Quality risk management becoming increasingly important

 

Indentifying varying levels of risk and appropriate responses is increasingly at the heart of global pharmaceutical companies’ manufacturing strategy. This is one of the most significant changes to pharmaceutical manufacturing since the advent of good manufacturing practice (GMP) in the late 1960s.

 

Manufacturing in the Global Pharmaceuticals Industry: Key drivers, company strategies and regulations (3rd Edition) says that a new paradigm of Quality Risk Management (QRM) will inform decision-making so risks should be accessed as a precursor to deciding what action and at what level is appropriate. This follows on from the FDA’s 2002 acceptance that stringent regulations have tended to result in a stifling of innovation within the industry. Together with  regulators from Europe, Japan and other parts of the world, they are adopting a risk-based and scientific approach to manufacturing to overcome this tendancy.

 

“There is a new paradigm in pharmaceutical manufacturing; processes like Quality by Design and Process Analytical Technology are becoming increasingly important,” says Dr Kate McCormick, the report’s author. “It has long been a mantra of quality management that quality must be built in to the product at the start of the process. In the context of pharmaceutical manufacturing, this means starting at the R&D stage, particularly during product and process development. The more that is known about the product characteristics and process variables, the better these can be controlled and the greater certainty there will be over the quality of the product. This greater level of scientific product knowledge will lead to flexibility in regulation".

 

The 135 page report charts the recent history of this approach as well as providing a comprehensive overview of pharmaceutical manufacturing in the world today.

 

For more information or to order your copy of Manufacturing in the Global Pharmaceuticals Industry: Key drivers, company strategies and regulations (3rd Edition) visit the Urch Publishing site: