MARC details
| 000 -LEADER |
|---|
| fixed length control field |
03163cam a22003974i 4500 |
| 001 - CONTROL NUMBER |
|---|
| control field |
12117435 |
| 005 - DATE AND TIME OF LATEST TRANSACTION |
|---|
| control field |
20210307113512.0 |
| 008 - FIXED-LENGTH DATA ELEMENTS--GENERAL INFORMATION |
|---|
| fixed length control field |
000724s2001 nyua b 001 0 eng |
| 010 ## - LIBRARY OF CONGRESS CONTROL NUMBER |
|---|
| LC control number |
00060188 |
| 020 ## - INTERNATIONAL STANDARD BOOK NUMBER |
|---|
| International Standard Book Number |
0824704258 (alk. paper) |
| 040 ## - CATALOGING SOURCE |
|---|
| Original cataloging agency |
DLC |
| Transcribing agency |
DLC |
| Modifying agency |
DLC |
| Description conventions |
rda |
| 042 ## - AUTHENTICATION CODE |
|---|
| Authentication code |
pcc |
| 043 ## - GEOGRAPHIC AREA CODE |
|---|
| Geographic area code |
n-us--- |
| 050 00 - LIBRARY OF CONGRESS CALL NUMBER |
|---|
| Classification number |
RS189 |
| Item number |
.W57 2000 |
| 082 00 - DEWEY DECIMAL CLASSIFICATION NUMBER |
|---|
| Classification number |
615.190685 |
| Edition number |
22 |
| Item number |
W.S.G |
| 100 1# - MAIN ENTRY--PERSONAL NAME |
|---|
| Personal name |
Willig, Sidney H., |
| Dates associated with a name |
1919-, |
| Relator term |
author. |
| 245 10 - TITLE STATEMENT |
|---|
| Title |
Good manufacturing practices for pharmaceuticals : |
| Remainder of title |
a plan for total quality control from manufacturer to consumer / |
| Statement of responsibility, etc |
Sidney H. Willig. |
| 250 ## - EDITION STATEMENT |
|---|
| Edition statement |
Fifth edition, revised and expanded |
| 264 #1 - PUBLICATION, DISTRIBUTION, ETC. (IMPRINT) |
|---|
| Place of publication, distribution, etc |
New York : |
| Name of publisher, distributor, etc |
Marcel Dekker Inc., |
| Date of publication, distribution, etc |
[2001] |
| 264 #4 - PUBLICATION, DISTRIBUTION, ETC. (IMPRINT) |
|---|
| Date of publication, distribution, etc |
©2001 |
| 300 ## - PHYSICAL DESCRIPTION |
|---|
| Extent |
xii, 732 pages : |
| Other physical details |
illustrations (black and white); |
| Dimensions |
24 cm |
| 336 ## - CONTENT TYPE |
|---|
| Source |
rdacontent |
| Content type term |
text |
| 337 ## - MEDIA TYPE |
|---|
| Source |
rdamedia |
| Media type term |
unmediated |
| 338 ## - CARRIER TYPE |
|---|
| Source |
rdacarrier |
| Carrier type term |
volume |
| 490 1# - SERIES STATEMENT |
|---|
| Series statement |
Drugs and the pharmaceutical sciences ; |
| Volume number/sequential designation |
v. 109 |
| 504 ## - BIBLIOGRAPHY, ETC. NOTE |
|---|
| Bibliography, etc |
Includes bibliographical references and index. |
| 505 ## - FORMATTED CONTENTS NOTE |
|---|
| Formatted contents note |
Status and Applicability of U.S. Regulations: Current Good Manufacturing Practices in Manufacturing, Processing, Packaging, and Holdings of DrugsFinished Pharmaceuticals: General Provisions (Subpart A)Organization and Personnel: (Subpart B)Buildings and Facilities: (Subpart C)Equipment: (Subpart D)Control of Components and Drug Product Containers and Closures (Subpart E)Production and Process Controls (Subpart F)Packaging and Labeling Controls (Subpart G)Holding and Distribution: (Subpart H)Laboratory Controls (Subpart I)Records and Reports (Subpart J)Returned and Salvaged Drug Products (Subpart K)Repacking and RelabelingBulk Pharmaceutical ChemicalsThe Pharmacist and Total Quality ControlRecalls and CGMPs: Enforcement Alternatives in the United StatesControlled Substances Safeguards (21 CFR 1300, et seq.) The Inspection Procedure for Compliance in the United States: The Regulatee Is Inspected;The Rationale for Inspection (21 USC 373,374)FDA Pre-Approval Inspections/Investigations; The Road from SUPAC to the Food and Drug Modernization ActWho is the Manufacturer? Some Additional Considerations for the MultinationalOther GMPsOther Approaches to QualityImport and Export of Pharmaceuticals and Other ProductsSubject to CGMPsEnhancement of Global Product DistributionAppendix A: Food and Drug Modernization Act of 1997-in Pertinent PartAppendix B: Components/RepackagersAppendix C: Hearing Procedures When FDA Proposes the Imposition of Civil Money PenaltiesAppendix D:Section 601.12 Changes Currently Considered "Important" by CBERAppendix E: USP24-NF19 Information; Monographs; Tests |
| 650 #0 - SUBJECT ADDED ENTRY--TOPICAL TERM |
|---|
| Topical term or geographic name as entry element |
Pharmaceutical industry |
| General subdivision |
Quality control. |
| 650 #0 - SUBJECT ADDED ENTRY--TOPICAL TERM |
|---|
| Topical term or geographic name as entry element |
Drugs |
| General subdivision |
Standards |
| Geographic subdivision |
United States. |
| 830 #0 - SERIES ADDED ENTRY--UNIFORM TITLE |
|---|
| Title of a work |
Drugs and the pharmaceutical sciences |
| 856 42 - ELECTRONIC LOCATION AND ACCESS |
|---|
| Materials specified |
Publisher description |
| Uniform Resource Identifier |
<a href="http://www.loc.gov/catdir/enhancements/fy0647/00060188-d.html">http://www.loc.gov/catdir/enhancements/fy0647/00060188-d.html</a> |
| 906 ## - LOCAL DATA ELEMENT F, LDF (RLIN) |
|---|
| a |
7 |
| b |
cbc |
| c |
orignew |
| d |
1 |
| e |
ocip |
| f |
20 |
| g |
y-gencatlg |
| 942 ## - ADDED ENTRY ELEMENTS (KOHA) |
|---|
| Source of classification or shelving scheme |
Dewey Decimal Classification |
| Koha item type |
Books |