No Risk Management or Poor Risk Management?

Nostrapharmus calls for good risk management practice to satisfy regulatory demands and business needs.

'At least we tried' is a phrase unlikely to receive any sympathy when you are held to account for knowing about a risk, but not addressing it appropriately - especially in an industry where public responsibilities are beyond those of ordinary business ethics.  Safety is paramount and what you don't know will hurt you.

As Nostrapharmus says, the minimum requirement has to be an explanation of the actions taken, or not, as the case may be.  This, alongside evidence to support the decisions made, is a start to exercising the decisions made, is a start to exercising the principles of GRMP (Good Risk Management Practice).  Such principles must maximise the benefits of risk management across the business while also ensuring the satisfaction of emergent requirements from the regulators.  It is imperative, when implementing risk management, to put mechanisms into place to manage the required actions before getting too excited about where the greatest risks exist in the business.

If you would like to read the article in full please click on the pdf link below:

No Risk Management or Poor Risk Management

or to view the magazine, follow the link below, the article can be found on pages 49-50

http://viewer.zmags.com/publication/9d1586ab#/9d1586ab/51

About Pharma magazine
Aimed at the international pharmaceutical and bio-pharmaceutical community, Pharma magazine covers every aspect of manufacturing from R&D to finished product. With a worldwide circulation of more than 40,000 individuals it is the first truly global magazine for the pharma industry, bringing together the disciplines of discovery and development, the drug manufacturing process and the resultant business and management issues.For further information visit the Pharma magazine website www.pharma-mag.com