عنوان

Good manufacturing practices for pharmaceuticals

Standard Number

electronic

Title Proper

Good manufacturing practices for pharmaceuticals

Place of Publication, Distribution, etc.

New York, NY

Name of Publisher, Distributor, etc.

Informa Healthcare

Date of Publication, Distribution, etc.

2007

Specific Material Designation and Extent of Item

viii, 398 p. : ill. ; 26 cm

Series Title

Drugs and the pharmaceutical sciences,0630-3852 ;v. 961

Text of Note

Includes bibliographical references and index

Text of Note

edited by Joseph D. Nally

Text of Note

6th ed

Text of 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 -- 01. 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 -- 21. Returned and Salvaged Drug Products, Subpart K / Joseph D. Nally -- 31. Repacking and Relabeling / Joseph D. Nally -- 41. Quality Systems and Risk Management Approaches / Joseph D. Nally and Laura L. Nally -- 51. Clinical Trial Supplies and Current Good Manufacturing / Graham Bunn -- 61. Contracting and Outsourcing / Graham Bunn -- 71. Active Pharmaceutical Ingredients / P. Denis Celentano -- 81. Bulk Pharmaceutical Excipient GMPs / Irwin Silverstein -- 91. Recalls, Warning Letters, Seizures and Injunctions: CGMP Enforcement Alternatives in the United States / Joseph D. Nally -- 02. Control Substances Safeguards )12 CFR 0031, et seq.( / Joseph D. Nally -- 12. The Inspection Procedures for Compliance in the United States: The Regulatee is Inspected; The Rational for Inspection )12 USC 373, 473( / 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 -- 32. World-Wide Good Manufacturings Practices / Joseph D. Nally -- 42. Quality Approaches: ISO 0009, 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

Entry Element

Quality control ، Pharmaceutical industry

Entry Element

Standards ، Drugs - United States

Entry Element

standard ، Pharmaceutical Preparations

Entry Element

standard ، Drug Industry

Entry Element

، Legislation, Drug

Entry Element

، Quality Control

Entry Element

standard ، Technology, Pharmaceutical

Entry Element

، United States

Class number

Relator Code

TI

AU Nally, Joseph D

SE