OR WAIT null SECS
December 01, 2007
It is becoming evident that quality risk management within regulated, life sciences environments is a valuable component of an effective quality management system (QMS). A QMS provides a proactive and systematic means to identify, analyse, evaluate and control potential process and product quality issues during development, manufacturing, distribution and marketing throughout the entire product life cycle.
A well-devised QPP, which has been agreed on and signed by both parties, saves time and makes it easier to complete activities such as design, installations and tests.
Never has greater pressure been applied to pharmaceutical manufacturers. Shelf space competition for branded drugs has reached aggressive proportions and now even prescription drugs vie for pricing and delivery. Against this is a backdrop of ever-increasing downward price pressures, and a spectrum of progressively more stringent legislative and quality requirements. Finally, regional markets now demand different tamper evidence technology, anticounterfeiting measures and safeguards against interference by biological terrorists. Much of which points to the need for innovation in packaging - not just in terms of pack styles and sizes, but also cost.
November 02, 2007
Editors' Picks of Pharmaceutical Science & Technology Innovations
Thin are the lines that separate stability, statistics, and chaos.
October 02, 2007
Our files pull up lost contracts, poor competitive tactics, and an over-ambitious employee.
October 01, 2007
High performance liquid chromatography has become an efficient technique at the production scale, and simulated moving bed chromatography provides several benefits during processing.
September 02, 2007
Poor processing and misguided projections lead to trashed product.
September 01, 2007
The recently published Orange Guide 2007 contains significant changes to the GMP requirement placed on pharmaceutical manufacturers, but there have been additional changes to good distribution practice that should not be overlooked.
The authors discuss how companies facing ever-evolving regulatory requirements can address and assess compliance risk in their operating practices.