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:
• http://www.fda.gov/ora/cpgm/default.htm
• http://www.hc-sc.gc.ca/dhp-mps/compli-conform/gmp-bpf/docs/gui_23_tc-tm_e.html
 

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