MARC details
| 000 -LEADER |
|---|
| fixed length control field |
03062cam a22004334a 4500 |
| 001 - CONTROL NUMBER |
|---|
| control field |
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 |
| 020 ## - INTERNATIONAL STANDARD BOOK NUMBER |
|---|
| International Standard Book Number |
0849319943 (alk. paper) |
|
|---|
| International Standard Book Number |
9780849319945 |
| 035 ## - SYSTEM CONTROL NUMBER |
|---|
| System 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 |
| Item number |
SHG 2005 |
| Edition number |
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 |
|---|
| Formatted 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 |
TOC |
| 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 |
| 590 ## - LOCAL NOTE (RLIN) |
|---|
| Local note |
Abdul Gani |
| 650 #0 - SUBJECT ADDED ENTRY--TOPICAL TERM |
|---|
| Topical term or geographic name as entry element |
Drugs |
| General subdivision |
Standards |
| Geographic subdivision |
United States. |
| 9 (RLIN) |
8752 |
|
|---|
| Topical term or geographic name as entry element |
Drugs |
| General subdivision |
Standards |
| Geographic subdivision |
European Union Countries. |
| 9 (RLIN) |
9013 |
|
|---|
| Topical term or geographic name as entry element |
Pharmaceutical industry |
| Geographic subdivision |
United States |
| General subdivision |
Quality control. |
| 9 (RLIN) |
9014 |
|
|---|
| Topical term or geographic name as entry element |
Pharmaceutical industry |
| Geographic subdivision |
European Union Countries |
| General subdivision |
Quality control. |
| 9 (RLIN) |
9015 |
|
|---|
| Topical term or geographic name as entry element |
Drugs |
| General subdivision |
Law and legislation |
| Geographic subdivision |
United States. |
| 9 (RLIN) |
8534 |
|
|---|
| Topical term or geographic name as entry element |
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 |
Dewey Decimal Classification |
| Koha item type |
Text |