September 2006 Issue
Quality by Design has lost its buzzword status as it becomes a reality for more biopharma companies. Contributing Editor Angelo De Palma examines how Wyeth, Schering and other firms are advancing the concept, and interviews FDAs Moheb Nasr for his perspective.
Isolation and too narrow a focus limits possibilities for your career and life, your organization, and the industry. Sure, you may be doing your job right, but are you doing the right job?
Where orphan drug manufacturing is concerned, waste is the real enemy. Rather than choosing sides, Genzyme is using all competing Fieldbus protocols in a biopharma manufacturing suite whose products combat a very rare, often fatal disease.
ProsCon Ltd.'s MES specialist Paul Murray offers tips for ensuring the success of pharma MES implementations.
Failure Modes and Effects Analysis promises to become a more important risk assessment tool for pharmaceutical manufacturing. Could its use be required for labeling and packaging?
Moving to a single-step process removed capacity bottlenecks while reducing solvent use; the Clarecastle plant recouped its investment in less than a year
Pearlescent pigments, now approved by the FDA, may add another level of product differentiation, potentially protecting the consumer and establishing a stronger brand identity.
As they work on the next generation of bioanalytics, researchers in Ireland are establishing a new model for industrial-academic collaboration.
Quality by Design cuts across job functions and requires a vision of the big picture. This requires connecting data, concepts and people. Is your organization doing this?
Are companies adequately following cGMPs? This article examines some recent FDA 483s and Warning Letters and provides a compliance level index.