Good manufacturing practices for pharmaceuticals / (Record no. 34828)
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| 000 -LEADER | |
|---|---|
| fixed length control field | 04037cam a22004457a 4500 |
| 001 - CONTROL NUMBER | |
| control field | 14781242 |
| 003 - CONTROL NUMBER IDENTIFIER | |
| control field | BD-DhUL |
| 005 - DATE AND TIME OF LATEST TRANSACTION | |
| control field | 20150121174605.0 |
| 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 |
| -- | BD-DhUL |
| 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 | 615.19 |
| Edition number | 22 |
| 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. |
| 365 ## - TRADE PRICE | |
| Price type code | IRS |
| Price amount | 4995 |
| 440 #0 - SERIES STATEMENT/ADDED ENTRY--TITLE | |
| Title | Drugs and the pharmaceutical sciences, |
| International Standard Serial Number | 0360-2583 ; |
| Volume/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 |
| Price effective from | Date last seen | Permanent Location | Not for loan | Date acquired | Source of classification or shelving scheme | Koha item type | Lost status | Withdrawn status | Copy number | Collection code | Damaged status | Shelving location | Barcode | Current Location | Full call number |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 2015-01-21 | 2015-01-21 | Dhaka University Science Library | 2011-06-14 | Books | 1 | Non Fiction | General Stacks | 459467 | Dhaka University Science Library | 615.19 GOO |