Shared API inspections project declared a success
pharmafile | August 9, 2011 | News story | Manufacturing and Production | API, EMA, FDA, TGA, pharma manufacturing news, regulatory inspections
A two-year facility inspection programme carried out by regulators in the USA, Europe and Australia has been deemed a success and looks likely to be extended.
The active pharmaceutical ingredient (API) inspection programmes – conducted by the EMA and European Directorate for the Quality of Medicines (EDQM), the FDA and the Australian Therapeutic Goods Administration (TGA) – was set up in late 2008 with the intention of lightening the load of inspection teams and avoiding duplicative work.
Teams from the three agencies shared inspection information, which helped them adopt a risk-management approach to inspections and decrease duplicate inspections.
Over the course of the two-year pilot, they added 1,110 sites to a Master List of facilities, which included data such as the APIs produced at the site, and the date and outcome of the last and the date of the next planned inspection.
One agency could tap into the information supplied by another to help decide whether to postpone or expedite its own inspection.
The participants identified 97 sites that were common to all three regions, resulting in the exchange of nearly 100 inspection reports, helping to avoid duplicate inspections. They also carried out joint inspections on nine facilities, including five in India and one each in China, Croatia, Mexico and Japan.
As a result it is estimated that the overall number of API facilities inspected by the three authorities went up, indicating that cooperation was helping to improve the breadth of regulatory oversight of the API sector.
“Efforts to reduce the number of duplicate inspections should be continued as it allows saving costly inspectional resources,” according to a report on the pilot programme. “It also reduces the number of repeated often similar inspections to which the API manufacturers are subjected … and increased the number of inspections performed of value to more than one authority”.
There were other concrete examples of the benefits of collaboration. In one case, the FDA prohibited imports of a company’s products on the grounds that its facility failed a European inspection. In other cases, corrective actions mandated in one agency’s inspection report were verified by a different agency during their subsequent inspection.
Commenting on the initiative, Deborah Autor, FDA deputy commissioner for global regulatory operations and policy, said: “It is imperative that the FDA works closely with its counterparts in order to ensure the safety and quality of products and the integrity of clinical trials. We cannot do it alone”.
Phil Taylor
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