Inspections relating to manufacturing authorisations

The Compliance Department of the HPRA is responsible for conducting inspections to determine whether manufacturing operations are in compliance with the EU Guide to Good Manufacturing Practice (GMP). Following inspection, a report is issued to the inspected site listing any non-compliance or deficiencies observed during the inspection. Deficiencies are classified into three categories; critical, major and other. Criteria for judging deficiencies as critical, major or other are detailed below.

Critical Deficiency:

A deficiency which has produced, or leads to a significant risk of producing either a product which is harmful to the human or veterinary patient or a product which could result in a harmful residue in a food producing animal.

Major Deficiency:

A non-critical deficiency: which has produced or may produce a product, which does not comply with its marketing authorisation or

which indicates a major deviation from EU Good Manufacturing Practice or (within EU) which indicates a major deviation from the terms of the manufacturing authorisation or which indicates a failure to carry out satisfactory procedures for release of batches or (within EU) a failure of the Qualified Person to fulfill his legal duties or a combination of several “other” deficiencies, none of which on their own may be major, but which may together represent a major deficiency and should be explained and reported as such.

Other Deficiency:

A deficiency, which cannot be classified as either critical or major, but which indicates a departure from good manufacturing practice.

(A deficiency may be “other” either because it is judged as minor, or because there is insufficient information to classify it as a major or critical).

Inspected sites are requested to reply to the deficiencies stating proposed /actual corrective action(s) relating to the individual deficiency and date(s) for completion of the corrective action(s). It is expected that any critical or major findings are addressed immediately.