Process validation in manufacturing of biopharmaceuticals / (Record no. 573598)

MARC details
000 -LEADER
fixed length control field 03448cam a2200481 a 4500
005 - DATE AND TIME OF LATEST TRANSACTION
control field 20250918235615.0
008 - FIXED-LENGTH DATA ELEMENTS--GENERAL INFORMATION
fixed length control field 140702s2012 flua b 001 0 eng
020 ## - INTERNATIONAL STANDARD BOOK NUMBER
International Standard Book Number 9781439850930 (hardcover : alk. paper)
Terms of availability RM632.80
020 ## - INTERNATIONAL STANDARD BOOK NUMBER
International Standard Book Number 1439850933 (hardcover : alk. paper)
020 ## - INTERNATIONAL STANDARD BOOK NUMBER
International Standard Book Number 9781439850947 (ebook)
020 ## - INTERNATIONAL STANDARD BOOK NUMBER
International Standard Book Number 1439850941 (ebook)
039 #9 - LEVEL OF BIBLIOGRAPHIC CONTROL AND CODING DETAIL [OBSOLETE]
Level of rules in bibliographic description 201509141149
Level of effort used to assign nonsubject heading access points ruzini
Level of effort used to assign subject headings 201504280922
Level of effort used to assign classification zainol
Level of effort used to assign subject headings 201409121127
Level of effort used to assign classification zainol
y 07-02-2014
z fida
040 ## - CATALOGING SOURCE
Modifying agency UKM
Description conventions rda
090 ## - LOCALLY ASSIGNED LC-TYPE CALL NUMBER (OCLC); LOCAL CALL NUMBER (RLIN)
Classification number (OCLC) (R) ; Classification number, CALL (RLIN) (NR) QV38.P963 2012 9
090 ## - LOCALLY ASSIGNED LC-TYPE CALL NUMBER (OCLC); LOCAL CALL NUMBER (RLIN)
Classification number (OCLC) (R) ; Classification number, CALL (RLIN) (NR) QV38
Local cutter number (OCLC) ; Book number/undivided call number, CALL (RLIN) .P963 2012 9
245 00 - TITLE STATEMENT
Title Process validation in manufacturing of biopharmaceuticals /
Statement of responsibility, etc. edited by Anurag G. Rathore, Gail Sofer.
250 ## - EDITION STATEMENT
Edition statement 3rd ed.
264 #1 - PRODUCTION, PUBLICATION, DISTRIBUTION, MANUFACTURE, AND COPYRIGHT NOTICE
Place of production, publication, distribution, manufacture Boca Raton, FL :
Name of producer, publisher, distributor, manufacturer CRC Press/Taylor & Francis,
Date of production, publication, distribution, manufacture, or copyright notice 2012.
264 #4 - PRODUCTION, PUBLICATION, DISTRIBUTION, MANUFACTURE, AND COPYRIGHT NOTICE
Date of production, publication, distribution, manufacture, or copyright notice ©2012
300 ## - PHYSICAL DESCRIPTION
Extent xvii, 513 pages :
Other physical details illustration ;
Dimensions 25 cm.
336 ## - CONTENT TYPE
Content type term text
Source rdacontent
337 ## - MEDIA TYPE
Media type term unmediated
Source rdamedia
338 ## - CARRIER TYPE
Carrier type term volume
Source rdacarrier
490 1# - SERIES STATEMENT
Series statement Biotechnology and bioprocessing series ;
Volume/sequential designation 35
505 0# - FORMATTED CONTENTS NOTE
Formatted contents note Guidelines to process validation / Gail Sofer -- Commentary on the US Food and Drug Administration's 2011'Guidance for industry, process validation general principles and practices' / Hal Baseman -- Applications of failure modes and effects analysis to biotechnology manufacturing processes / Robert J. Seely and John Haury -- Process characterization / James E. Seely -- Scale-down models for purification processes : approaches and applications / Ranga Godavarti ... [et al.] -- Adventitious agents : concerns and testing for biopharmaceuticals / Raymond W. Nims ... [et al.] -- Lifespan studies for chromatography and filtration media / Anurag Rathore and Carol Sofer -- Validation of a filtration step / Jennifer Campbell -- Analytical test methods for well-characterized biological and biotechnological products / Nadine Ritter and John McEntire -- Facility design issues : a regulatory perspective / Sue Vargo and Nancy Kavanaugh -- Validation of computerized systems / Monica J. Cahilly -- Process validation with a CMO / Susan Dana Jones, Sheila G. Magil, and Gail Sofer -- Risk management and validation / James Agalloco -- Process validation in membrane chromatography / Suma Ray and Miyako Hirai -- Leveraging multivariate analysis tools to qualify scaled-down models / John Pieracci and Helena Yusuf-Makagiansar -- Process validation of a multivalent bacterial vaccine : a novel matrix approach / Narahari S. Pujar ... [et al.] -- Validation of the Zevalin purification process : a case study / Lynn Conley, John McPherson, and J诲g Th语mes -- Viral clearance validation : a case study / Michael Rubino ... [et al.].
650 #2 - SUBJECT ADDED ENTRY--TOPICAL TERM
Topical term or geographic name entry element Biopharmaceutics.
650 #2 - SUBJECT ADDED ENTRY--TOPICAL TERM
Topical term or geographic name entry element Biotechnology.
650 #2 - SUBJECT ADDED ENTRY--TOPICAL TERM
Topical term or geographic name entry element Drug Approval.
650 #2 - SUBJECT ADDED ENTRY--TOPICAL TERM
Topical term or geographic name entry element Quality control.
650 #7 - SUBJECT ADDED ENTRY--TOPICAL TERM
Topical term or geographic name entry element Biotechnological process monitoring.
Source of heading or term fast
Authority record control number or standard number (OCoLC)fst00832727
650 #7 - SUBJECT ADDED ENTRY--TOPICAL TERM
Topical term or geographic name entry element Pharmaceutical biotechnology
General subdivision Quality control.
Source of heading or term fast
Authority record control number or standard number (OCoLC)fst01060109
700 1# - ADDED ENTRY--PERSONAL NAME
Personal name Rathore, Anurag S.
Fuller form of name (Anurag Singh),
Dates associated with a name 1973-
Relator term editor
700 1# - ADDED ENTRY--PERSONAL NAME
Personal name Sofer, G. K.
Relator term editor
830 #0 - SERIES ADDED ENTRY--UNIFORM TITLE
Uniform title Biotechnology and bioprocessing series ;
Volume/sequential designation 35.
907 ## - LOCAL DATA ELEMENT G, LDG (RLIN)
a .b1594198x
b 2019-11-12
c 2019-11-12
942 ## - ADDED ENTRY ELEMENTS (KOHA)
Koha item type AM
Suppress in OPAC No
Call number prefix QV38.P963 2012 9
914 ## - VTLS Number
VTLS Number vtls003563997
990 ## - EQUIVALENCES OR CROSS-REFERENCES [LOCAL, CANADA]
Link information for 9XX fields zr
991 ## - LOCAL NOTE (NAMA FAKULTI/INSTITUT/PUSAT)
a Fakulti Farmasi, KKL
998 ## - LOCAL CONTROL INFORMATION (RLIN)
Library PERPUSTAKAAN DR ABDUL LATIFF
Operator's initials, OID (RLIN) 2014-02-07
Cataloger's initials, CIN (RLIN) m
Material Type (Sierra) Printed Books
Language English
Country
-- 0
-- .b1594198x
Holdings
Withdrawn status Lost status Damaged status Not for loan Home library Current library Shelving location Date acquired Source of acquisition Cost, normal purchase price Inventory number Total checkouts Full call number Barcode Date last seen Copy number Price effective from Koha item type Materials specified (bound volume or other part)
        PERPUSTAKAAN DR ABDUL LATIFF PERPUSTAKAAN DR ABDUL LATIFF KOLEKSI AM-P. DR ABDUL LATIFF 12/11/2019 - 601.16 .i20564533   QV38.P963 2012 9 00002101028 18/09/2025 1 18/09/2025 AM  
        PERPUSTAKAAN DR ABDUL LATIFF PERPUSTAKAAN DR ABDUL LATIFF KOLEKSI AM-P. DR ABDUL LATIFF 12/11/2019 - 590.43 .i20564545   QV38.P963 2012 9 00002123138 18/09/2025 1 18/09/2025 AM n.2

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