Cooperation of international authorities for inspecting API manufacturers

The International API Inspection Programme is an initiative of various European and Non-European authorities and organisations with the goal of increasing the efficiency of their individual inspection activities and reducing unnecessary redundancies. The way to reaching this goal essentially is a cooperation in the area of GMP inspections of API facilities and information exchange.

After a two-year pilot phase from 2008 to 2010, the programme, which was meant to run for six years, was launched in 2011. The following authorities and organisations took part in the programme and submitted their data: EDQM, FDA, TGA Health Canada, MHLW, PMDA, WHO as well as the supervisory authorities of France, Denmark, Ireland, Italy and the United Kingdom. Upon evaluating all data, the EMA published their "Report in the International Active Pharmaceutical Ingredient Inspection Programme 2011 - 2016" in March this year.

The report contains information on the planning and execution procedure for inspections as well as on the shared platforms used for information exchange (e.g. EudraGMDP, DCIQA/"COMSTAT", etc.). The report also includes key figures for the performed GMP inspections, itemised by the competent authority and location of the API facility. One of the key messages of the report is the following:

During the six-year-period, a total of 1.333 inspections at 458 facilities with shared interest had been performed. The production sites were located in 18 different countries - 49% of them in India, 36% in China.

One of the essential planning tools is a master list of all API production facilities that at least two of the national agencies participating in the inspection programme have an interest in. With their membership in the programme, the authorities agree to include the following points in their inspection planning:

  • the results of an already performed inspection by another agency;
  • in case another agency already has an inspection planned, check whether an expansion of the inspection scope can be requested from said agency in order to conserve resources and prevent duplicate inspections.

Although it is the declared goal of the programme to prevent duplicate inspections at facilities, there was still an average of 2.3 inspections performed per GMP-non-compliant facility and 1.7 inspections per GMP-compliant facility. In chapter 6.3 "Decrease in 'duplicate' inspections", the reasons for this are given: e.g. the master list had not been consulted during inspection planning or the master list was missing important information on scheduled inspections.

The last chapter of the report (8."Recommendations for future action and path forward") lists several suggestions for improvement that show where the crucial points of the cooperation as already described in chapter 6.3 lie:

  • Establishing a centralised database with access permission for all members, in which the master list is filed,
  • Expansion of the EudraGMDP planning module for all European authorities and participants in the programme,
  • Web-based training sessions for inspectors regarding the preparation, execution and follow-up of GMP inspections,
  • Appeal to all members of the programme to actively take part in the monthly teleconferences.

Despite the heterogeneous composition of members of the inspection programme, its ambitious goals may be achieved through continuous improvements. This does not only benefit the supervisory authorities, who can deploy their resources more efficiently, but also the API manufacturers, who now have less GMP inspections to host. Ultimately, the patient also benefits, since the safety of drug products in the market can be better ensured through increased regulatory oversight.

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