Manufacturer inspections - a risk-based approach to frequency

30 September 2016

We employ a risk-based approach to the frequency of manufacturer inspections. Our inspection frequency matrices are used to guide the frequency of inspections. In planning our inspection program, we also take into account:

  • emerging trends
  • recalls
  • adverse events
  • results of laboratory testing
  • feedback and inspections undertaken by other regulators
  • compliance history
  • significant changes within the company, including:
    • key personnel appointments or resignations
    • building
    • key equipment
    • product lines
    • intention to cease business.

This information is collated in the Manufacturer Profile, which may be updated at any time to reflect recent events or changes to risk factors. Where necessary, an unannounced inspection may be undertaken at any time outside of the regular inspection cycle, or the date of the next scheduled inspection may be brought forward.

The TGA inspection frequency matrices take into account:

  • the product and process risks
  • the manufacturer compliance history.

There is a TGA inspection frequency matrix for:

Inspection frequency matrix -medicines and blood, tissue and cellular therapies

We recognize that manufacturers with a history of high level compliance, as evidenced by repeat A1 inspection ratings, do not need to be inspected as frequently as other manufacturers. Our reinspection frequencies therefore include extended reinspection frequencies and reduced inspection scope (i.e. shorter inspections) for such manufacturers.

It is important to note that extended reinspection frequencies and reduced inspection scopes will no longer apply if a manufacturer with a history of A1 inspection ratings receives an A2 or A3 rating. This raises the question about whether such a manufacturer will need to start from the beginning, i.e. as though the next A1 rating is their first A1 rating. It is our experience that previously highly compliant manufacturers may receive a lower inspection rating for reasons such as implementing new product lines, equipment replacements/upgrades, staffing changes, increasing production volumes and others.

In planning our next inspection of a manufacturer we do take into account the number of deficiencies identified at the previous inspection. This is to allow inspectors sufficient time to assess the corrective and preventive actions taken by the manufacturer to address the issues. For example, we anticipate that a reinspection of a manufacturer that achieved an A2 rating may require an additional half day at the next inspection, whereas an additional full day may be required where the previous inspection resulted in an A3 rating.

In cases where there are compliance concerns we will continue to apply our full suite of regulatory tools, including unannounced inspections, close out inspections and bringing forward planned inspections, to protect the health and safety of Australian consumers.

Inspection frequency matrix - listed medicines

We also recognise the different levels of risks posed by medicines listed on the Australian Register of Therapeutic Goods (ARTG) compared with those registered on the ARTG. We have therefore developed a reinspection frequency matrix for listed medicines that reflects the lower level of risk associated with the use of these products.

Risk rating Third and subsequent consecutive A1 Second consecutive A1 First A1 A2 A3
L 48 + reduced scope inspection 48 42 30 18
Other
  • Reinspection only if there is risk information or complaint
  • Biennial compliance review (desk top)

Inspection frequency matrix - registered medicines and blood, tissue and cellular therapies

A higher level of risk is associated with these products and the processes to make them. The reinspection frequency matrix recognises this while taking into account compliance history of the manufacturer.

Risk rating Third and subsequent consecutive A1 Second consecutive A1 First A1 A2 A3
H 36 + reduced scope inspection 36 24 18 12
M 36 + reduced scope inspection 36 30 20 15
L 36 + reduced scope inspection 36 + reduced scope inspection 36 24 18

Inspection frequency matrix - medical devices

Under the regulatory framework for Australian medical device conformity assessment, sites are required to have their quality systems re-certified at five year intervals. At least two surveillance inspections are to be conducted (abbreviated reviews) between these intervals, resulting in the entire quality system being reviewed in this period.

Re-inspection period in months
Risk category Compliance Rating
Acceptable Unacceptable
A1 A2 A3
High 16 14 12 Determined by Review Panel
Medium High 20 16 12 Determined by Review Panel
Medium Low 20 16 12 Determined by Review Panel
Low N/A N/A N/A Determined by Review Panel