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Medicines manufacturers

Classification of deficiencies (medicinal product manufacturers)

【Update Date:2010-02-01】 unit:品質監督管理組

DEFINITION OF DEFICIENCIES

TO BE USED IN PIC/S INSPECTION REPORT

1. 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.

2. 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 PIC/S Good Manufacturing Practice;
or
(within PIC/S) 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 PIC/S) a failure of the authorised person to fulfil his/her required 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.

3. 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 major or critical)