Quality risk management becoming increasingly important
(1888PressRelease) September 11, 2008 - Identifying acceptable levels of risk will increasingly be at the heart of global pharmaceutical companies’ manufacturing strategy, says a new report from URCH Publishing. 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 it could not inspect every manufacturing site in the world producing medicines for the US market and would therefore move to a risk management approach to decide priorities for inspection. Other industry regulators are following suit and adopting a risk-based and scientific approach to manufacturing.
“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,” argues Dr McCormick, a consultant who has over 25 years experience in international manufacturing.
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.
More information about Manufacturing in the Global Pharmaceuticals Industry: Key drivers, company strategies and regulations (3rd Edition) priced at £1,1125 go to:
About URCH Publishing Ltd
URCH Publishing Ltd is an independent business information publisher dedicated to delivering quality information products to the global pharmaceuticals industry. The company is based in London, UK. For more information contact URCH Publishing on +44 (0) 20 7060 1099 or email press[a]urchpublishing.com.