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Revised risk management strategy for manufacturers of medicines and blood, tissues and cellular therapies

30 September 2016

We have updated our manufacturer risk management framework to take into account compliance history as well as product and process related risks.

In determining inspection frequencies (time between inspections) and scope (what we assess on site), we take into account product and process risks. We have updated this risk framework by taking into account our experience with the previous framework. This has resulted in the addition of an ‘Other’ risk category, which includes homeopathic products and some non-sterile active pharmaceutical ingredients. In these cases inspections will be conducted when we have information to warrant doing so. This does not mean we will cease oversight of these manufacturers. Instead, we will rely on information obtained via desk top assessments. Where this, or other information obtained by TGA, raises areas of concern we may conduct an onsite inspection, either announced or unannounced.

We have also revised the reinspection frequencies to reflect our experience over the past few decades. For example, our experience has shown 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.

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