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Good manufacturing practices for pharmaceuticals / (Record no. 5209)

000 -LEADER
fixed length control field 03187cam a22002657a 4500
020 ## - INTERNATIONAL STANDARD BOOK NUMBER
ISBN 0849339723
020 ## - INTERNATIONAL STANDARD BOOK NUMBER
ISBN 9780849339721
082 00 - DEWEY DECIMAL CLASSIFICATION NUMBER
Classification number 338.4/76151
245 00 - TITLE STATEMENT
Title Good manufacturing practices for pharmaceuticals /
250 ## - EDITION STATEMENT
Edition statement 6th ed.
260 ## - PUBLICATION, DISTRIBUTION, ETC. (IMPRINT)
Place of publication New York, NY :
Name of publisher Informa Healthcare,
Year of publication c2007.
300 ## - PHYSICAL DESCRIPTION
Number of Pages viii, 398 p. :
Other physical details ill. ;
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 Pharmaceutical industry
650 #0 - SUBJECT ADDED ENTRY--TOPICAL TERM
Topical Term Drugs
650 #2 - SUBJECT ADDED ENTRY--TOPICAL TERM
Topical Term Pharmaceutical Preparations
650 #2 - SUBJECT ADDED ENTRY--TOPICAL TERM
Topical Term Drug Industry
650 #2 - SUBJECT ADDED ENTRY--TOPICAL TERM
Topical Term Legislation, Drug.
650 #2 - SUBJECT ADDED ENTRY--TOPICAL TERM
Topical Term Quality Control.
650 #2 - SUBJECT ADDED ENTRY--TOPICAL TERM
Topical Term Technology, Pharmaceutical
700 1# - ADDED ENTRY--PERSONAL NAME
Personal name Nally, Joseph D.
856 41 - ELECTRONIC LOCATION AND ACCESS
Uniform Resource Identifier http://www.loc.gov/catdir/toc/fy0709/2007272501.html
856 42 - ELECTRONIC LOCATION AND ACCESS
Uniform Resource Identifier http://www.loc.gov/catdir/enhancements/fy0713/2007272501-d.html
942 ## - ADDED ENTRY ELEMENTS (KOHA)
Koha item type Books
Holdings
Withdrawn status Lost status Permanent Location Current Location Shelving location Date acquired Source of acquisition Full call number Accession Number Koha item type
    Institute of Pharmaceutical Sciences Institute of Pharmaceutical Sciences Book Cart 2023-05-12 Donated 338.4/76151 002590 Books
    Institute of Pharmaceutical Sciences Institute of Pharmaceutical Sciences Book Cart 2023-05-12 Donated 338.4/76151 002591 Books

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