TGA GMP Consultant

As a TGA GMP consultant, I’m often asked… “Do you have any examples of Critical and Major deficiencies?”

ByTrevor Updated on

There can often be some confusion between the terms ‘Critical’ and ‘Major’ deficiency. On the 1st May 2013, the TGA helped to answer this question by issuing a list of typical inspection deficiencies and their risk categorisation! This is of immense help to the industry.

Critical deficiency

A critical deficiency is a deficiency which has produced, or leads to, a significant risk of producing a harmful product. It is a serious situation in which regulatory action will be considered. TGA examples of critical deficiencies include the following (where it can be reasonably expected that the guidance definition will be met):

  • Lack of sterilisation validation (relevant to all sterile products)
  • Falsification or misrepresentation of analytical results or records (relevant to all manufacturers)
  • No master batch documents (relevant to all manufacturers)
  • Grossly unsuitable premises so that there is a significant risk of contamination (relevant to all manufacturers)
  • Release of materials or finished product for a Registered medicine not meeting specifications. (For listed medicines that assignment of a critical classification should first be discussed with the relevant regulator.)

Major deficiency

A major deficiency is a deficiency which indicated a major deviation from Good Manufacturing Practice. Some examples of major deficiencies include the following:

  • Lack of validation of critical processes (applicable to all medicines, but could be critical for low dose/high potency products; partially sterilisation processes for sterile devices)
  • No data available to establish the shelf-life of registered medicines (relevant to all manufacturers of registered medicines as it is their responsibility. This should be referred to the relevant product regulator)
  • Insufficient manufacturing space that could lead to mix-ups
  • Inadequate initial and ongoing training and/or no training records
  • Test methods not validated
  • Deviations from instructions not approved

To see the full TGA list, click here.

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