Sterile Manufacturing: Regulations, Processes, and Guidelines - Hardcover

by Sam A. Hout (Author)

This book highlights key ideas and factors to coach and guide professionals involved in learning about Sterile Manufacturing and operational requirements. It covers regulations and guidelines instituted by the FDA, ISPE, EMA, MHRA, and ICH, emphasizing good manufacturing practice and inspection requirements in the manufacturing of medicinal products.

Additionally, this book provides the fundamentals of aseptic techniques, quality by design, risk assessment, and management in support of sterile operations applications. It creates a link to the implementation of business practices in drug manufacturing and healthcare and forms a correlation between design strategies including a step-by-step process to ensure reliability, safety, and efficacy of healthcare products for human and animal use. The book also provides a connection between drug production and regulated applications by offering a review of the basic elements of sterile processing, and how to remain viable with solid strategic planning.

The book is a concise reference for professionals and learners in the field of sterile operations that governs primarily, pharmaceutical and medical device space, but can also extend to food and cosmetics that require clean (aseptic) manufacturing applications. It also helps compounding pharmacists and GMP inspectors and auditors.

Author 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.