Classification of GMP-Observations in the Various Inspectorates

GMP News
21 November 2007

Classification of GMP-Observations in the Various Inspectorates

Many regulatory agencies and inspectorates have internal documents for their inspectors with the purpose to classify observations noted during inspections and to ensure uniformity among the classification of deficiencies. These documents give indications what a company might expect during and after an inspection.

While comparing these documents, one can see that deficiencies are rated similarly between the agencies.

The FDA for example will consider the issuance of a Warning Letter or other regulatory action in the case of a failure to conduct investigations and resolve complaints (source: Compliance Program Guidance Manual for FDA Staff 7356.002).

Canada’s Health Products and Food Branch Inspectorate has listed deficiencies like absence of a recall procedure, distribution practices that would not permit an adequate recall procedure or no system in place for complaint handling in their Annex 2 of their Guide 0023 Risk Classification of GMP Observations.

This is comparable to Australia’s classification of deficiencies: no system or procedure in place for handling complaints will also lead to a major deficiency.

For more detailed information go here:

Programme Tip:

Get detailed information on how to practically implement the requirements defined in the ICH Guideline Q9 “Quality Risk Management”.

Wolfgang Schmitt
On behalf of the European Compliance Academy (ECA)


Go back

GMP Conferences by Topics