Good pharmaceutical manufacturing practice : (Record no. 5754)

000 -LEADER
fixed length control field 03062cam a22004334a 4500
001 - CONTROL NUMBER
EWU control number 5754
003 - CONTROL NUMBER IDENTIFIER
control field BD-DhEWU
005 - DATE AND TIME OF LATEST TRANSACTION
control field 20180109132520.0
008 - FIXED-LENGTH DATA ELEMENTS--GENERAL INFORMATION
fixed length control field 040507s2005 n a g b 001 0 eng
010 ## - LIBRARY OF CONGRESS CONTROL NUMBER
LC control number 2004050322
020 ## - INTERNATIONAL STANDARD BOOK NUMBER
International Standard Book Number 0849319943 (alk. paper)
International Standard Book Number 9780849319945
035 ## - SYSTEM CONTROL NUMBER
OCLC control number (OCoLC)
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 .S524 2005
082 00 - DEWEY DECIMAL CLASSIFICATION NUMBER
Classification number 615.362178273
Author mark and Year SHG 2005
DDC edition 22
100 1# - MAIN ENTRY--PERSONAL NAME
Personal name Sharp, John,
9 (RLIN) 9012
245 10 - TITLE STATEMENT
Title Good pharmaceutical manufacturing practice :
Remainder of title rationale and compliance /
Statement of responsibility, etc John Sharp.
260 ## - PUBLICATION, DISTRIBUTION, ETC. (IMPRINT)
Place of publication, distribution, etc New York :
Name of publisher, distributor, etc CRC Press,
Date of publication, distribution, etc c2005.
300 ## - PHYSICAL DESCRIPTION
Extent ix, 503 p. :
Other physical details ill. ;
Dimensions 26 cm.
504 ## - BIBLIOGRAPHY, ETC. NOTE
Bibliography, etc Includes bibliographical references and index.
505 ## - FORMATTED CONTENTS NOTE
Contents note Introduction: status and applicability of US regulations/EU guidelines - general quality issues --<br/>Personnel, organization, and training --<br/>Premises/buildings and facilities --<br/>Contamination and contamination control --<br/>Equipment --<br/>Materials control --<br/>Production and process controls --<br/>Packaging and labeling control --<br/>Holding and distribution --<br/>Laboratory controls --<br/>Records and reports --<br/>Returned and salvaged drug products --<br/>Sterile products manufacture - basic principles --<br/>GMP and quality assurance in sterile products manufacture --<br/>Validation - general principles --<br/>Validation - applications --<br/>Self-inspection and quality audit --<br/>US cGMPs and EC GMP guide - concluding comparison.
Title Table of contents
520 ## - SUMMARY, ETC.
Summary, etc Bridging the gap between U.S. regulations and European Good Manufacturing Practice guidelines, Good Pharmaceutical Manufacturing Practice: Rationale and Compliance gleans the most important substance from the U.S. Current Good Manufacturing Practice, parts 210 and 211 (US cGMPs, 2002) and the European Guide to Good Manufacturing Practice for Medicinal Products for Human and Veterinary Use (EU GMP Guide, 2002). The author uses his 40+ years of experience in technical management, production, quality assurance, and distribution within the pharmaceutical industry, offering a hands-on guide to better understand and implement optimal pharmaceutical practices."--BOOK JACKET.
526 ## - STUDY PROGRAM INFORMATION NOTE
Program name Pharmacy
650 #0 - SUBJECT ADDED ENTRY--TOPICAL TERM
Topical term or geographic name Drugs
General subdivision Standards
Geographic subdivision United States.
9 (RLIN) 8752
Topical term or geographic name Drugs
General subdivision Standards
Geographic subdivision European Union Countries.
9 (RLIN) 9013
Topical term or geographic name Pharmaceutical industry
Geographic subdivision United States
General subdivision Quality control.
9 (RLIN) 9014
Topical term or geographic name Pharmaceutical industry
Geographic subdivision European Union Countries
General subdivision Quality control.
9 (RLIN) 9015
Topical term or geographic name Drugs
General subdivision Law and legislation
Geographic subdivision United States.
9 (RLIN) 8534
Topical term or geographic name Drugs
General subdivision Law and legislation
Geographic subdivision European Union Countries.
9 (RLIN) 9016
856 42 - ELECTRONIC LOCATION AND ACCESS
Materials Specified Publisher description
Uniform Resource Identifier http://www.loc.gov/catdir/enhancements/fy0646/2004050322-d.html
Materials Specified WorldCat details
Uniform Resource Identifier http://www.worldcat.org/title/good-pharmaceutical-manufacturing-practice-rationale-and-compliance/oclc/55149519&referer=brief_results
Materials Specified E-book Fulltext
Uniform Resource Identifier http://lib.ewubd.edu/ebook/5754
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 Total Checkouts Checked out Date last seen Date checked out
    Not For Loan Non-fiction EWU Library EWU Library Reserve Section 2008-01-27 Paragon Enterprises Ltd. 15990.00 615.362178273 SHG 2005 21430 C-1 Text        
      Non-fiction EWU Library EWU Library Circulation Section 2008-01-27 Bangaldesh Photostat 632.00 615.362178273 SHG 2005 21431 C-2 Text        
      Non-fiction EWU Library EWU Library Circulation Section 2008-01-27 Bangaldesh Photostat 632.00 615.362178273 SHG 2005 21432 C-3 Text 5 2019-12-17 2019-11-11 2019-11-11
      Non-fiction EWU Library EWU Library E-book 2017-12-06     615.362178273 SHG 2005     E-Book     2017-12-06  

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