Good manufacturing practices for pharmaceuticals. (Record no. 25701)
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| 000 -LEADER | |
|---|---|
| fixed length control field | 03358nam a2200265Ia 4500 |
| 008 - FIXED-LENGTH DATA ELEMENTS--GENERAL INFORMATION | |
| fixed length control field | 250806s9999||||xx |||||||||||||| ||und|| |
| 020 ## - INTERNATIONAL STANDARD BOOK NUMBER | |
| International Standard Book Number | 9780849339721 (hardcover : alk. paper);0849339723 (hardcover : alk. paper) |
| 060 ## - NATIONAL LIBRARY OF MEDICINE CALL NUMBER | |
| Classification number | QV 771 |
| Item number | .G66 2007 |
| 245 #0 - TITLE STATEMENT | |
| Title | Good manufacturing practices for pharmaceuticals. |
| 250 ## - EDITION STATEMENT | |
| Edition statement | 6th ed. / |
| 260 ## - PUBLICATION, DISTRIBUTION, ETC. | |
| Place of publication, distribution, etc. | New York : |
| Name of publisher, distributor, etc. | Informa Healthcare, |
| Date of publication, distribution, etc. | c2007. |
| 300 ## - PHYSICAL DESCRIPTION | |
| Extent | 169 v. (viii, 398 p.) : |
| Other physical details | ill. |
| 490 ## - SERIES STATEMENT | |
| Series statement | Drugs and the pharmaceutical sciences, |
| 500 ## - GENERAL NOTE | |
| General note | Rev. ed. of: Good manufacturing practices for pharmaceuticals / Sidney H. Willig. 5th ed., rev. and expanded. |
| 504 ## - BIBLIOGRAPHY, ETC. NOTE | |
| Bibliography, etc. note | Includes bibliographical references and index. |
| 505 ## - 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 ## - SUBJECT ADDED ENTRY--TOPICAL TERM | |
| Topical term or geographic name entry element | Legislation, Drug |
| 650 ## - SUBJECT ADDED ENTRY--TOPICAL TERM | |
| Topical term or geographic name entry element | Technology, Pharmaceutical |
| 650 ## - SUBJECT ADDED ENTRY--TOPICAL TERM | |
| Topical term or geographic name entry element | Drug Industry |
| 650 ## - SUBJECT ADDED ENTRY--TOPICAL TERM | |
| Topical term or geographic name entry element | Pharmaceutical Preparations |
| 650 ## - SUBJECT ADDED ENTRY--TOPICAL TERM | |
| Topical term or geographic name entry element | Quality Control |
| 700 ## - ADDED ENTRY--PERSONAL NAME | |
| Personal name | Nally, Joseph D. |
| 700 ## - ADDED ENTRY--PERSONAL NAME | |
| Personal name | Willig, Sidney H., |
| 942 ## - ADDED ENTRY ELEMENTS (KOHA) | |
| -- | DIMC |
| Koha item type | Books |
| Date last seen | Total checkouts | Full call number | Barcode | Price effective from | Koha item type | Lost status | Damaged status | Not for loan | Withdrawn status | Home library | Current library | Date acquired |
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 08/06/2025 | QV 771 .G66 2007 | 00001775 | 08/06/2025 | Books | Dow International Medical College | Dow International Medical College | 08/06/2025 |