Globalisation of Manufacturing and Distributing Medicinal Products Causing Troubles according to the FDA

On the FDA website, you can find the slides of a presentation made by Robert Sklamberg, Director of CDER's Office of Compliance in May 2013. The topic deals with the challenges presented by globalisation of manufacturing and distributing of drugs.

He defines the following "challenges":

  • More dispersed facilities supplying global market
  • Increasing volume of imported products
  • More outsourcing of manufacturing
  • Greater complexity in supply chains
  • Imports coming from countries with less developed regulatory systems
  • Greater opportunities for economic fraud

Supply chains for finished drugs are taken as example on the slides (i.e. falsified products sold to suppliers, stolen products reintroduced in the supply chain, etc ...). The FDA would like to counter the threats through collaboration with other authorities. For this, modern global data information systems should be implemented. In this context, the significance of risk analyses increases to be able to focus on the real important aspects - also with the help of private third parties.

One of the aspects of its global engagement is FDA's foreign offices. By now, the FDA is represented in the following places: Mexico City, San Jose, Santiago, London, Brussels, Amman, Pretoria, Mumbai, New Delhi, Beijing, Shanghai and Guangzhou. Collaboration with the PIC/S is another important aspect which brings many advantages, among other things: prior knowledge of revisions to EU GMP regulations and PIC/S guidances, joint inspection training exercises, and participation in PIC/S expert circles. Moreover, one of the objectives is the creation of a common EIR Template (Establishment Inspection Report) to all PIC/S members. Another objective consists in confidence building measures between the FDA and EU authorities to help sharing information on inspections and GMP-related documents.

A part of the presentation focuses on quality. According to Sklamberg, quality cannot settle only on "meeting regulators standards" but also on one's own standards. On one slide, the expectations on quality of Dr Janet Woodcock, director of CDER, are listed:

  • Proactively identify & promptly correct issues
  • design/qualify robust operations
  • maintain equipment and facilities
  • Implement robust quality management systems

In the presentation, Sklamberg includes diverse statistics of product recalls made between fiscal year 2007 and the first quarter of 2013. Over the last three fiscal years, the major reasons for recalls have been GMP deviations and impurities/degradation products. Challenges of regulating OTC drugs and of FDASIA can be found on the last slides of the presentation.

Conclusion: globalisation of manufacturing and distributing medicinal products has become an issue for the FDA which should be countered through enhanced collaboration with the PIC/S and EU authorities. Over the last three fiscal years, the major reasons for recalls have been GMP deviations and impurities/degradation products.

Click here to access the complete presentation.

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