The European Medicines Agency (EMA) issued the report in conjunction with national authorities in France, Denmark, Ireland, Italy, the UK, the US, Australia, Canada, Japan, as well as the European Directorate for the Quality of Medicines (EDQM) and the World Health Organisation (WHO) earlier this month.
The collaboration enables the sharing of information about good manufacturing practice (GMP) inspections of active pharmaceutical ingredient (API) plants located outside the national involved in the programme.
International API Inspection Programme 2011-2016
The report indicates that between 2011 and 2016, participating authorities carried out 1,333 inspections at 458 manufacturing sites of common interest. Of the 18 countries targeted in the report, the majority of inspections were conducted in India (49%) and China (36%).
The European Medicines Agency said the overall objective of the programme is to “ensure more sites are monitored by making best use of inspection resources worldwide through increased cooperation, mutual reliance between participating regulatory bodies, reducing duplication of inspections and increasing inspection coverage.”
Ingredient manufacturer Johnson Matthey (JM) told us the collaboration benefits both API manufacturers and regulators.
“International collaboration on GMP inspections will reduce the burden of redundant inspections on GMP-compliant API manufacturers while allowing the health authorities to expand their inspection reach to protect more patients,” JM’s global director of quality assurance and regulatory affairs Londa Ritchey told us.
Shared inspections of API manufacturers may facilitate the approval timing on applications filed in multiple regions for the same drug product, she added.
From a regulatory standpoint, “Removing inspection redundancies will also allow authorities to take a risk-based approach and focus on repeat inspections of non-compliant API manufacturers,” Ritchey said.
‘More transparency and efficiency’
According to the report, the number of ingredient manufacturing site inspections is on the rise, but more can be done to reduce the number of duplicate visits.
Participating authorities reported the programme “successfully strengthened their interactions to improve the oversight of API manufacturers worldwide.”
Additionally, the number of API site inspections has increased over the six years, which in turn, has encouraged the exchange on inspection information between participating authorities, according to the report.
The EMA said increasing the sharing of information has “brought more transparency and efficiency for the planning and realisation of GMP inspections.”
The report also states that the number of duplicate inspections decreased over the six-year period, and “efforts to reduce the number of duplicate inspections should be continued as it allows more strategic use of inspectional resources and reduces the burden to all participants, including on the API industry.”
However, not all challenges have yet to be addressed. Authorities have requested more active participation from all members and hopes to set up a formal electronic sharing platform as well as a comprehensive list of API manufacturers in each participating country.
Nonetheless, the report states that “overall the level of satisfaction of the participants to the survey indicates that the programme is beneficial for the authorities in a number of ways.”
Moving forward, participating authorities support the programme’s continuation: “All believe that this also translates into value for the API industry because of reduce workload to host inspections.”