It is clear know that Risk Management for the pharmaceutical industry is mandatory and there is no way around.
If you look at actual EMA and FDA inspection findings risk based decision taken is expected by the industry.
As an annex of EU GMP Guide, ICHQ9 was approved in November 2005 and implemented in the US, EU and Japan.
The expectation of making risk based decisions in a planned and formal manner which meet agency expectations is key for the whole pharmaceutical industry. But this is not only important to survive regulatory inspections but will give high value to your business and your company.
This will put you in a position from daily fire fighting to proactively mange your particular risks. It is company responsibility to decide on the right level of quality risk management by using well know risk management tools and ranking the risk with methods like FMEA (Failure mode and effect analysis).
These tools, the process and application are very well described in the publication from 31.Jannuary 2011.
Click here for ICHQ9