Pharmaceutical master validation plan : (Record no. 5224)

000 -LEADER
fixed length control field 02570cam a22003734a 4500
001 - CONTROL NUMBER
EWU control number 5224
003 - CONTROL NUMBER IDENTIFIER
control field BD-DhEWU
005 - DATE AND TIME OF LATEST TRANSACTION
control field 20190310093042.0
008 - FIXED-LENGTH DATA ELEMENTS--GENERAL INFORMATION
fixed length control field 070303s2002 flua g b 001 0 eng d
010 ## - LIBRARY OF CONGRESS CONTROL NUMBER
LC control number 2001048618
020 ## - INTERNATIONAL STANDARD BOOK NUMBER
International Standard Book Number 1574443305 (alk. paper)
International Standard Book Number 9781574443301
035 ## - SYSTEM CONTROL NUMBER
OCLC control number (OCLC)48093011
040 ## - CATALOGING SOURCE
Original cataloging agency DNLM/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 RS192
Item number .H3533 2002
060 10 - NATIONAL LIBRARY OF MEDICINE CALL NUMBER
Classification number QV 736
Item number H149p 2001
082 04 - DEWEY DECIMAL CLASSIFICATION NUMBER
Classification number 615.19021873
DDC edition
Author mark and Year HAP 2002
100 1# - MAIN ENTRY--PERSONAL NAME
Personal name Haider, Syed Imtiaz.
9 (RLIN) 8992
245 10 - TITLE STATEMENT
Title Pharmaceutical master validation plan :
Remainder of title the ultimate guide to FDA, GMP, and GLP compliance /
Statement of responsibility, etc Syed Imtiaz Haider.
260 ## - PUBLICATION, DISTRIBUTION, ETC. (IMPRINT)
Place of publication, distribution, etc Boca Raton :
Name of publisher, distributor, etc St. Lucie Press,
Date of publication, distribution, etc c2002.
300 ## - PHYSICAL DESCRIPTION
Extent xxxi, 176 p. :
Other physical details ill. ;
Dimensions 25 cm. +
504 ## - BIBLIOGRAPHY, ETC. NOTE
Bibliography, etc Includes bibliographical references and index.
505 ## - FORMATTED CONTENTS NOTE
Title Table of contents
Contents note Validation master plan approval page --<br/>1. Introduction --<br/>2. Concept of qualification/validation --<br/>3. Revalidation --<br/>4. Facility description --<br/>5. Description of building --<br/>6. Equipment description --<br/>7. HVAC description --<br/>8. Utilities descriptions --<br/>9. Validation program overview --<br/>10. Calibration program summary --<br/>11. Preventive maintenance program summary --<br/>12. Key standard operating procedures (SOPs) --<br/>13. Validation of building --<br/>14. Validation of utility systems --<br/>15. Process description for dry production facility: Building A --<br/>16. Process description for liquid and semisolid production facility: Building B --<br/>17. Process description for parenterals production facility: Building C --<br/>18. Qualification of process equipment --<br/>19. Validation of support processes --<br/>20. Quality assurance/control laboratory validation --<br/>21. cGMP procedures and programs --<br/>22. Validation schedule --<br/>23. Drawings for ABC pharmaceutical plant.
520 ## - SUMMARY, ETC.
Summary, etc Summary:<br/>This text provides the tools to minimize non-conformance, reduce rework and rejected lots, avoid recall lots, and more easily achieve new drug approval, satisfactory inspections, corporate legal Read more...<br/>
526 ## - STUDY PROGRAM INFORMATION NOTE
Program name Pharmacy
650 #0 - SUBJECT ADDED ENTRY--TOPICAL TERM
Topical term or geographic name Pharmaceutical technology
General subdivision Quality control.
9 (RLIN) 8993
Topical term or geographic name Pharmaceutical industry
General subdivision Quality control.
9 (RLIN) 1081
Topical term or geographic name Drug Industry
General subdivision standards.
9 (RLIN) 8640
856 42 - ELECTRONIC LOCATION AND ACCESS
Materials Specified WorldCat details
Uniform Resource Identifier http://www.worldcat.org/title/pharmaceutical-master-validation-plan-the-ultimate-guide-to-fda-gmp-and-glp-compliance/oclc/48093011&referer=brief_results
Materials Specified Ebook Fulltext
Uniform Resource Identifier http://lib.ewubd.edu/ebook/5224
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 2006-12-13 Karim International 5535.00 615.19021873 HAP 2002 19465 C-1 Text    
      Non-fiction EWU Library EWU Library Circulation Section 2006-12-13 Karim International 5535.00 615.19021873 HAP 2002 19466 C-2 Text    
      Non-fiction EWU Library EWU Library Circulation Section 2007-03-30 Karim International 5590.00 615.19021873 HAP 2002 20049 C-4 Text    
      Non-fiction EWU Library EWU Library Circulation Section 2006-12-13 Karim International 5535.00 615.19021873 HAP 2002 19467 C-3 Text    
      Non-fiction EWU Library EWU Library Circulation Section 2007-03-30 Karim International 5590.00 615.19021873 HAP 2002 20050 C-5 Text    
      Non-fiction EWU Library EWU Library Audio Visual 2007-03-30 Karim International   615.19021873 HAP 2002 CD-1156 C-4 CDs & DVDs 2014-12-01 2014-12-01
      Non-fiction EWU Library EWU Library Audio Visual 2007-03-30 Karim International   615.19021873 HAP 2002 CD-1153 C-1 CDs & DVDs 2014-12-01 2014-12-01
      Non-fiction EWU Library EWU Library Audio Visual 2007-03-30 Karim International   615.19021873 HAP 2002 CD-1157 C-5 CDs & DVDs 2014-12-01 2014-12-01
      Non-fiction EWU Library EWU Library Audio Visual 2007-03-30 Karim International   615.19021873 HAP 2002 CD-1155 C-3 CDs & DVDs 2014-12-01 2014-12-01
      Non-fiction EWU Library EWU Library Audio Visual 2007-03-30 Karim International   615.19021873 HAP 2002 CD-1154 C-2 CDs & DVDs 2014-12-01 2014-12-01
      Non-fiction EWU Library EWU Library E-book 2018-01-09     615.19021873 HAP 2002     E-Book 2018-01-09 2018-01-09

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