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Testing of Active Pharmaceutical Ingredients (APIs)


Testing of Active Pharmaceutical Ingredients (APIs) is a routine activity in many Official Medicines Control Laboratories (OMCLs) of the General European OMCL Network (GEON). OMCLs also make important contributions to the development and improvement of European Pharmacopoeia monographs by their active participation in different Ph. Eur. working groups at the EDQM.

EU legislation in the field of medicines and, in particular, different provisions of the Falsified Medicines Directive (FMD) 2011/62/EC, which came into force as of 2013, entail the need for better surveillance of APIs originating from unauthorised illegal sources and, consequently, the necessity to establish appropriate measures to counteract them are also aknowledged and considered in Strategy Paper II (2010) of the Heads of Medicines Agency (HMA), as well as the Council of Europe's Convention on the counterfeiting of medical products and similar crimes involving threats to public health (referred to as MEDICRIME Convention).


API Working Group

In order to react to these developments in the most efficient way, an OMCL working group dedicated to the testing of APIs was established in 2011. The task of the API Working Group is to develop strategies and programmes for the OMCL Network that contribute to the efforts of the European Health Authorities to ensure the high quality and safety of APIs on the European market into the future.


Achievements of the API Working Group to date

One major outcome of the work of this group has been to issue a GEON Position Paper that outlines the general risks with APIs and the possible contributions of the OMCL Network in the co-ordinated surveillance of APIs. The paper, which has been adopted by the OMCL Network, also includes strategies for the future surveillance of APIs.

In February 2013, a new database on API testing was launched. This new computer application, which is only accessible to members of the OMCL Network and national competent authorities, allows the sharing of information with respect to the testing of substances for pharmaceutical use (including excipients and herbals) in the OMCL Network with a focus on APIs. This database should promote API testing in the OMCL Network and collaboration in this field.


Work plan of the API Working Group

Topics currently in the work plan of the API Working Group include:

  • Improved information-sharing with respect to API testing in the OMCL Network; appropriate measures for the maintenance of an API testing information IT platform with controlled access and the routine reporting of API testing in the Annual Reports of the GEON members.
  • Support in the development and maintenance of a general Risk Assessment tool for the planning of national market surveillance programmes with focus on critical APIs.
  • Improvements in sample planning through collaboration with other stakeholders (in particular national GMP inspectors and customs officers).
  • Scientific discussion to foster Market Surveillance Studies (MSS) on APIs for the determination of the quality, but also the authenticity and sources, of tested materials by different measures, such as the application of “fingerprint” techniques and “chemometric analysis”.
  • Development of training programmes to support these tasks.


Benefits of Chemometrics for OMCLs

In view of the shared interest in the possibilities offered by chemometrics and on the basis of the positive experience of the API fingerprint studies conducted by the API Working Group, it was decided to draft a chemometrics guide for beginners in the field to help them analyse their analytical data.

In addition to an introduction to the topic for interested parties, the document also provides more advanced information for individuals looking to build on their knowledge of chemometrics.

Please note that the names of the software mentioned in the document are given as a guide only.

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