Classification of deficiencies (medicinal product manufacturers)
Following the adoption of the Australian Code of GMP for Medicinal Products (16 August 2002) <http://www.tga.gov.au/docs/html/gmpcodau.htm>, the Manufacturer Assessment Branch classifies deficiencies (previously referred to as nonconformities) observed during GMP audits of medicinal product manufacturers as "critical", "major" and "other". The change of classification has been made to harmonise with the European approach to classifying deficiencies.
Critical, major and other deficiencies are defined below.
Note
- Classification of a deficiency is based on the assessed risk level and may vary depending on the nature of products manufactured, eg in some circumstances an example of major deficiency may be categorised as critical.
- A deficiency that was reported at a previous audit and not corrected may be reported in a higher classification.
Critical deficiency
A Critical Deficiency is a deficiency that has produced, or may result in a significant risk of producing a product that is harmful to the user. Critical deficiencies must be rectified before licence or certification is granted. (Not applicable to Medical Device audits.)
Major deficiency
A Major Deficiency/Non-conformity is a non-critical deficiency/non-conformity that:
- has produced or may produce a product which does not comply with its marketing authorisation (in some circumstances this could be critical); and/or
- indicates a major deviation from the Code of GMP or QMS standard; and/or
- indicates a major deviation from the terms of the manufacturing licence, GMP approval (overseas manufacturers), or Conformity Assessment Certificate; and/or
- indicates a failure to carry out satisfactory procedures for release of batches; and/or
- indicates a failure of the person responsible for QA/QC to fulfil his/her duties; and/or
- consists of several other deficiencies / non conformities, 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.
Agreed proposed corrective actions including an implementation timeframe and or evidence of completion is required for each deficiency / non-conformity prior to a licence or certification being granted.
Other deficiency
An Other Deficiency/Minor Non-conformity is a deficiency/non conformity that cannot be classified as either critical or major, but indicates a departure from the applicable standard. Agreed proposed corrective actions including an implementation timeframe is required for each deficiency/non-conformity before a licence or certificate is granted.