The challenge of achieving zero visible defects (i.e., particulates) in parenteral drugs will require a coordinated effort at all stages of the supply chain, particularly in the production and filling of primary containers.
Using ISA-88 batch architecture standards can simplify communication between manufacturing execution and process control systems to improve the efficiency of such human activities as sampling and electronic batch recordkeeping.
Multi-faceted powder characterization, including measurement of dynamic properties, can be used to correlate powder properties and process performance to support equipment selection, optimization, and troubleshooting.
CPhI’s Annual Report discusses the implications of QbD, continuous processing, excipient criticality, and process validation on pharmaceutical manufacturing and predicts a steady shift to continuous manufacturing.
Oct 01, 2015 PTSM: Pharmaceutical Technology Sourcing and Management
By Pharmaceutical Technology Editors
Vetter plans to invest approximately 300 million Euros during the course of five years to expand drug product manufacturing and logistic services in Germany; upgrades will include an improved RABS system for aseptic processing.