FDA Presentation on Risk Management in Drug Quality

GMP News No. 407

19 April 2004

FDA Presentation on
Risk Management in Drug Quality

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

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

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

Interestingly enough, he distinguished between product and processrisk analysis. In the context of product risk analysis, he also mentionedthe severity and probability of an occurrence as general elements. Theseare clear hints of an FMEA.

In contrast to this, regarding the process risk analysis, he referredmainly to the term critical control point, which indicates an HACCPanalysis.

Ellsworth expects of exactly these critical control points to havevalidated limits.

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



Sven Pommeranz


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