| 000 -LEADER |
|---|
| fixed length control field |
03957cam a22004337a 4500 |
| 001 - CONTROL NUMBER |
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| control field |
14781242 |
| 003 - CONTROL NUMBER IDENTIFIER |
|---|
| control field |
OSt |
| 005 - DATE AND TIME OF LATEST TRANSACTION |
|---|
| control field |
20160310102755.0 |
| 008 - FIXED-LENGTH DATA ELEMENTS--GENERAL INFORMATION |
|---|
| fixed length control field |
070323s2007 nyua b 001 0 eng d |
| 010 ## - LIBRARY OF CONGRESS CONTROL NUMBER |
|---|
| LC control number |
2007272501 |
| 020 ## - INTERNATIONAL STANDARD BOOK NUMBER |
|---|
| International Standard Book Number |
0849339723 |
| 020 ## - INTERNATIONAL STANDARD BOOK NUMBER |
|---|
| International Standard Book Number |
9780849339721 |
| 035 ## - SYSTEM CONTROL NUMBER |
|---|
| System control number |
(OCoLC)ocm78051859 |
| 040 ## - CATALOGING SOURCE |
|---|
| Original cataloging agency |
UNM |
| Transcribing agency |
UNM |
| Modifying agency |
BAKER |
| -- |
YDXCP |
| -- |
UAT |
| -- |
IXA |
| -- |
DLC |
| 042 ## - AUTHENTICATION CODE |
|---|
| Authentication code |
lccopycat |
| 050 00 - LIBRARY OF CONGRESS CALL NUMBER |
|---|
| Classification number |
RS189 |
| Item number |
.W57 2007 |
| 082 00 - DEWEY DECIMAL CLASSIFICATION NUMBER |
|---|
| Classification number |
338.4 |
| Edition number |
21 |
| Item number |
GOO |
| 245 00 - TITLE STATEMENT |
|---|
| Title |
Good manufacturing practices for pharmaceuticals / |
| Statement of responsibility, etc |
edited by Joseph D. Nally. |
| 250 ## - EDITION STATEMENT |
|---|
| Edition statement |
6th ed. |
| 260 ## - PUBLICATION, DISTRIBUTION, ETC. (IMPRINT) |
|---|
| Place of publication, distribution, etc |
New York, NY : |
| Name of publisher, distributor, etc |
Informa Healthcare, |
| Date of publication, distribution, etc |
c2007. |
| 300 ## - PHYSICAL DESCRIPTION |
|---|
| Extent |
viii, 398 p. : |
| Other physical details |
ill. ; |
| Dimensions |
26 cm. |
| 440 #0 - SERIES STATEMENT/ADDED ENTRY--TITLE |
|---|
| International Standard Serial Number |
0360-2583 ; |
| Volume number/sequential designation |
v. 169 |
| 504 ## - BIBLIOGRAPHY, ETC. NOTE |
|---|
| Bibliography, etc |
Includes bibliographical references and index. |
| 505 0# - FORMATTED CONTENTS NOTE |
|---|
| Formatted contents note |
Preface / Joseph D. Nally -- Contributors -- 1. Status and Applicability of U.S. Regulations: Current Good Manufacturing Practices in Manufacturing, Processing, Packaging, and Holding of Drugs / Joseph D. Nally -- 2. Finished Pharmaceuticals: General Provisions, Subpart A / Joseph D. Nally -- 3. Organization and Personnel, Subpart B / Joanne W. Cochran and Joseph D. Nally -- 4. Buildings and Facilities, Subpart C / Robert Del Ciello -- 5. Equipment, Subpart D / Robert Del Ciello, Joseph T. Busfield, and Steven Ostrove -- 6. Control of Components and Drug Product Containers and Closures , Subpart E / Arlyn R. Sibille -- 7. Production and Process Controls, Subpart F / Joseph D. Nally and Michael D. Karaim -- 8. Packaging and Labeling Control, Subpart G / Arlyn R. Sibille -- 9. Holding Distribution, Subpart H / Joseph D. Nally -- 10. Laboratory Controls, Subpart I / Wayne J. DeWitte and Lex M. Hoinowski -- 11. Records and Reports, Subpart J / Arlyn R. Sibille, Steven Ostrove, Joseph D. Nally, and Laura L. Nally -- 12. Returned and Salvaged Drug Products, Subpart K / Joseph D. Nally -- 13. Repacking and Relabeling / Joseph D. Nally -- 14. Quality Systems and Risk Management Approaches / Joseph D. Nally and Laura L. Nally -- 15. Clinical Trial Supplies and Current Good Manufacturing / Graham Bunn -- 16. Contracting and Outsourcing / Graham Bunn -- 17. Active Pharmaceutical Ingredients / P. Denis Celentano -- 18. Bulk Pharmaceutical Excipient GMPs / Irwin Silverstein -- 19. Recalls, Warning Letters, Seizures and Injunctions: CGMP Enforcement Alternatives in the United States / Joseph D. Nally -- 20. Control Substances Safeguards (21 CFR 1300, et seq.) / Joseph D. Nally -- 21. The Inspection Procedures for Compliance in the United States: The Regulatee is Inspected; The Rational for Inspection (21 USC 373, 374) / Joseph D. Nally -- 22. FDA Pre-Approval Inspections/Investigations: The Road from Scale-Up and Post-Approval Changes in the Food and Drug Modernization Act / Joseph D. Nally -- 23. World-Wide Good Manufacturings Practices / Joseph D. Nally -- 24. Quality Approaches: ISO 9000, Malcolm Baldrige, and Six Sigma / Joseph D. Nally -- Appendix A: Center for Drug Evaluation and Research: List of Guidance Documents -- Appendix B: ICH Guidelines -- Appendix C: Food and Drug Administration (FDA) Office Regulatory Affairs (ORA) Compliance Policy Guides -- Index. |
| 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. |
| 650 #2 - SUBJECT ADDED ENTRY--TOPICAL TERM |
|---|
| Topical term or geographic name as entry element |
Pharmaceutical Preparations |
| General subdivision |
standard. |
| 650 #2 - SUBJECT ADDED ENTRY--TOPICAL TERM |
|---|
| Topical term or geographic name as entry element |
Drug Industry |
| General subdivision |
standard. |
| 650 #2 - SUBJECT ADDED ENTRY--TOPICAL TERM |
|---|
| Topical term or geographic name as entry element |
Legislation, Drug. |
| 650 #2 - SUBJECT ADDED ENTRY--TOPICAL TERM |
|---|
| Topical term or geographic name as entry element |
Quality Control. |
| 650 #2 - SUBJECT ADDED ENTRY--TOPICAL TERM |
|---|
| Topical term or geographic name as entry element |
Technology, Pharmaceutical |
| General subdivision |
standard. |
| 651 #2 - SUBJECT ADDED ENTRY--GEOGRAPHIC NAME |
|---|
| Geographic name |
United States. |
| 700 1# - ADDED ENTRY--PERSONAL NAME |
|---|
| Personal name |
Nally, Joseph D. |
| 856 41 - ELECTRONIC LOCATION AND ACCESS |
|---|
| Materials specified |
Table of contents only |
| Uniform Resource Identifier |
http://www.loc.gov/catdir/toc/fy0709/2007272501.html |
| 856 42 - ELECTRONIC LOCATION AND ACCESS |
|---|
| Materials specified |
Publisher description |
| Uniform Resource Identifier |
http://www.loc.gov/catdir/enhancements/fy0713/2007272501-d.html |
| 906 ## - LOCAL DATA ELEMENT F, LDF (RLIN) |
|---|
| a |
7 |
| b |
cbc |
| c |
copycat |
| d |
2 |
| e |
ncip |
| f |
20 |
| g |
y-gencatlg |
| 942 ## - ADDED ENTRY ELEMENTS (KOHA) |
|---|
| Source of classification or shelving scheme |
|
| Koha item type |
Books |
