Pharmaceutical manufacturing handbook regulations and quality

With its coverage of Food and Drug Administration regulations, international regulations, good manufacturing practices, and process analytical technology, this handbook offers complete coverage of the regulations and quality control issues that govern pharmaceutical manufacturing. In addition, the b...

Celý popis

Uložené v:
Podrobná bibliografia
Hlavný autor: Gad, Shayne Cox
Médium: E-kniha Kniha
Jazyk:English
Vydavateľské údaje: Hoboken, N.J Wiley-Interscience 2008
John Wiley & Sons, Incorporated
Wiley-Blackwell
Vydanie:1st ed.
Edícia:Pharmaceutical development series
Predmet:
Drug Evaluation > legislation & jurisprudence > United States
Drug Industry > legislation & jurisprudence > United States
Drugs > Law and legislation
Handbooks, manuals, etc
Law and legislation
Materia medica
Pharmaceutical industry
Pharmaceutical industry > Law and legislation > United States > Handbooks, manuals, etc
Pharmaceutical industry > Law and legislation
Pharmaceutical technology
Pharmaceutical technology > Quality control > Handbooks, manuals, etc
Pharmaceutical technology > Quality control
Pharmacy
Pharmacy > Law and legislation
Quality Control > United States
SCIENCE / Chemistry / Industrial & Technical
United States
ISBN:9780470259825, 9780470259597, 0470259590, 0470259825, 0470259833, 9780470259832
On-line prístup:Získať plný text
Tagy: Pridať tag
Žiadne tagy, Buďte prvý, kto otaguje tento záznam!
Abstract With its coverage of Food and Drug Administration regulations, international regulations, good manufacturing practices, and process analytical technology, this handbook offers complete coverage of the regulations and quality control issues that govern pharmaceutical manufacturing. In addition, the book discusses quality assurance and validation, drug stability, and contamination control, all key aspects of pharmaceutical manufacturing that are heavily influenced by regulatory guidelines. The team of expert authors offer you advice based on their own firsthand experience in all phases of pharmaceutical manufacturing.
AbstractList With its coverage of Food and Drug Administration regulations, international regulations, good manufacturing practices, and process analytical technology, this handbook offers complete coverage of the regulations and quality control issues that govern pharmaceutical manufacturing. In addition, the book discusses quality assurance and validation, drug stability, and contamination control, all key aspects of pharmaceutical manufacturing that are heavily influenced by regulatory guidelines. The team of expert authors offer you advice based on their own firsthand experience in all phases of pharmaceutical manufacturing.
Author Gad, Shayne Cox
Author_xml – sequence: 1
  fullname: Gad, Shayne Cox
BackLink https://cir.nii.ac.jp/crid/1130282270658382464$$DView record in CiNii
BookMark eNpdkL1PwzAQxY2giLZ0ZO8ASAwF--zE9kirApUqwYBATNHZcVqraVLiBMR_T0qR-Fju9KSf7t17PXJQlIUj5ITRS0YpXGmpqJAUIq047JHBLw3R_j_dIT2gVFHKpYgPSReYAMU01UdkEII3lDFQkYx0l5w9LLFao3VN7S3mwzUWTYa2bipfLIZLLFJTlqtj0skwD27wvfvk6Wb6OLkbze9vZ5Pr-QiFjkGMJCqrtJPaIkeDRqUxGgdKWsEgi53MpDSZVa07ZCZFl4GgSnJnDU1jaXifXOwOY1i597As8zokb7nbPhGSPyFb9nzHbqrytXGhTr4w64q6wjyZjiecc6m34OkOLLxPrN9OxjgFBSBpHCmuQMTix9svNo3JfVi2FSSbyq-x-kieZ_Ppy5i21Qmp-SfQLnGD
ContentType eBook
Book
DBID WIIVT
RYH
DEWEY 615.19
DOI 10.1002/9780470259832
DatabaseName Wiley
CiNii Complete
DatabaseTitleList

DeliveryMethod fulltext_linktorsrc
Discipline Medicine
Pharmacy, Therapeutics, & Pharmacology
EISBN 9780470259825
0470259825
Edition 1st ed.
1
ExternalDocumentID 9780470259825
EBC333795
BB08685005
WILEYB0011479
GroupedDBID 089
20A
38.
3VX
3X9
4ST
5VX
A4I
A4J
AABBV
AAIVD
ABARN
ABQPQ
ABQPW
ACLGV
ACYFF
ADVEM
AERYV
AHUFE
AHWGJ
AJFER
ALMA_UNASSIGNED_HOLDINGS
AZZ
BBABE
CZZ
DCRDY
DNKAV
EEHNK
HF4
J-X
MYL
PQQKQ
UQ7
W1A
WIIVT
RYH
ID FETCH-LOGICAL-a49624-7a8c89e79ca3abab8d6abe287c412f6e7f77bfc82852fbdaef240873ecb0d67b3
ISBN 9780470259825
9780470259597
0470259590
0470259825
0470259833
9780470259832
IngestDate Wed Oct 15 14:17:02 EDT 2025
Wed Nov 26 07:20:37 EST 2025
Thu Jun 26 21:08:57 EDT 2025
Fri Mar 21 18:58:22 EDT 2025
IsPeerReviewed false
IsScholarly false
LCCN 2008003746
LCCallNum RS192
LCCallNum_Ident RS192
Language English
LinkModel OpenURL
MergedId FETCHMERGED-LOGICAL-a49624-7a8c89e79ca3abab8d6abe287c412f6e7f77bfc82852fbdaef240873ecb0d67b3
Notes Includes bibliographical references and index
OCLC 214281909
PQID EBC333795
PageCount 858
ParticipantIDs askewsholts_vlebooks_9780470259825
proquest_ebookcentral_EBC333795
nii_cinii_1130282270658382464
igpublishing_primary_WILEYB0011479
ProviderPackageCode J-X
PublicationCentury 2000
PublicationDate 2008.
c2008
2008
2008-04-04
PublicationDateYYYYMMDD 2008-01-01
2008-04-04
PublicationDate_xml – year: 2008
  text: 2008.
PublicationDecade 2000
PublicationPlace Hoboken, N.J
PublicationPlace_xml – name: Hoboken, N.J
– name: Newark
PublicationSeriesTitle Pharmaceutical development series
PublicationYear 2008
Publisher Wiley-Interscience
John Wiley & Sons, Incorporated
Wiley-Blackwell
Publisher_xml – name: Wiley-Interscience
– name: John Wiley & Sons, Incorporated
– name: Wiley-Blackwell
SSID ssib011285759
ssib036179445
ssj0000220589
ssib013458559
Score 1.9752378
Snippet With its coverage of Food and Drug Administration regulations, international regulations, good manufacturing practices, and process analytical technology, this...
SourceID askewsholts
proquest
nii
igpublishing
SourceType Aggregation Database
Publisher
SubjectTerms Drug Evaluation -- legislation & jurisprudence -- United States
Drug Industry -- legislation & jurisprudence -- United States
Drugs--Law and legislation
Handbooks, manuals, etc
Law and legislation
Materia medica
Pharmaceutical industry
Pharmaceutical industry -- Law and legislation -- United States -- Handbooks, manuals, etc
Pharmaceutical industry--Law and legislation
Pharmaceutical technology
Pharmaceutical technology -- Quality control -- Handbooks, manuals, etc
Pharmaceutical technology--Quality control
Pharmacy
Pharmacy--Law and legislation
Quality Control -- United States
SCIENCE / Chemistry / Industrial & Technical
United States
SubjectTermsDisplay Drugs--Law and legislation
Materia medica
Pharmaceutical industry
Pharmaceutical industry--Law and legislation
Pharmaceutical technology
Pharmaceutical technology--Quality control
Pharmacy--Law and legislation
SCIENCE / Chemistry / Industrial & Technical
United States
Subtitle regulations and quality
TableOfContents Intro -- PHARMACEUTICAL MANUFACTURING HANDBOOK Regulations and Quality -- CONTRIBUTORS -- CONTENTS -- PREFACE -- SECTION 1 GOOD MANUFACTURING PRACTICES (GMP) AND OTHER FDA GUIDELINES -- 1.1 Good Manufacturing Practices (GMPs) and Related FDA Guidelines -- 1.2 Enforcement of Current Good Manufacturing Practices -- 1.3 Scale-Up and Postapproval Changes (SUPAC) Regulations -- 1.4 GMP-Compliant Propagation of Human Multipotent Mesenchymal Stromal Cells -- SECTION 2 INTERNATIONAL REGULATIONS OF GOOD MANUFACTURING PRACTICES -- 2.1 National GMP Regulations and Codes and International GMP Guides and Guildelines: Correspondences and Differences -- SECTION 3 QUALITY -- 3.1 Analytical and Computational Methods and Examples for Designing and Controlling Total Quality Management Pharmaceutical Manufacturing Systems -- 3.2 Role of Quality Systems and Audits in Phatmaceutical Manufacturing Environment -- 3.3 Creating and Managing a Quality Management System -- 3.4 Quality Process Improvement -- SECTION 4 PROCESS ANALYTICAL TECHNOLOGY (PAT) -- 4.1 Case for Process Analytical Technology: Regulatory and Industrial Perspectives -- 4.2 Process Analytical Technology -- 4.3 Chemical Imaging and Chemometrics: Useful Tools for Process Analytical Technology -- SECTION 5 PERSONNEL -- 5.1 Personnel Training in Pharmaceutical Manufacturing -- SECTION 6 CONTAMINATION AND CONTAMINATION CONTROL -- 6.1 Origin of Contamination -- 6.2 Quantitation of Markers for Gram-Negative and Gram-Positive Endotoxins in Work Environment and as Contaminants in Pharmaceutical Products Using Gas Chromatography-Tandem Mass Spectrometry -- 6.3 Microbiology of Nonsterile Pharmaceutical Manufacturing -- SECTION 7 DRUG STABILITY -- 7.1 Stability and Shelf Life of Pharmaceutical Products -- 7.2 Drug Stability -- 7.3 Effect of Packaging on Stability of Drugs and Drug Products
7.4 Pharmaceutical Product Stability -- 7.5 Alternative Accelerated Methods for Studying Drug Stability: Variable-Parameter Kinetics -- SECTION 8 VALIDATION -- 8.1 Analytical Method Validation: Principles and Practices -- 8.2 Analytical Method Validation and Quality Assurance -- 8.3 Validation of Laboratory Instruments -- 8.4 Pharmaceutical Manufacturing Validation Principles -- INDEX
Title Pharmaceutical manufacturing handbook
URI http://portal.igpublish.com/iglibrary/search/WILEYB0011479.html
https://cir.nii.ac.jp/crid/1130282270658382464
https://ebookcentral.proquest.com/lib/[SITE_ID]/detail.action?docID=333795
https://www.vlebooks.com/vleweb/product/openreader?id=none&isbn=9780470259825&uid=none
Volume 6
hasFullText 1
inHoldings 1
isFullTextHit
isPrint
link http://cvtisr.summon.serialssolutions.com/2.0.0/link/0/eLvHCXMwtV3Pb9MwFH6CwoGdGD9EgTELoZ0WkcZObHNBdBtCQqoqUU27RbZrs2oQqqab2v-eZ8dtmu2AduBiJZYVS-9z7OfPft8D-JCqgcqZtYnMLE-Y1S5RWthkmlqvVySUSV1INsFHI3FxIccxgVYd0gnwqhKrlZz_V6ixDsH2obP3gHv7UazAZwQdS4Qdy1se8fa1QXx82aGnf6vq2octNHGIniD37QMFsGgS0Ic7cJ44byIr23udDew_LtW68lntVh1qQNyiBsK8kgRmMS6nnc1jyjg6PDJv7sfemUobada2nYg8ZFedejjEPZHIg4zsQ9y69ODR6ej7l_MtzxUieYUMYgCxv3QjfLTpP2qfYtuPnf72YE_VVzjZ40KwrL2Y7M_5lpxDZ6Caze4socEvmDyFno8V2YcHtnoGRxGA9TGZtFFt9TE5IuNWIHz9HD53kSIdpMgGKfKJ7OBEsJZEnF7A-dezycm3JCaySBSTRcYSroQR0nJpFFUaf4ZpobTFzaphg8wVljvOtTNeTTBzeqqs88pznFqj02nBNX0JvepPZV8BsVoJ6zTzEqvMGipyVThGWap5wYzM-vB-x2blza9w6F6XO4bNcmy0a8py3iiblEHHfRgCrLnswwEauDQzXw78ATc6k_5UXFCRsYL14XBj-jJ0Eq8Tl2fDE0opl_nrf3zhDTxph-1b6C0X1_YAHpub5axevIsj6S_nmk4_
linkProvider ProQuest Ebooks
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%3Abook&rft.genre=book&rft.title=Pharmaceutical+manufacturing+handbook+%3A+regulations+and+quality&rft.au=Gad%2C+Shayne+Cox&rft.date=2008-01-01&rft.pub=Wiley-Interscience&rft.isbn=9780470259597&rft_id=info:doi/10.1002%2F9780470259832&rft.externalDocID=BB08685005
thumbnail_m http://cvtisr.summon.serialssolutions.com/2.0.0/image/custom?url=https%3A%2F%2Fvle.dmmserver.com%2Fmedia%2F640%2F97804702%2F9780470259825.jpg
thumbnail_s http://cvtisr.summon.serialssolutions.com/2.0.0/image/custom?url=http%3A%2F%2Fportal.igpublish.com%2Figlibrary%2Famazonbuffer%2FWILEYB0011479_null_0_320.png