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News about GMP/cGMP

2018-04-18

EMA: Report on International API Inspection Programme

With an increasing globalisation of medicine manufacturing and supply chains, regulatory authorities across the world consider themselves responsible to cooperate in the overall interest of public health. Pharmaceutical companies that are outsourcing their production of APIs to contract manufacturers located in other countries have led to an increased need for inspections, to ensure adequate oversight of these facilities.

The European Medicines Agency (EMA) and its European and international partners have successfully strengthened their interactions to improve the oversight on API manufacturers worldwide. With this step duplicate inspections can be reduced or even avoided and the overall inspection coverage has increased.

 

The initiative started with a pilot in 2008-2010, and became a full programme in January 2011. The report published today gives an overview on the activities carried out by the

  • EU Member States (France, Denmark, Ireland, Italy and the United Kingdom)
  • EDQM (European Directorate of the Quality of Medicines and Healthcare)
  • FDA (United States Food and Drug Administration)
  • TGA (Australian Therapeutic Goods Administration) and the
  • WHO (World Health Organization)

between 2011 and 2016. Health Canada and the PMDA only joined at a later stage; therefore the report does not cover information on their activities.

This international collaboration allowed the sharing of information GMP inspections of manufacturers of APIs that were located outside the participating countries.

The overall objective was to

  • better distribute inspections capacity/inspection resources worldwide through increased cooperation
  • allow more sites to be monitored
  • reduce unnecessary duplication/ reducing duplication of inspections
  • increase inspection coverage
  • strengthen mutual reliance between participating regulatory bodies
  • rationalise GMP inspections of API manufacturers at international level
  • foster cooperation and mutual confidence between participating regulators through better communication and exchange of information on inspections

What are the results?

Over six years, 1,333 inspections were carried out at 458 manufacturing sites of common interest. These sites were located in 18 different countries, most of them in India (49%, 226) and China (36%, 165). 15% of inspections (67) were carried out in the rest of the world. During this period, the programme has grown both in membership and sites of common interest. The level of information shared between participants has increased and overall inspection coverage grew, benefiting global public health.

Total inspections by all
participating authorities (2011-2016)
European Authorities (inkl. EDQM) 301
FDA 762
TGA 130
WHO 131
Total unique inspections
1333

New tools for work sharing and exchange of information were developed and used by the participants to share inspection reports and to organise joint inspections of API manufacturers located outside the participating regions. Increased transparency and visibility of inspections performed by participating authorities allowed a successful collaboration between authorities on sites of common interest and increased the number of inspections performed of value to more than one authority.

The following tables show the number of sites of common interest shared between more than two/three or all participants:

Number of sites of common interest shared
between at least two participating authorities

TGA
FDA WHO
Europäische Behörden (inkl. EDQM) 136 350 41
FDA
x 176 17
TGA
x x x

Number of sites of common interest shared among
three participating authorities
European Authorities (incl. EDQM) - TGA - FDA
(keine WHO)
117
European Authorities (incl. EDQM) - TGA - WHO
(keine FDA)
15
European Authorities (incl. EDQM) - FDA - WHO
(keine TGA)
30
FDA - TGA - WHO
(no European Authorities incl. EDQM)
17

Number of sites of common interest to
all participating authorities
All Participants
15

Another important area of exchange was an early feedback on sites identified as GMP non-compliant. Within the scope of existing confidentiality agreements, the participating authorities regularly exchanged information on sites that were considered GMP non-compliant before they were  made publicly available by the relevant authority (such as through Warning Letters or Statements of GMP Non-Compliance).  Future re-inspection plans were also shared and other participating authorities in the program could choose to follow-up by proposing a joint inspection.

However, the analysis of the results from the past six years also indicates that some challenges remain to be addressed, such as a more active participation from all members of the group, the need for a formal electronic sharing platform and performing regular reviews of the programme results. The participating authorities concluded that this programme is beneficial and agreed to continue their collaboration.

Sources:

Report

EMA News

EMA International collaboration

 

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