Issue Archive

Therapeutic Dose: Ready, Aim, Aim, Aim…
Risk management in the 21st century: We have the tools, but do we have the will?

From the Editor: Curing Pharma’s China Syndrome
Accountability - on the part of finished drug manufacturers as well as their API suppliers - will prevent future quality and P.R. disasters

Outsourcing Biopharma Water Treatment
Benefits to a service contract are often seen during validation and the Factory Acceptance Test. Contract partners can also help optimize spare parts maintenance.

Applying the Final Touches
Drug-packaging combinations require greater attention as knowledge of interactions between packaging materials and their enclosed drug product increases.

Grasping Lyophilization Product and Process Parameters for Biopharma
A clear understanding of product and process parameters is essential if freeze drying is not to remain a “trial and error” process. This excerpt from an authoritative book* summarizes the basics.

NIR Calibration Transfer
A practical approach can allow to applying multivariate analysis to calculate calibrations for multiple analyzers in a network.

CAPAS: Too Much or Not Enough?
A strategic CAPA plan requires transparent information and a clear understanding of root causes.

Bridging the Gap
Despite talk of IT and process control convergence, the two functions are still disconnected, from each other and from manufacturing, at many pharmaceutical companies today.

Because This Isn’t Hogwarts…