MARC details
000 -LEADER |
fixed length control field |
02764pam a2200457 a 4500 |
001 - CONTROL NUMBER |
control field |
27037034 |
003 - CONTROL NUMBER IDENTIFIER |
control field |
OCoLC |
005 - DATE AND TIME OF LATEST TRANSACTION |
control field |
20210921172857.0 |
008 - FIXED-LENGTH DATA ELEMENTS--GENERAL INFORMATION |
fixed length control field |
921117s1993 nyua b 001 0 eng c |
010 ## - LIBRARY OF CONGRESS CONTROL NUMBER |
LC control number |
92049060 |
020 ## - INTERNATIONAL STANDARD BOOK NUMBER |
International Standard Book Number |
0824787773 (alk. paper) |
020 ## - INTERNATIONAL STANDARD BOOK NUMBER |
International Standard Book Number |
9780824787776 |
040 ## - CATALOGING SOURCE |
Original cataloging agency |
DNLM/DLC |
Transcribing agency |
DLC |
Modifying agency |
NLM |
-- |
WBN |
-- |
TMV |
-- |
WaOLN |
043 ## - GEOGRAPHIC AREA CODE |
Geographic area code |
n-us--- |
049 ## - LOCAL HOLDINGS (OCLC) |
Holding library |
LQIA |
082 0# - DEWEY DECIMAL CLASSIFICATION NUMBER |
Classification number |
615.19 |
245 00 - TITLE STATEMENT |
Title |
Pharmaceutical process validation / |
250 ## - EDITION STATEMENT |
Edition statement |
2nd ed., rev. & expanded. |
260 ## - PUBLICATION, DISTRIBUTION, ETC. |
Place of publication, distribution, etc. |
New York : |
Name of publisher, distributor, etc. |
Marcel Dekker, |
Date of publication, distribution, etc. |
c1993. |
300 ## - PHYSICAL DESCRIPTION |
Extent |
xli, 602 p. : |
Other physical details |
ill. ; |
Dimensions |
24 cm. |
336 ## - CONTENT TYPE |
Content type term |
text |
Source |
rdacontent |
337 ## - MEDIA TYPE |
Media type term |
unmediated |
Source |
rdamedia |
338 ## - CARRIER TYPE |
Carrier type term |
volume |
Source |
rdacarrier |
490 1# - SERIES STATEMENT |
Series statement |
Drugs and the pharmaceutical sciences ; |
Volume/sequential designation |
57 |
504 ## - BIBLIOGRAPHY, ETC. NOTE |
Bibliography, etc. note |
Includes bibliographical references and index. |
505 0# - FORMATTED CONTENTS NOTE |
Formatted contents note |
Regulatory basis for process validation / Bernard T. Loftus -- Organizing for validation / J. Patrick Jeater, Leo F. Cullen and G.J. Papariello -- Validation of sterile products / Michael J. Akers and Neil R. Anderson -- Sterile products validation / Karl L. Hofmann, Jr. -- Validation of solid dosage forms / Jeffrey S. Rudolph -- Process validation and quality assurance / Carl B. Rifino -- Prospective process validation / Allen Y. Chao ... [et al.] -- Retrospective process validation / Chester J. Trubinski -- Validation of water systems for sterile and nonsterile products / Ward M. Johnson -- Cleaning validation / Paul Y. McCormick and Leo F. Cullen -- Equipment validation / Bohdan M. Ferenc, Luanne Kot and Rodney Thomas -- Process validation of raw materials / Ira R. Berry -- Analytical methods validation / Louis A. Pasteelnick -- Computer systems validation / James E. Krueger and Jonathan Krueger -- Validation of lyophilized products / Edward H. Trappler -- Validation of inhalation aerosols / Scott Bozzone. |
505 0# - FORMATTED CONTENTS NOTE |
Formatted contents note |
(cont) Analysis of retrospective production data using quality control charts / Peter H. Cheng and John E. Dutt -- Multivariate graphical analysis in the validation of pharmaceutical products / Stephen T. Horhota -- Recent trends in process validation / John Y. Lee -- Validation terminology / Kenneth G. Chapman. |
590 ## - LOCAL NOTE (RLIN) |
a |
Edited by : James Swarbrick. |
650 #0 - SUBJECT ADDED ENTRY--TOPICAL TERM |
Topical term or geographic name entry element |
Pharmaceutical industry |
General subdivision |
Quality control. |
9 (RLIN) |
32739 |
650 #0 - SUBJECT ADDED ENTRY--TOPICAL TERM |
Topical term or geographic name entry element |
Drugs |
General subdivision |
Standards |
Geographic subdivision |
United States. |
650 #2 - SUBJECT ADDED ENTRY--TOPICAL TERM |
Topical term or geographic name entry element |
Drug Evaluation |
General subdivision |
standards |
Geographic subdivision |
United States. |
650 #2 - SUBJECT ADDED ENTRY--TOPICAL TERM |
Topical term or geographic name entry element |
Drug Industry |
General subdivision |
standards |
Geographic subdivision |
United States. |
650 #2 - SUBJECT ADDED ENTRY--TOPICAL TERM |
Topical term or geographic name entry element |
Quality Control. |
700 1# - ADDED ENTRY--PERSONAL NAME |
Personal name |
Berry, Ira R., |
Dates associated with a name |
1942- |
9 (RLIN) |
21840 |
700 1# - ADDED ENTRY--PERSONAL NAME |
Personal name |
Nash, Robert A., |
Dates associated with a name |
1930- |
9 (RLIN) |
15784 |
830 #0 - SERIES ADDED ENTRY--UNIFORM TITLE |
Uniform title |
Drugs and the pharmaceutical sciences ; |
Volume/sequential designation |
v. 57. |
9 (RLIN) |
8747 |
902 ## - LOCAL DATA ELEMENT B, LDB (RLIN) |
a |
150310 |
907 ## - LOCAL DATA ELEMENT G, LDG (RLIN) |
a |
.b10235048 |
b |
smmai |
c |
- |
942 ## - ADDED ENTRY ELEMENTS (KOHA) |
Suppress in OPAC |
0 |
998 ## - LOCAL CONTROL INFORMATION (RLIN) |
Operator's initials, OID (RLIN) |
1 |
Cataloger's initials, CIN (RLIN) |
990101 |
First Date, FD (RLIN) |
m |
Local |
a |
-- |
0 |