Regulatory Monitoring of API Manufacturers - FDA, TGA, EMA and EDQM express Common Objectives for Inspections Collaboration

In December 2008, a pilot programme on international collaboration on GMP inspections of API manufacturers was launched by regulatory authorities. The FDA, the Australian Therapeutic Goods Administration (TGA), 5 European national supervisory authorities as well as the EDQM have participated in this 2-years programme. The purpose of the programme was to establish work sharing for information exchange between the authorities. Unnecessary inspections were partly avoided thanks to concrete measures like, for example, the organisation of joint inspections and the sharing of inspection reports. We reported about this programme in our News from 17 August 2011.

Over the 2 years, it had become obvious that the programme would have to be continued and extended. Indeed, in the context of global networking of manufacturing, processing, transportation and storage of pharmaceutical APIs, intermediates and bulk ware, efficient monitoring can only be ensured through international collaboration. The more national authorities actively participate in this common monitoring and inspection initiative, the more of the objectives can be reached.

On 6 March 2012, the EMA published a paper entitled "Programme to rationalise international GMP inspections of active pharmaceutical ingredient/active substances manufacturers - Terms of reference and procedures for participating authorities". This publication presents the conditions which must be met by the monitoring authorities to actively take part in the collaboration programme but also precisely defines the requirements for collaboration and information sharing. Here are the minimum data on the site to inspect which must be made available for the cooperation partners who are interested in this inspection or its results:

  • AS / API name(s)
  • Site Master File
  • Product Quality Review
  • Manufacturing process description (at least flow-chart)
  • Buildings/lines to be inspected

The involved authorities agree on the final scope and timelines for the inspection. The inspection team will be composed of inspectors from maximum three national regulatory authorities. The requirements laid down in ICH Q7 will be the reference standard. If required, other GMP guidelines will be taken into consideration.

As the ground rules for the inspection cooperation programme have been clearly formulated, the intention is also to encourage other national regulatory authorities to actively participate in the programme. Yet, the authors of the document expressly point out that authorities who may not yet be in a position or do not wish to become participating authorities may request access to the information being shared. This will also be applicable for International Organisations and Non Governmental Organisations organising GMP inspections (Audits) of API manufacturers. Information about which data will be made available and how to get them is not dealt with in the publication.

Please also see the "Terms of reference and procedures" of the "Programme to rationalise international GMP inspections of active pharmaceutical ingredients/active substances manufacturers".

Dr Gerhard Becker
CONCEPT HEIDELBERG (a service provider entrusted by the ECA Foundation)

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