BioPharm International, September 2014 - BioPharm International

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BioPharm International, September 2014
Cover Story
Challenges and Trends in Biopharma Facility Design
By Susan Haigney
Experts discuss the future of modular manufacturing and the challenges that biopharma manufacturers face in facility design
Features
Assessing a Risk Management Program
By Michael J. Shea
Program review can help quality risk management live up to the promise of ICH Q9.
Minimizing Variation in Vial Withdrawal Practice
By Zack Marks
Vial adapters can reduce variation of volume withdrawn from injectable drug vials.
Optimizing Human Performance: A Road Worth Traveling, Part 3
By Gerry McAuley
This article is the third and final in a series designed to offer leaders and managers at all levels in the industry a road map to excellence in human performance and human error prevention.
Challenges of Protein Aggregation during Purification
By Cynthia Challener, PhD
Careful selection of downstream processing conditions is a must.
Regulatory Beat
Extending the Scope of Pharmacovigilance Comes at a Price
By Sean Milmo
As the pharmacovigilance infrastructure becomes more entrenched in Europe, drug manufacturers are beginning to feel the burden of its high cost.
Data Integrity Key to GMP Compliance
By Jill Wechsler
FDA demands accurate manufacturing and test information to ensure product quality.
Troubleshooting
Managing Cleaning Validation in Multi-Product Biologics Facilities
By Cynthia Challener, PhD
Developing and maintaining a current master plan for cleaning in multi-product facilities are crucial.
Perspectives on Outsourcing
Targeting Different Off-Shore Destinations
By Eric Langer
Annual study shows geographic proximity not a factor in CMO selection.
Analytical Best Practices
Evaluating Design Margin, Edge of Failure, and Process Capability
By Thomas A. Little, PhD
Design space generation is encouraged in new product development.
Compliance Notes
Quality Agreements for Contract Manufacturers
By Penny Hylton, PhD , David K. Haggard
A well-constructed quality agreement can be an important tool to enable effective collaboration between owner and CMO.
Global News
Healthcare Reform in China
By Jane Wan
Chinese healthcare reforms may be a double-edged sword for foreign companies.
Guest Editorial
The Relevance of Industry Technical Associations
By Hal Baseman
Industry associations play a strong role in helping the pharmaceutical industry meet challenges.

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