Pharmaceutical process validation / (Record no. 4428)

000 -LEADER
fixed length control field 02927cam a2200457 a 4500
001 - CONTROL NUMBER
EWU control number 4428
003 - CONTROL NUMBER IDENTIFIER
control field BD-DhEWU
005 - DATE AND TIME OF LATEST TRANSACTION
control field 20171217115112.0
008 - FIXED-LENGTH DATA ELEMENTS--GENERAL INFORMATION
fixed length control field 031029s2003 nyua g b 001 0 eng d
010 ## - LIBRARY OF CONGRESS CONTROL NUMBER
LC control number 2003279593
020 ## - INTERNATIONAL STANDARD BOOK NUMBER
International Standard Book Number 0824708385 (alk. paper)
International Standard Book Number 9780824708382
035 ## - SYSTEM CONTROL NUMBER
OCLC control number (OCoLC)54001293
040 ## - CATALOGING SOURCE
Original cataloging agency DLC
Transcribing agency DLC
Modifying agency DLC
-- BD-DhEWU
Language of cataloging eng
041 ## - LANGUAGE CODE
Language code of text/sound track or separate title eng
050 00 - LIBRARY OF CONGRESS CALL NUMBER
Classification number RS189
Item number .P46 2003
082 04 - DEWEY DECIMAL CLASSIFICATION NUMBER
Classification number 615.1
Author mark and Year PHA 2003
245 00 - TITLE STATEMENT
Title Pharmaceutical process validation /
Statement of responsibility, etc edited by Robert A. Nash, Alfred H. Wachter.
250 ## - EDITION STATEMENT
Edition statement International 3rd ed., rev. and expanded.
260 ## - PUBLICATION, DISTRIBUTION, ETC. (IMPRINT)
Place of publication, distribution, etc New York :
Name of publisher, distributor, etc Marcel Dekker,
Date of publication, distribution, etc c2003.
300 ## - PHYSICAL DESCRIPTION
Extent xxxvi, 860 p. :
Other physical details ill. ;
Dimensions 24 cm.
490 1# - SERIES STATEMENT
Series statement Drugs and the pharmaceutical sciences ;
Volume number/sequential designation 129
504 ## - BIBLIOGRAPHY, ETC. NOTE
Bibliography, etc Includes bibliographical references and index.
505 ## - FORMATTED CONTENTS NOTE
Title Table of contents
Contents note Regulatory basis for process validation --<br/>Prospective process validation --<br/>Retrospective validation --<br/>Sterilization validation --<br/>Validation of solid dosage forms --<br/>Validation for medical devices --<br/>Validation of biotechnology processes --<br/>Transdermal process validation --<br/>Validation of lyophilization --<br/>Validation of inhalation aerosols --<br/>Process validation of phamaceutical ingredients --<br/>Qualification of water and air handling systems --<br/>Equipment and facility qualification --<br/>Validation and verification of cleaning processes --<br/>Validation of analytical methods and processes --<br/>Computer system validation: controlling the manufacturing process --<br/>Integrated packaging validation --<br/>Analysis of retrospective production data using quality control charts --<br/>Statistical methods for uniformity and dissolution testing --<br/>Change control and SUPAC --<br/>Process validation and quality assurance --<br/>Validation in contract manufacturing --<br/>Terminology of nonaseptic proess validation --<br/>Harmonization GMPs, and validation.
520 ## - SUMMARY, ETC.
Summary, etc The third edition of this text contains additional chapters which cover troubleshooting procedures, validation in contract manufacturing and current harmonization trends
526 ## - STUDY PROGRAM INFORMATION NOTE
Program name Pharmacy
650 #0 - SUBJECT ADDED ENTRY--TOPICAL TERM
Topical term or geographic name Pharmaceutical industry
General subdivision Quality control.
9 (RLIN) 1081
Topical term or geographic name Drugs
General subdivision Standards
Geographic subdivision United States.
9 (RLIN) 8752
Topical term or geographic name Drug Evaluation
General subdivision standards
Geographic subdivision United States.
9 (RLIN) 16487
Topical term or geographic name Drug Industry
General subdivision standards
Geographic subdivision United States.
9 (RLIN) 16488
Topical term or geographic name Quality Control.
9 (RLIN) 16489
700 1# - ADDED ENTRY--PERSONAL NAME
Personal name Berry, Ira R.,
Dates associated with a name 1942-
9 (RLIN) 8535
Personal name Nash, Robert A.,
Dates associated with a name 1930-
9 (RLIN) 16490
830 #0 -
Uniform title Drugs and the pharmaceutical sciences ;
-- 21401
856 42 - ELECTRONIC LOCATION AND ACCESS
Materials Specified Publisher description
Uniform Resource Identifier http://www.loc.gov/catdir/enhancements/fy0647/2003279593-d.html
Materials Specified WorldCat details
Uniform Resource Identifier https://www.worldcat.org/title/pharmaceutical-process-validation/oclc/54001293&referer=brief_results
Materials Specified E-Book Fulltext
Uniform Resource Identifier http://lib.ewubd.edu/ebook/4428
942 ## - ADDED ENTRY ELEMENTS (KOHA)
Source of classification or shelving scheme
Koha item type Text
Holdings
Lost status Source of classification or shelving scheme Not for loan Collection code Permanent Location Current Location Shelving location Date of accession Source of acquisition Cost, normal purchase price Full call number Barcode Copy number Koha item type Date last seen Price effective from
    Not For Loan Non-fiction EWU Library EWU Library Reserve Section 2005-10-19 Karim International 3240.00 615.1 PHA 2003 16427 C-1 Text    
    Not For Loan Non-fiction EWU Library EWU Library Reserve Section 2005-10-19 Karim International 3240.00 615.1 PHA 2003 16428 C-2 Text    
      Non-fiction EWU Library EWU Library E-book 2017-12-17     615.1 PHA 2003     E-Book 2017-12-17 2017-12-17

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