
By Brendan Cooper
Chapter 1: Facilities
Chapter 2: fresh Utilities
Chapter three: Sterile production Operations
Chapter four: Depyrogenation
Chapter five: cleansing and Disinfection
Chapter 6: method Development
Chapter 7: actual Processes
Chapter eight: gear Validation
Chapter nine: functionality Qualification
Chapter 10: GMP Basics
Chapter eleven: information Integrity
Glossary
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The Biotechnology HANDBOOK for Engineers' by Brendan Cooper
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