Optimizing Human Performance: A Road Worth Traveling, Part 3
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.
Healthcare Reform in China
Chinese healthcare reforms may be a double-edged sword for foreign companies.
Extending the Scope of Pharmacovigilance Comes at a Price
As the pharmacovigilance infrastructure becomes more entrenched in Europe, drug manufacturers are beginning to feel the burden of its high cost.
Targeting Different Off-Shore Destinations
Annual study shows geographic proximity not a factor in CMO selection.
Data Integrity Key to GMP Compliance
FDA demands accurate manufacturing and test information to ensure product quality.
Challenges of Protein Aggregation during Purification
Careful selection of downstream processing conditions is a must.
Minimizing Variation in Vial Withdrawal Practice
Vial adapters can reduce variation of volume withdrawn from injectable drug vials.
Quality Agreements for Contract Manufacturers
A well-constructed quality agreement can be an important tool to enable effective collaboration between owner and CMO.
The Relevance of Industry Technical Associations
Industry associations play a strong role in helping the pharmaceutical industry meet challenges.
Managing Cleaning Validation in Multi-Product Biologics Facilities
Developing and maintaining a current master plan for cleaning in multi-product facilities are crucial.
Assessing a Risk Management Program
Program review can help quality risk management live up to the promise of ICH Q9.
Challenges and Trends in Biopharma Facility Design
Experts discuss the future of modular manufacturing and the challenges that biopharma manufacturers face in facility design
Evaluating Design Margin, Edge of Failure, and Process Capability
Design space generation is encouraged in new product development.
BioPharm International, September 2014 Issue (PDF)
Click the title above to open the BioPharm International September 2014 issue in an interactive PDF format.
