September 2006 Issue


  • QbD Takes Biopharma by Storm

    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 FDA’s Moheb Nasr for his perspective.

  • Tales from the Front: Applying Fieldbus at Genzyme, Part 1

    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.

  • Washington Letter: FMEA as a Packaging Tool

    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?

  • What's In a Color? One Form of I.D.

    Pearlescent pigments, now approved by the FDA, may add another level of product differentiation, potentially protecting the consumer and establishing a stronger brand identity.

  • From the Editor: Only Connect!

    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?

  • cGMP Violations: Beware Complacency

    Are companies adequately following cGMPs? This article examines some recent FDA 483s and Warning Letters and provides a compliance level index.