Good Manufacturing Practices for Pharmaceuticals Graham P. Bunn (Editor)

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Product details:

• ISBN-10 ‏ : ‎ 1498732062
• ISBN-13 ‏ : ‎ 978-1498732062
• Author: Graham P. Bunn

This book provides insight into the world of pharmaceutical quality systems and the key elements that must be in place to change the business and organizational dynamics from task-oriented procedure-based cultures to truly integrated quality business systems that are self-detecting and correcting. Chapter flow has been changed to adopt a quality systems organization approach, and supporting chapters have been updated based on current hot topics including the impact of the worldwide supply chain complexity and current regulatory trends.

Key Features:

• Presents insight into the world of pharmaceutical quality systems
• Analyzes regulatory trends and expectations
• Includes approaches and practices used in the industry to comply with regulatory requirements
• Discusses recent worldwide supply chain issues
• Delivers valuable information to a worldwide audience regarding the current GMP practices in the industry

Table of contents:

Chapter 1 Status and Applicability of U.S. Regulations: CGMP

Chapter 2 Quality Management Systems and Risk Management

Chapter 3 Management Responsibility and Control

Chapter 4 Organization and Personnel

Chapter 5 Finished Pharmaceuticals: General Provisions

Chapter 6 Production and Process Controls

Chapter 7 Records and Reports

Chapter 8 Clinical Trial Supplies

Chapter 9 Contracting and Outsourcing

Chapter 10 Buildings and Facilities

Chapter 11 Equipment

Chapter 12 Control of Components and Drug Product Containers and Closures

Chapter 13 Holding and Distribution

Chapter 14 Returned and Salvaged Drug Products

Chapter 15 Active Pharmaceutical Ingredients

Chapter 16 Pharmaceutical Excipient Good Manufacturing Practices

Chapter 17 Packaging and Labeling Control

Chapter 18 Laboratory Controls

Chapter 19 Microbiological Aspects of Pharmaceutical Aseptic Processing in the Compounding Pharmacy

Chapter 20 CGMP Enforcement Alternatives in the United States

Chapter 21 FDA Inspection Process

Chapter 22 FDA Pre-approval Inspections

Chapter 23 Worldwide Good Manufacturing Practices

Chapter 24 Data Integrity and Fundamental Responsibilities

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