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News about GMP/cGMP

2018-09-07

FDA Publishes Internal Policy on Inspection Priorisation

On 5 September 2018, the US FDA has published a 7-page Manual of Policies and Procedures, MAPP, on how manufacturing facilities are prioritized and scheduled for surveillance inspections. This step should add greater transparency around the “Site Selection Model (SSM)”, used by CDER staff.

 

It explains how a facility’s compliance history, recall trends, time since last inspection, inherent risk of the drug being manufactured, processing complexity and other factors are all weighed and considered.

According to FDA commissioner Scott Gottlieb, the SSM ensures that inspections are prioritized on potential risks to patients and that all resources are used efficiently, regardless to a site’s location. For manufacturing facilities in other countries, inspections are conducted by staff in foreign offices, those on temporary duty assignments, or staff that travels internationally to conduct the inspection. The numbers of Fiscal Year 2017 show how complex this task is:

  • From an overall of about 5,063 pharmaceutical sites worldwide, 3,025 sites are foreign-based. In 2017, FDA conducted 1,453 inspections which included 762 inspections outside the US.

In addition, to maximize resources and efficiency, the FDA also pursued opportunities to collaborate with other countries, e. g. the Mutual Recognition Agreement with the EU last year. This ensures that drug inspections conducted by foreign regulatory authorities meet U.S. requirements. Collaborating with other national authorities is one step to address the challenges posed by a globalized supply chain. The FDA participates in the Pharmaceutical Inspection Co-Operation Scheme (PIC/S), which focuses on harmonizing how inspections are conducted and participates in the International Council for Harmonisation (ICH).

Source:

FDA: Press Release

FDA: MAPP

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