MARC details
| 000 -LEADER |
|---|
| fixed length control field |
02927cam a2200457 a 4500 |
| 001 - CONTROL NUMBER |
|---|
| control field |
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 |
| 020 ## - INTERNATIONAL STANDARD BOOK NUMBER |
|---|
| International Standard Book Number |
0824708385 (alk. paper) |
|
|---|
| International Standard Book Number |
9780824708382 |
| 035 ## - SYSTEM CONTROL NUMBER |
|---|
| System 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 |
| Item number |
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 |
TOC |
| Formatted 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 |
| 590 ## - LOCAL NOTE (RLIN) |
|---|
| Local note |
Sagar Shahanawaz |
| 650 #0 - SUBJECT ADDED ENTRY--TOPICAL TERM |
|---|
| Topical term or geographic name as entry element |
Pharmaceutical industry |
| General subdivision |
Quality control. |
| 9 (RLIN) |
1081 |
|
|---|
| 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 |
Drug Evaluation |
| General subdivision |
standards |
| Geographic subdivision |
United States. |
| 9 (RLIN) |
16487 |
|
|---|
| Topical term or geographic name as entry element |
Drug Industry |
| General subdivision |
standards |
| Geographic subdivision |
United States. |
| 9 (RLIN) |
16488 |
|
|---|
| Topical term or geographic name as entry element |
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 - SERIES ADDED ENTRY--UNIFORM TITLE |
|---|
| Uniform title |
Drugs and the pharmaceutical sciences ; |
| 9 (RLIN) |
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 |
Dewey Decimal Classification |
| Koha item type |
Text |