Good manufacturing practices for pharmaceuticals / edited by Graham P. Bunn

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