SBCONSULT

Regarding recalls a steep increase had been seen over the last two years, during which also a shift had occurred. Most recalls hand been initiated by the FDA and not by industry. Since 1997 by far most of the recalls had been related to GMP-deviations, followed by lack of sterility assurance, lack of potency, dissolution problems and problems with analytical method validation... This has lead the FDA to change its inspectional approach to a "Quality System based Inspections" already known from the Center for Devices and Radiological Health (CDRH): "Quality Systems Inspection Technique", August 1999, see... SBConsult offers services to pharmaceutical industry - drugs, biologicals and medical devices

Also known as: SBConsult Aps

Primary location: København