Regulatory Focus™ > News Articles > 4 > Regulators' Teamwork on Inspecting API Manufacturers Supports Better GMP Oversight, Report Finds

Regulators' Teamwork on Inspecting API Manufacturers Supports Better GMP Oversight, Report Finds

Posted 13 April 2018 | By Zachary Brennan 

Regulators' Teamwork on Inspecting API Manufacturers Supports Better GMP Oversight, Report Finds

A half-dozen years of international collaboration in inspecting active pharmaceutical ingredient (API) manufacturing sites reveals an increase in the number of sites inspected, further supporting the exchange of information on inspections as a way to improve GMP oversight, according to a recent report.

The report, assessing the “International Active Pharmaceutical Ingredient Inspection Programme,” from 2011 to 2016, concluded that participating authorities recommend the continuation of this international collaboration.
Current participants include the US Food and Drug Administration (FDA), European Medicines Agency (EMA), World Health Organization and other regulators from Denmark, the UK, Ireland, Italy, France and Australia (TGA).

The program allows for the exchange of early feedback on sites identified as GMP non-compliant before information is made public, such as through FDA warning letters or European statements of GMP non-compliance.

“Future re-inspection plans are also shared and, in some cases where interest is shared, other participating authorities in the program may choose to follow-up by proposing a joint inspection. In addition to inspection outcomes, participating authorities also exchange early notices of regulatory actions or license suspensions or any other national enforcement measures against non-compliant manufacturers,” the report says.


FDA and European authorities took the lead in performing the most inspections, though the report concluded: “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.”

Part of that effort should involve lifting the legal requirements at some national levels to reduce the unnecessary duplication of inspections.


The report also offered several recommendations for improving the program, including establishing a formal, central repository with access to a master list of inspection reports, and encouraging program participants to be more active during monthly teleconferences.

Participants should determine clear deliverables to be assessed at regular intervals, the report says, noting that there should be a review of re-inspection frequencies/schemes among participants, efforts to better understand how to maintain metrics such as: number of inspections deferred, number of inspection reports exchanged and the inclusion of other regulatory authorities worldwide, if there is interest.

Report on the International Active Pharmaceutical Ingredient Inspection Programme 2011 – 2016

Categories: Regulatory News

Regulatory Focus newsletters

All the biggest regulatory news and happenings.