_m4vjtBTBgJQpOlmOfb47677vC0KXjCoVQCFigTcJi3LOLG7HseUo5fvgQW7Ec3LycNTsTej91JsaHndaot3LlqSO1CuyG2SbHCYJB9SlxIK4W6WQsEgFVVu3j_1OGYA9KMo1D5L5cM-ynWUz87dB1tPRei9Up5juNhqXkyuQJc-NRSYa8uOHbuM_Z7-DtkzJiVuFj-yiDZXsoVrJSE730ecD-A92b3AnedKAANwySuMqxdkcQ42Iv4GL8DzWr9oFyh0bgdt3zJMIz7IUa8XhF0NqSvAs0eZDnixyGoXmRWJDUIBxl3HrAE26nXG7Z5n_M1jSYSyzgoAGKqCKxIp6UncAiS19CUWfIK5sCsqodN2ICR6IyPOJE0deTt32CeVEEfcQVZJ5oo4Q9kkkfQqPEIyySAgew01TBbk8mWKS1tFVuU3hayHDEa4El_OlDWFpw3xpQ6eOrss9CM2JTP-2Pv6X9QWq9cbDQTi4G_VP0CZ8cJAj0mzvFFWyt4U6gxIlE-fGJb8AMHjcnw
linkToPdf http://utb.summon.serialssolutions.com/2.0.0/link/0/eLvHCXMwlV07T8MwELYQSMCCeIry9MAEiuokTmOzVaVVebTqQKVukZ04ogNuRdKBP8Dv5uw4LZVgQMoUWZZ8Pt991t33GaEbRpXiAEQ88CbpUSGYJ_w89wKl4hg8KMyEIScPhq3-mD5Nool757Sou93rkmTFaTAqTbpszrO8uSK-QeYxLZNwWENKPIjBWyYTGUcfB-06FEcAzy0jksVw4_KDZVnztynWE9N6VdQmm94-2nMoEberbT1AG0ofop2aRFwcoa8RbDkO73FXv9kaPm47cXBV4HKGAdbhH_1AeJbbX52qMR07TdpPLHSGp2WBrUjwu-MhaTzVdvhA6IVhPlgqI3acAph3GWqO0bjXfe30PfekgpcGjJUe55QrThXJFY1SW7QjfhqngNMkCdOWpIymYZgxKbjMopgEeRYZtnVMqCCKhCdoU8-0OkU4JlkaU_ikZJRlUoocLoeKG0UxxVLaQLe1PZN5pZyRrDSSjfETMH5ijJ8EDXRXWzxxh6j4e_TZv0Zfo-3RQy95eRw-n6NdWC83PWR-dIE2y4-FugRQUcor6zjfEA_EIg
openUrl ctx_ver=Z39.88-2004&ctx_enc=info%3Aofi%2Fenc%3AUTF-8&rfr_id=info%3Asid%2Fsummon.serialssolutions.com&rft_val_fmt=info%3Aofi%2Ffmt%3Akev%3Amtx%3Ajournal&rft.genre=article&rft.atitle=Part+3%3A+Enhanced+Approaches+to+the+Development+of+the+Control+Strategy+and+its+Implementation+in+the+Manufacturing+Process+Description&rft.jtitle=Journal+of+pharmaceutical+innovation&rft.au=Popkin%2C+Matt+E.&rft.au=Omer%2C+Batool+Ahmed&rft.au=Seibert%2C+Kevin+D.&rft.au=Luciani%2C+Carla+V.&rft.date=2019-03-15&rft.pub=Springer+US&rft.issn=1872-5120&rft.eissn=1939-8042&rft.volume=14&rft.issue=1&rft.spage=1&rft.epage=14&rft_id=info:doi/10.1007%2Fs12247-018-9340-2&rft.externalDocID=10_1007_s12247_018_9340_2
thumbnail_l http://covers-cdn.summon.serialssolutions.com/index.aspx?isbn=/lc.gif&issn=1872-5120&client=summon
thumbnail_m http://covers-cdn.summon.serialssolutions.com/index.aspx?isbn=/mc.gif&issn=1872-5120&client=summon
thumbnail_s http://covers-cdn.summon.serialssolutions.com/index.aspx?isbn=/sc.gif&issn=1872-5120&client=summon