Shared API inspections project gains traction
pharmafile | October 26, 2010 | News story | Manufacturing and Production |Â Â API, EDQM, EMA, FDA, TGA, manufacturing compliance, pharma manufacturing, regulatory affairs, regulatory inspectionsÂ
A three-way initiative between regulatory authorities in the EU, US and Australia on the inspection of facilities making active pharmaceutical ingredients (APIs) is generating “palpable” results, according to a report on its first 18 months.
The project was set up in early 2009 to enable participating agencies to leverage limited resources and cast a wider net over pharma manufacturing standards in third-country locations.
However, there is still additional work to be done as the teams from the EMA and European Directorate for the Quality of Medicines (EDQM), the FDA and the Australian Therapeutic Goods Administration (TGA) are still duplicating some inspections, says the report.
All told, the three agencies’ teams inspected more than 1,000 API manufacturing facilities since the start of the pilot project, all of which have been entered into a Master List which can be accessed by any of the authorities. Each entry contains information such as the APIs produced at the site, the date and outcome of the last inspection and the date of the next planned inspection.
Some of the achievements of the initial pilot phase are already clear, including an overall increase in the number of inspected facilities, a decrease in duplicate inspections, and an increase in the number of inspections of value to more than one authority.
“Because of the sharing of information and inspection reports it is self-evident that resources were freed up for other priorities, including inspection of sites which are not shared by other participants and/or which were never inspected before,” notes the report.
According to the interim report, the Master List contains 499 sites submitted by the EU, 352 from the FDA and 195 from the TGA, for a total of 1,046.
The pilot is being continued for an additional six months to provide a full two years’ of collaboration, and a final report is expected before the end of the year.
• Meanwhile, Health Canada has said that it will shortly start applying a new ranking system to observations noted during inspections of medical device facilities, according to recently-issued guidance document. The rankings will be classified on the basis of their level of risk.
Phil Taylor
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