Biocontamination Control for Pharmaceuticals and Healthcare

Biocontamination Control for Pharmaceuticals and Healthcare, Second Edition outlines a biocontamination strategy that tracks bio-burden control and reduction at each transition in classified areas of a facility. The first edition of the book covers many of the aspects of the strategy, but the new official guidance signals that a roadmap is required to fully comply with its requirements. Completely updated with the newest version of the EU-GPM (EN17141), this new edition expands coverage of quality risk management and contains completely new examples to help professionals bridge the gap between regulation and implementation.

This book offers professionals in pharma quality control and related areas guidance on building a complete biocontamination strategy.

• Includes the most current regulations
• Contains three new chapters, including Application of Quality Risk Management and its Application in Biocontamination Control, Designing an Environmental Monitoring Programme, and Synthesis: An Anatomy of a Contamination Control Strategy
• Offers practical guidance on building a complete biocontamination strategy