When the FDA started its initiative "cGMPs for the 21st century," it also introduced the "risk-based approach." What the Agency understands by this approach and how the implementation could consequently look like, has not yet become very clear.

At the GMP Conference held in Athens from 15 to 18 March 2004, Douglas Ellsworth, District Director of the New Jersey District and Chairman of the Field Drug Committee, presented his ideas of FDA's "Risk Management in Drug Quality."

In his lecture, he also referred to the ICH Concept Paper on risk management of 11 November 2003. This Paper neither gives a general risk definition, nor does it describe methods and applications. When speaking of risks in connection with drug quality, Ellsworth always referred directly to quality itself and thus also to identity, potency, bioavailability, purity, correct labelling etc.

Interestingly enough, he distinguished between product and process risk analysis. In the context of product risk analysis, he also mentioned the severity and probability of an occurrence as general elements. These are clear hints of an FMEA.

In contrast to this, regarding the process risk analysis, he referred mainly to the term critical control point, which indicates an HACCP analysis.

Ellsworth expects of exactly these critical control points to have validated limits.

According to D. Ellsworth, in the future, the FDA itself intends to prioritise its cGMP inspections in keeping with a "risk-based framework" (see illustration).