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
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).
Canadas 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 Australias classification of deficiencies: no system or
procedure in place for handling complaints will also lead to a major deficiency.
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On behalf of the European Compliance Academy (ECA)