Device manufacturers operating in Australia will face more intense inspections if their CAPA plans fail to satisfy the Therapeutic Goods Administration after three tries following an inspection.
Jenny Hantzinikolas, director of the TGA’s Inspections, Manufacturing Quality Branch within the Medical Devices and Product Quality Division, said during a recent industry meeting that the agency had revamped its close-out process and that it would be taking a closer look at companies’ CAPA plans. Companies with recurring issues would get longer inspections, and the agency would request additional evidence.
Device manufacturers that market products in Australia are required to have their quality systems recertified every five years, and at least two abbreviated site inspections are conducted during a five-year recertification period.
At the close-out of an inspection, the agency assigns a manufacturer a rating of A1 (high level of compliance), A2, A3 or U (unacceptable). Manufacturers assigned an A1 will not be inspected as often.
The agency will spend more time at manufacturing plants for A2 and A3 manufacturers to review evidence from their CAPA plans, she said.
The most common deficiencies in 2016 related to poor investigations, automated systems, validation processes and quality control.
The TGA said that companies with a history of A1 compliance that receive an A2 or A3 rating, will lose their good compliance status and will be subject to more frequent and longer inspections.
For example, a reinspection of a manufacturer that achieved an A2 rating may require an additional half day at the next inspection, and an additional full day may be required where the previous inspection resulted in an A3 rating.
Highly compliant manufacturers may receive a lower inspection rating for reasons such as implementing new product lines, equipment replacements or upgrades, staffing changes, increasing production volumes and other changes.
During the 2016 to 2017 financial year, TGA inspectors closed out 95 percent of device inspections within their targeted timeframe.
Domestic inspectional outcomes show that about 55 percent of inspections resulted in A2 (moderate) compliance issues in 2012 to 2013 and dropped to about 35 percent the following year. Companies that received an A1 rating remained fairly steady around 30 percent of inspections and then peaked to about 52 percent in 2014 to 2015, and then dropped to about 30 percent in 2015 to 2016.
Domestic companies that ranked A3 represented about 20 percent of inspections in 2010 and dropped to less than 10 percent in FY 2014 to 2015. The lowest U rating was near 4 percent of inspections in 2011 but has dropped to nearly zero in recent years.
For overseas inspections, about 40 percent of companies received an A1 rating in 2013 to 2014, and about 40 percent received an A2 rating. Those with an A2 rating peaked slightly in 2014 and then dropped to about 25 percent in 2015. A3 rankings for foreign devicemakers ranked around 19 percent of inspections in 2010, and then dropped to about 9 percent in 2011 and have remained fairly steady. U rankings for foreign firms remained about the same as domestic companies.