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Quality by Design (QbD)

Jamie Clayton, operations director at Freeman Technology, explains how comprehensive, process relevant characterisation of wet granules can lead to control of tablet CQAs and assist design space definition in the manufacture of an OTC medicine. Read more

Opinion

Tim Freeman, managing director, Freeman Technology on how to optimise granulation using real-time analysis Read more

News

Piramal Enterprises' pharma solutions division will call on pharma companies to start complementing the principles of Quality by Design (QbD) to advance product and process quality at CPhI Read more

News

Pharmaceutical manufacturers are constantly striving to develop new methods of reducing costs and environmental impact by using the dry compaction method to produce granules from powdered and micronised products. The control of the compaction and... Read more

Technology

Stuart Needleman, President and Chief Operating Officer, Aptuit, has announced that Aptuit provides integrated product development of inhaled dosage forms through its Chemistry Manufacture and Control (CMC) group located at The Aptuit Center for... Read more

Technology

Telstar has reinforced its pharmaceutical consulting area by driving two new business lines that will offer consulting services for quality systems in GXP environments. Specifically, Telstar has incorporated a new Quality by Design (QbD)... Read more

Technology

Extractables, leachables and QbD

Extractables and leachables are increasingly becoming a cause of major concern for both the pharmaceutical industry and regulatory bodies. The development of unique packaging, novel formulations and drug-coated medical devices has exacerbated... Read more

20 Nov 2012 17:29 Regulatory Affairs Blog