Good manufacturing practices for pharmaceuticals / edited by Graham P. Bunn
Material type:
TextPublication details: Boca Raton, CRC Press : c2009. Description: xiii, 371 p. ; 26 cmISBN: 9781498732062Subject(s): Blended learning | Educational changeDDC classification: 338.476151 GOO
| Item type | Current library | Home library | Call number | Status | Date due | Barcode | Item holds |
|---|---|---|---|---|---|---|---|
English Lending
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Villa College Library | Villa College Library | 338.476151 GOO (Browse shelf(Opens below)) | Available | 14243 |
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| 338.433621 ECO Economic analysis in health care / | 338.433621 ECO Economic analysis in health care / | 338.47 ECO Economic analysis in health care / | 338.476151 GOO Good manufacturing practices for pharmaceuticals / | 338.4791 AHA Aharee report 2011 / | 338.4791 AHA Aharee report 2012 / | 338.4791 AHA Aharee report 2013 / |
CONTENT
CAPTER 1 Status and Applicability of U.S. Regulations: CGMP
CAPTER 2 Quality Management Systems and Risk Management
CAPTER 3 Management Responsibility and Control
CAPTER 4 Organization and Personnel
CAPTER 5 Finished Pharmaceuticals: General Provisions
CAPTER 6 Production and Process Controls
CAPTER 7 Records and Reports
CAPTER 8 Clinical Trial Supplies
CAPTER 9 Contracting and Outsourcing
CAPTER 10 Buildings and Facilities
CAPTER 11 Equipment
CAPTER 12 Control of Components and Drug Product Containers and Closures
CAPTER 13 Holding and Distribution
CAPTER 14 Returned and Salvaged Drug Products
CAPTER 15 Active Pharmaceutical Ingredients
CAPTER 16 Pharmaceutical Excipient Good Manufacturing Practices
CAPTER 17 Packaging and Labeling Control
CAPTER 18 Laboratory Controls
CAPTER 19 Microbiological Aspects of Pharmaceutical Aseptic Processing in the Compounding Pharmacy
CAPTER 20 CGMP Enforcement Alternatives in the United States
CAPTER 21 FDA Inspection Process
CAPTER 22 FDA Pre-approval Inspections
CAPTER 23 Worldwide Good Manufacturing Practices
CAPTER 24 Data Integrity and Fundamental Responsibilities
Includes bibliographical references and index
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