Sam A. Hout

Sterile Manufacturing (eBook, ePUB)

Regulations, Processes, and Guidelines

• Format: ePub

Produktbeschreibung

This book highlights key ideas and factors to coach and guide professionals involved in learning about Sterile Manufacturing and operational requirements.

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Produktdetails

• Verlag: Taylor & Francis
• Seitenzahl: 206
• Erscheinungstermin: 4. Juli 2021
• Englisch
• ISBN-13: 9781000406122
• Artikelnr.: 61762272

Autorenporträt

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.

Inhaltsangabe

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