ABPI News

In any industry an initiative of major proportions occasionally appears that has the potential for a fundamental revision of traditional or, at least, evolved thinking. One such initiative came up at the end of August - namely the FDA's concept paper on a Risk-Based Approach to GMP. That and the accompanying documentation - particularly the Q&A document that goes with it - make for interesting reading and will certainly be scrutinised in some depth by all interested parties in the coming months.

On the face of it the proposals would seem to be a pragmatic review of the traditional FDA approach to GMP and, if this is the case, then it is to be welcomed. Beyond that it may well herald a more global review of the topic of GMP. In a world where we are all seeking global harmonisation of standards, this may well trigger a wider review of the degree to which we can continue to 'ratchet' requirements without a full assessment of the costs/benefit equation.

Beyond national or trading group boundaries, the implications for the various GMP mutual recognition agreements that have been agreed or are in the process of ratification with FDA will have to be considered in the light of the proposals

The FDA paper is a major contribution to the GMP debate and deserves full attention and consideration. It is early days in the consultation process but it behoves anyone involved in GMP - regulator, industrialist or practitioner - to read carefully the proposals, to comment and to follow the debate as it unfolds.