2. Current standards and standards applicable to risk management

In the pharmaceutical industry, risk management has become a regulatory obligation and one of the cornerstones of a company's quality policy.

From the point of view of GMP, only quality risk management is concerned, i.e. risks associated with the quality, safety and efficacy of medicines. Nevertheless, companies that apply these risk management approaches in areas other than quality may be able to provide answers that are admissible during inspections.

In response to the new FDA initiative , the ICH published the Q9 Quality Risk Management guide – QRM in 2005. This guide was reproduced as a Guidance...