Documentation Basics That Support Good Manufacturing Practices and Quality System Regulations - Softcover

Carol DeSain

Softcover

ISBN 10: 097547720X ISBN 13: 9780975477205

Publisher: Tamarack Associates, LLC, 2004

Synopsis

Documentation Basics, second edition, includes everything you need to know about establishing a company-wide documentation system that meets GMP and QSR requirements. Documentation Basics, second edition, continues to provide - like the first edition - a minimum set of standards to consider when designing document identification numbering systems or writing standard operating procedures, specifications, quality manuals, logbooks, etc. Newly added features to the 2nd Edition are basic documentation practices for specific functional areas of operations such as Maintenance, Material Handling, Validation, Quality Control, Quality Assurance, and Production. In medical manufacturing environments, a sound, sensible and simple documentation system is the foundation of GMP. Using sample documents and simple, step-by-step instructions, this book outlines the major components of a documentation system, demonstrates how they interact and provides examples of their design, format and content. This comprehensive, hands-on guide will enable you to design an effective documentation system that ensures quality standards are met, minimizes errors, reduces downtime and serves as a training tool for line workers and administrators.

About this title

About the Author

Carol DeSain Carol DeSain’s consulting services focus on regulatory compliance for biologic, biotech, pharmaceutical, diagnostic, and combination products. She has worked in the industry for more than 25 years, with start-ups, global corporations, contract manufacturers, and allied industries in the U.S. and Europe. Carol helps her clients establish new systems, re-work failing systems, establish policy for global corporations and train management and staff. She is known for her broad knowledge of the industry, a practical, hands-on approach to compliance, interactive and informative training sessions, and for the books she has co-authored on documentation, risk management, validation and product development. Prior to consulting Carol worked in basic research (biochemistry, enzymology, and genetics), product/process development, and aseptic pharmaceutical manufacturing.

Edition details

• Publisher: Tamarack Associates, LLC
• Publication date: 2004
• Language: English
• ISBN 10: 097547720X
• ISBN 13: 9780975477205
• Binding: Paperback
• Number of pages: 131