March 2008 Issue
Risk management in the 21st century: We have the tools, but do we have the will?
Accountability - on the part of finished drug manufacturers as well as their API suppliers - will prevent future quality and P.R. disasters
Benefits to a service contract are often seen during validation and the Factory Acceptance Test. Contract partners can also help optimize spare parts maintenance.
Drug-packaging combinations require greater attention as knowledge of interactions between packaging materials and their enclosed drug product increases.
A practical approach can allow to applying multivariate analysis to calculate calibrations for multiple analyzers in a network.
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.
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.
A strategic CAPA plan requires transparent information and a clear understanding of root causes.