1st Edition
Sterile Manufacturing Regulations, Processes, and Guidelines
Chapter 1 Introduction
Chapter 2 Data Integrity Compliance
Chapter 3 Risk-Based Life Cycle Management
Chapter 4 FMEA Manufacturing Procedure
Chapter 5 Classified Areas
Chapter 6 Sterile Manufacturing Facilities
Chapter 7 Personnel behaviors, Personal Protective Equipment (PPE), and
Process Flow
Chapter 8 Quality Approach for Systems Validation
Chapter 9 Dedicated Facilities
Chapter 10 Contamination
Chapter 11 Containment
Chapter 12 Suppliers
Chapter 13 Single-Use Technologies (SUT)
Chapter 14 Master Qualification Plan
Chapter 15 Water For Injection (WFI)
Chapter 16 Integrated Facility Design
Chapter 17 Sterile Techniques
Chapter 18 Compliance
Chapter 19 Controls
Chapter 20 Barriers and Isolators
Chapter 21 Quality Risk Management
Chapter 22 Equipment Qualification (EQ)
Chapter 23 Process Validation
Chapter 24 Change Control
Chapter 25 Analytical Testing of Raw Material Quality
Chapter 26 Product Life Cycle
Chapter 27 Quality by Design (QbD)
Chapter 28 Sterilization
Chapter 29 Cleaning Validation
Chapter 30 Lyophilization
Biography
Dr. Sam A. Hout is a chartered chemical engineer and certified in business management by the American Production and Inventory Control Society (APICS). He also is a member of the International Society of Pharmaceutical Engineers (ISPE) and specializes in process engineering and business process improvement. He received his education and training in the UK (Ph.D. Chemical Engineering, University of Bath) and in the United States (MBA, University of California). For the past 20 years in aseptic manufacturing, he held the position of Sr. Director of Engineering, project management, and technology process transfers at Siegfried Pharmaceuticals. Previously, he held the position of Sr. Manager of Engineering at TEVA Pharmaceuticals, parenteral medicines in Irvine, California. These specialty divisions produced sterile injectable drugs for hospital institutional markets worldwide.
