Risk Classification of GMP Deviations

GMP News No. 301

4 April 2003

Risk Classification of GMP Deviations

Pharmaceutical companies, and increasingly also manufacturers of activepharmaceutical ingredients, are subject to supervision by the authorities.

Therefore, observations noted duringinspections - including those noted in customer audits - are crucialbecause the results may, under certain circumstances, have an influence onthe economic situation.

Since 1 February 2003, the MRA (MutualRecognition Agreement) with Canada is in force (see GMPNews of 25 February 2003). Hence the GMP systems of Canada and the ECare considered to be comparable, also with regard to their officialsupervision.

The Canadian supervisory authority (HPFB)has recently published a very interesting draft on the topic of "RiskClassification of Good Manufacturing Practices Observations" on theinternet for discussion:

The main classification as:

  • Critical observations
  • Major observations
  • Other observations

can be compared to that used in thenational inspections by authorities and customers.

However, the Canadians have 3 furtherrisk classes, which then lead to the corresponding observations.

The most interesting thing about thisdraft is the detailed list of deviations, sorted according to thedifferent GMP areas (premises, equipment, personnel, etc.) and categorisedwith regard to their risk classes and the resulting observation class.

Sven Pommeranz


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